[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"National Institute of Mental Health (NIMH)\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":533},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,50,0,25,[9,52,79,99,120,145,169,187,207,219,236,245,255,275,293,317,335,366,389,398,419,427,438,477,508],{"id":10,"slug":4,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":23,"conditions":24,"keywords":29,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":40,"lastUpdatePostDateStruct":41,"startDateStruct":44,"completionDateStruct":46,"leadSponsor":48,"locationsCount":51},"100054178",false,"NCT07640802","Psychotherapy for Irritability in Youth: Comparing Active Treatment to Nonactive Psychoeducation Supportive Psychotherapy","Psychotherapy for Irritability in Youth: Comparing Active Treatment to Non-Active Psychoeducation Supportive Psychotherapy","* INCLUSION CRITERIA FOR YOUTH\n\n  1. Age 8-16.5 years\n  2. Caregiver and\u002For child reports irritability as a primary clinical concern. Specifically, compared to his\u002Fher peers, the child exhibits markedly increased reactivity to negative emotional stimuli that manifests verbally or behaviorally. For example, the child responds to frustration with extended temper tantrums (inappropriate for age and\u002For precipitating event), verbal rages, and\u002For aggression toward people or property.\n\n  2a. Such events occur, on average, at least three times a week.\n\n  2b. This irritability is impairing in at least two of three domains (home, school, peers)\n\n  3\\. Patients must be fluent in English\n\n  3a. Participants must be able to speak and read English. This study evaluates English language, manualized psychotherapies. The intervention materials, therapist and rater training and supervision procedures, fidelity ratings, and primary outcome measure are\n\ncurrently available and validated only in English. Because psychotherapy relies on nuanced verbal exchange, use of translation or interpreters could alter treatment content, affect therapeutic alliance, compromise fidelity, and limit accurate clinical risk assessment. Examining fidelity and alliance\u002Fsupport are our primary and secondary objective in this study. Therefore, enrolling non-English speakers can introduce a confound to these research questions. Restricting enrollment to English-speaking participants is therefore necessary to ensure participant safety and scientific validity in this trial. Critically, this eligibility criterion is based solely on the language requirements of the intervention and study procedures and is not intended to exclude participants on the basis of race or ethnicity or any other factors.\n\n4\\. On the basis of record review and interviews with child and parent, the research team agrees that the child s response to his\u002Fher current treatment is no more than minimal (i.e. CGI-S of 3 or more).\n\n5\\. Must have no planned changes in outpatient psychiatric treatment regimen, which can include psychotropic medications and\u002For psychotherapeutic interventions, two weeks prior to enrollment.\n\nINCLUSION CRITERIA FOR PARENT\n\n1. Parent of a child eligible for this protocol that can attend 12 parent sessions\n2. Fluent in English\n\nEXCLUSION CRITERIA\n\nParticipants will be screened to exclude participants who would not be able to engage in psychotherapy.\n\n1. Active major depressive disorder or history of psychosis, bipolar I disorder, Level 2 or 3 autism spectrum disorder, active severe substance use disorders (within the last month), conduct disorder, have active suicidal intent or plan as detected on screening instruments.\n2. IQ \\\u003C 70\n3. Past or present medical or neurological condition, disease, disorder, genetic finding, or injury that, in the opinion of the Investigator, may significantly increase the potential risks of study participation, reduce or compromise a subject s ability to fully comply with all study requirements for the duration of the study or may compromise the integrity of the data.\n\nEXCLUSION CRITERIA FOR PARENTS\n\n1. IQ \\\u003C 70\n2. Have any serious medical, mental health, or any condition that interferes with participation, such as active psychosis.\n3. Current alcohol or substance use or dependence (excluding nicotine) within the past 3 months of sufficient magnitude to require independent, concurrent treatment intervention (e.g. Antabuse or opiate treatment but not including self-help groups).","ALL","8 Years","17 Years",{"count":20,"type":21},300,"ESTIMATED","OBSERVATIONAL","Background:\n\nIrritability is defined as proneness to anger that may impair a person s ability to function. It is a common reason for why some children need mental health care. Yet no therapies have been developed just to target irritability. Researchers want to compare different types of therapy for irritability.\n\nObjective:\n\nTo test different types of therapy for children and teens with severe irritability.\n\nEligibility:\n\nPeople aged 8 to 16.5 years with severe irritability. Their parents are also needed.\n\nDesign:\n\nParticipants will have 28 study visits in 18 months.\n\nThey will have a baseline visit. They will answer questions about their mood, behavior, and daily life.\n\nAll parents and children will have 12 therapy sessions. Sessions will be once a week; they will last 30 to 60 minutes. Some of the child sessions may be done by telehealth.\n\nEach parent and child will have 1 of 3 therapy types:\n\nExposure therapy (child). Participants will face things that make them angry. A therapist will help them practice managing their anger.\n\nManagement therapy (parent). Therapists will coach parents on ways to manage their child s behaviors.\n\nPsychoeducation\u002Fsupportive psychotherapy (child and\u002For parent). Participants will talk with therapists about their or their child s feelings and behaviors. They will list their problems and goals; build coping skills; learn to relax; improve communication; and work on managing stress.\n\nSessions may be videotaped. Participants may opt out of being recorded.\n\nParticipants will have phone calls every 2 weeks during therapy. They will answer questions about how they are doing. Follow-up calls will continue for 1 year after therapy.",[25,26,27,28],"Irritability","Disruptive Mood Dysregulation Disorder","Oppositional Defiant Disorder","Attention Deficit Hyperactivity Disorder",[25,30,31,32,33,34,35,36,37,38],"Parent Management Training","Psychosocial Treatment","Exposure Therapy","Children","ANGER","Pediatric","Cognitive Behavioral Therapy","Psychoeducation","Supportive Therapy","NOT_YET_RECRUITING","2026-07-10",{"date":42,"type":43},"2026-07-13","ACTUAL",{"date":45,"type":21},"2026-07-16",{"date":47,"type":21},"2037-12-31",{"name":49,"class":50},"National Institute of Mental Health (NIMH)","NIH",1,{"id":53,"slug":4,"hasResults":11,"nctId":54,"briefTitle":55,"officialTitle":55,"acronym":4,"eligibilityCriteria":56,"healthyVolunteers":57,"sex":16,"minAge":58,"maxAge":59,"enrollmentInfo":60,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":61,"conditions":62,"keywords":66,"overallStatus":74,"whyStopped":4,"lastUpdateSubmitDate":40,"lastUpdatePostDateStruct":75,"startDateStruct":76,"completionDateStruct":4,"leadSponsor":78,"locationsCount":51},"100053293","NCT01087281","Top-Down Attentional Control of Visual-Processing","* INCLUSION CRITERIA:\n\nAll Subjects\n\n1. All subjects will be 18 years of age or older and have at least a high school education.\n2. Capacity to provide their own informed consent, understand and cooperate with study procedures.\n3. Able to read and write in English to guarantee understanding of all written and spoken instructions, which are in English.\n\nPatients:\n\n1. Unilateral or bilateral focal lesions of prefrontal, parietal, occipital or temporal cortex, or amygdala.\n2. At least three months post-stroke, lobectomy and or neurosurgical resection.\n\nHealthy volunteers:\n\n1\\. Neurologically normal and in good general health.\n\nEXCLUSION CRITERIA\n\nPatients:\n\n1. Any neurological or psychiatric disorder not related to the focal lesion (e.g., epilepsy, schizophrenia, etc.). Epilepsy patients who have undergone surgery and as a result are seizure free may be recruited.\n2. Previous head injury.\n3. Present or past (within past 6 months) drug or alcohol abuse or addiction as determined by a qualified study neurologist\u002Fpsychiatrist.\n4. Radiation treatment to the brain during a three-month period prior to the experiment.\n\nHealthy volunteers:\n\n1. Any neurological or psychiatric disorder (e.g., epilepsy, schizophrenia, etc.)\n2. Previous head injury.\n3. Present or past (within past 6 months) drug or alcohol abuse or addiction based on DSM-5 criteria as determined during History and Physical exam.\n\nADDITIONAL EXCLUSION CRITERIA FOR MRI SCAN:\n\nPatients and Healthy volunteers:\n\n1. Women who are pregnant and women of child-bearing potential who refuse to undergo a urine pregnancy test will be excluded from fMRI experiments.\n2. Subjects who have contraindications to MRI scanning will be excluded from fMRI experiments but included in cognitive experiments. These contraindications include:\n\n   1. central nervous system aneurysm clips;\n   2. implanted neural stimulator;\n   3. implanted cardiac pacemaker or defibrillator;\n   4. cochlear implant;\n   5. ocular foreign body (e.g., metal shavings);\n   6. insulin pump;\n   7. metal shrapnel or bullet;\n   8. any implanted device that is incompatible with MRI.\n3. Conditions that preclude scanning, e.g., morbid obesity, claustrophobia.\n\nADDITIONAL EXCLUSION CRITERIA FOR TASKS INVOLVING COLOR DISCRIMINATION:\n\nPatients and Healthy volunteers:\n\nSubjects who are determined during screening or history and physical exam to be color-blind will be excluded from participating in certain tasks that involve color discrimination.",true,"18 Years","100 Years",{"count":20,"type":21},"Background:\n\n\\- Previous studies have shown that people with certain types of brain damage may have particular problems paying attention and processing things that they see. Researchers are interested in comparing how people with brain damage and without brain damage process visual images.\n\nObjectives:\n\n\\- To better understand the areas of the brain involved in paying attention to things that are seen.\n\nEligibility:\n\n\\- Individuals at least 18 years of age who either have had damage to one or both sides of specific parts of the brain (e.g., stroke, injury, certain neurosurgery procedures) or are healthy volunteers.\n\nDesign:\n\n* The study involves 4 to 10 visits to the NIH Clinical Center over 1 to 2 years. Each visit will last approximately 2 hours.\n* Participants will be screened with a medical history and physical examination, and may have the cognitive testing described below during the same visit.\n* On the first visit and for at least one visit thereafter, participants will have cognitive testing to evaluate thinking and memory. These tests will be either written tests or computer-based tests.\n* Some participants will qualify for functional magnetic resonance imaging (fMRI) as part of the study. This part will involve a decision-making task that will be performed on a computer during the fMRI scan. Additional scans may be required as directed by the study doctors.\n* Some randomly selected participants will be asked to have magnetoencephalography (MEG), a procedure to record very small magnetic field changes produced by brain activity.\n* During the behavioral training, or fMRI or MEG scanning, participants may be monitored with equipment to track eye movements.",[63,64,65],"Focal Brain Lesion","Focal Lesions","fMRI",[67,68,64,69,70,71,63,72,73],"Visual Attention","Visual Cortex","Neurological Disorder","Functional Magnetic Resonance Imaging (fMRI)","Natural History","Healthy Volunteer","HV","RECRUITING",{"date":42,"type":43},{"date":77,"type":43},"2012-07-23",{"name":49,"class":50},{"id":80,"slug":4,"hasResults":11,"nctId":81,"briefTitle":82,"officialTitle":82,"acronym":4,"eligibilityCriteria":83,"healthyVolunteers":11,"sex":16,"minAge":84,"maxAge":18,"enrollmentInfo":85,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":87,"conditions":88,"keywords":91,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":40,"lastUpdatePostDateStruct":94,"startDateStruct":95,"completionDateStruct":96,"leadSponsor":98,"locationsCount":51},"100054278","NCT07566468","Role of Theta Frequency Oscillations in Proactive and Reactive Control Processes in Youth With Attention Deficit Hyperactivity Disorder (ADHD) and Obsessive Compulsive Disorder (OCD)","* INCLUSION CRITERIA\n\n  1. Ability to provide informed assent and parent consent\n  2. Age: 10-17 years\n  3. ADHD Group: Diagnosis of ADHD based on DSM-5 criteria\n\n     OCD Group: Diagnosis of OCD based on DSM-5 criteria\n\n     HV Group: No Neurological or Psychiatric diagnosis based on DSM-5 criteria\n  4. Wechsler Abbreviated Scale of Intelligence, Second Edition (WASI-II). WASI-II will be used as a measure of intellectual function. Children will be included when FSIQ \\> 70.\n  5. Normal or corrected to normal vision\n\nEXCLUSION CRITERIA\n\nParticipants will be screened to exclude participants in whom MRI or EEG might result in increased risk of side effects or complications or whose data would not be scientifically valid.\n\n1. Non-English Speakers\n2. Pregnancy\n3. Any implant, prosthesis or alteration of the body that, in the opinion of the investigator, would be unsafe with MRI or EEG or that would produce an artifact that would compromise the integrity of data;\n4. Active or History of psychosis, bipolar I disorder, Level 2 or 3 autism spectrum disorder, active severe substance use disorders (within the last month), have active suicidal intent or plan as detected on screening instruments;\n5. Individuals currently taking Stimulant medications who are unwilling or unable to not take the medication during study visit days.\n6. Past or present medical or neurological condition, disease, disorder, genetic finding, or injury that, in the opinion of the Investigator, may significantly increase the potential risks of study participation, reduce or compromise a subject s ability to fully comply with all study requirements for the duration of the study or may compromise the integrity of the data.\n7. For the HV group, any impairing current psychiatric diagnosis.","10 Years",{"count":86,"type":21},110,"Background:\n\nAttention deficit hyperactivity disorder (ADHD) is common in children. It can cause problems with attention and the ability to control actions and impulses. Obsessive compulsive disorder (OCD) is less common in children but not rare. It involves ongoing thoughts, urges, impulses, and repeated behaviors. Researchers want to study differences in brain activity between healthy children, those with ADHD, and those with OCD.\n\nObjective:\n\nTo learn more about how the brain controls thinking and behavior.\n\nEligibility:\n\nPeople aged 12 to 17 years with ADHD, OCD, or neither.\n\nDesign:\n\nParticipants will have 3 to 10 clinic visits in up to 1 year. Each visit will last 2 to 3 hours.\n\nThree visits are required:\n\nBehavioral. Participants will complete a computer task. Their mood, memory, attention, and thinking skills will be tested.\n\nEEG. Participants will undergo electroencephalography (EEG) to measure signals in their brain. Small electrodes will be placed on the scalp. A cap will be stretched over the head. Signals will be recorded while participants rest or do tasks on a computer.\n\nMRI. Participants will have a magnetic resonance imaging scan (MRI). They will lie on a table that rolls into a tube. The MRI will take pictures of their brain while they do tasks on a computer.\n\nSeven more visits are optional. These include 2 more EEG visits and 2 more MRI visits.\n\nThree will be magnetoencephalography (MEG) visits: MEG measures small magnetic field changes in the brain. A helmet with sensors will be placed on the head. Brain changes will be recorded while participants rest or do tasks on a computer.",[89,90,72],"ADHD","Obsessive Compulsive Disorder (OCD)",[92,93,65],"EEG","MRI",{"date":42,"type":43},{"date":45,"type":21},{"date":97,"type":21},"2029-05-31",{"name":49,"class":50},{"id":100,"slug":4,"hasResults":11,"nctId":101,"briefTitle":102,"officialTitle":103,"acronym":4,"eligibilityCriteria":104,"healthyVolunteers":57,"sex":16,"minAge":58,"maxAge":105,"enrollmentInfo":106,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":108,"conditions":109,"keywords":110,"overallStatus":74,"whyStopped":4,"lastUpdateSubmitDate":40,"lastUpdatePostDateStruct":116,"startDateStruct":117,"completionDateStruct":4,"leadSponsor":119,"locationsCount":51},"100053685","NCT00001360","Studies of Blood Flow to the Brain During Thought","Regional Cerebral Blood Flow Studies of Object Perception, Identification, Localization, and Memory","* INCLUSION CRITERIA:\n* Healthy adults, with at least a high school education, aged 18 to 65 years, will be recruited to participate in the study.\n* Able to read and write in English to guarantee understanding of all written and spoken instructions, which are in English.\n\nEXCLUSION CRITERIA:\n\nSubjects will be excluded if they:\n\n* have evidence of, or a history of:\n* major medical, neurological or psychiatric illness\n* serious head injury\n* learning disability-drug or alcohol abuse or dependence in the past 3 months, except nicotine\n\n-are taking prescription drugs or supplements that may affect brain function-\n\n-have serious vision or hearing problems\n\nIn addition to the above, additional exclusion criteria apply for all MRI studies:\n\n* Female subjects who are pregnant or have a positive pregnancy test 24 hours prior to an experiment will be excluded from neuroimaging studies.\n* All subjects will be questioned prior to MRI scanning for possible occupational exposure to metal slivers or shavings, which may have become accidentally lodged in the tissues of the head or neck. Subjects with surgical clips or shrapnel in or near the brain or blood vessels, subjects with cochlear implants, subjects with any metallic body in the eye or CNS, and subjects with any form of implant wire or metal device which may concentrate radiofrequency fields will be excluded from MRI scanning experiments because of possible risks during MRI scanning. Those whose history is suggestive of such a problem will also be excluded from the MRI portion of the experiments. They may still participate in the behavioral and MEG experiments.\n* Subjects unable to lie flat on their back for up to 3 hours may not be eligible to participate in MRI scans.","65 Years",{"count":107,"type":21},4100,"The purpose of this study is to use brain imaging technology to measure changes in blood flow to areas in the brain as individuals perform intellectual tasks.\n\nThis study will use functional magnetic resonance imaging (fMRI) to examine blood flow to areas of the brain as participants engage in tasks associated with visual perception, visual recognition, and memory.",[72],[111,112,113,114,115,71],"Cognition","Vision","Cortex","Visual Processing","Magnetic Resonance Imaging",{"date":42,"type":43},{"date":118,"type":43},"1993-09-17",{"name":49,"class":50},{"id":121,"slug":4,"hasResults":11,"nctId":122,"briefTitle":123,"officialTitle":123,"acronym":4,"eligibilityCriteria":124,"healthyVolunteers":57,"sex":16,"minAge":17,"maxAge":105,"enrollmentInfo":125,"targetDuration":4,"studyType":127,"phases":128,"briefSummary":130,"conditions":131,"keywords":134,"overallStatus":74,"whyStopped":4,"lastUpdateSubmitDate":40,"lastUpdatePostDateStruct":138,"startDateStruct":139,"completionDateStruct":141,"leadSponsor":143,"locationsCount":144},"100054265","NCT00018057","Study of Neuro-Cognitive Correlates of Pediatric Anxiety Disorders","* INCLUSION CRITERIA:\n\nALL JUVENILE SUBJECTS\n\n* Age: 8-17 (subjects who consent as 17-year-olds but turn 18 during the course of the study will be eligible to complete all procedures completed by other subjects who consent as 17-year-olds but do not turn 18).\n* Consent: can give consent\u002Fassent (Parents will provide consent; minors will provide assent)\n* IQ: all subjects will have IQ\\>70 (Assessment relies on either a WASI or assessment by trained clinical staff during the subject s screening visit. Completion of required activities during the screening visit requires an IQ above 70.)\n* Language: all subjects will speak English (Tasks in this protocol have not been validated in languages other than English)\n\nALL ADULT SUBJECTS\n\n* Age: 18-65\n* Consent: can give consent\n* IQ: all subjects will have IQ\\>70 (Assessment relies on either a WASI or assessment by trained clinical staff during the subject s screening visit. Completion of required activities during the screening visit requires an IQ above 70.)\n* Language: all subjects will speak English (Tasks in this protocol have not been validated in languages other than English)\n\nALL SUBJECTS WITH AN ANXIETY DISORDER\n\n* Diagnosis: Current Diagnosis of OCD, Social Phobia, Separation Anxiety, Generalized Anxiety Disorder, or Panic Disorder (Based on K-SADS (juveniles) or SCID (adults))\n* Symptom Severity: Clinically significant, ongoing anxiety symptoms (This will be documented by clinician review with patients and their families during at least two visits with families.)\n* Clinical Impairment: Clinically significant, ongoing distress or impairment from anxiety (This will be documented by clinician review with patients and their families during at least two visits with families.)\n\nALL PREVIOUSLY ENROLLED ADOLESCENT PATIENTS, CHILD AND ADULT HEALTHY VOLUNTEERS, AND ALL HEALTHY VOLUNTEERS TURNED PATIENTS\n\n* Diagnosis: Current Diagnosis of OCD, Social Phobia, Separation Anxiety, Generalized Anxiety Disorder, or Panic Disorder; No current diagnosis (Based on K-SADS (juveniles) or SCID (adults))\n* Clinical Impairment (as applicable): Clinically significant, ongoing symptoms (This will be documented by clinician review with patients and their families during at least two visits with families.)\n* Symptom Severity (as applicable): Clinically significant, ongoing symptoms (This will be documented by clinician review with patients and their families during at least two visits with families.)\n\nEXCLUSION CRITERIA:\n\nALL SUBJECTS\n\n* Any serious medical condition or condition that interferes with fMRI or M\u002FEEG scanning, and for patients electing medication, any condition that increases risk of SSRI treatment. (All patients will complete a medical history. Healthy volunteer participants will be medication- free and have no current serious medical conditions, based on a review of their medical history. Subjects only will be excluded from the MRI portions of the study based on this exclusion criterion.)\n* Pregnancy (Subjects only will be excluded from the MRI portions of the study based on this exclusion criterion.)\n* Current use of any psychoactive substance; current suicidal ideation as indicated by the presence of intent for engaging in suicidal behaviors; current diagnosis of attention deficit hyperactivity disorder (ADHD) of sufficient severity to require pharmacotherapy. (These factors could complicate treatment with an SSRI. No subject on medication will be accepted into the trial. Subjects will not be taken off of medications to enter the trial.)\n* Current diagnoses, major depressive disorder (MDD), post-traumatic distress disorder, conduct disorder. (These factors may be affected by SSRI treatment, influencing ability to detect effects on anxiety\u002Fsymptoms of depression. Of note, subjects who present with a diagnosis of MDD will not be eligible for inclusion at the outset of the study. However, youth with anxiety disorders frequently develop MDD when followed over time. Subjects will be allowed to remain in the study if they develop these diagnoses after enrollment.)\n* Past or current history of mania, psychosis, or severe pervasive developmental disorder. (These factors may be affected by SSRI treatment, influencing ability to detect effects on anxiety\u002Fsymptoms of depression. Of note, subjects who present with a diagnosis of MDD will not be eligible for inclusion at the outset of the study. However, youth with anxiety disorders frequently develop MDD when followed over time. Subjects will be allowed to remain in the study if they develop these diagnoses after enrollment.)\n* Recent use of an SSRI with failure to respond or tolerate SSRI treatment at an adequate dose and duration. (This is designed to exclude subjects who have failed a trial of an SSRI for their current problem with anxiety. For previously enrolled participants, including patients and healthy volunteers, current use of an SSRI does not exclude participation from follow-up research tasks.)\n* History of any (excepting nicotine-related and cannabis-related) DSM5-defined moderate to severe substance use disorder (or DSM-IV-defined substance dependence).\n\nHEALTHY ADULT SUBJECTS\n\n-Any current psychiatric diagnosis (Assessment relies on SCID)",{"count":126,"type":21},3500,"INTERVENTIONAL",[129],"PHASE2","Study Description:\n\nThis study examines relations between neurocognitive and clinical features of pediatric anxiety disorders. The study uses neuro-cognitive tasks, functional magnetic resonance imaging (fMRI), as well as magneto- and electro-encephalography (M\u002FEEG). Patients will be studied over one year, before and after receiving either one of two standard-of-care treatments: cognitive behavioral therapy (CBT) or fluoxetine, a serotonin reuptake inhibitor (SSRI). Healthy comparisons will be studied at comparable time points.\n\nPrimary Objectives:\n\nTo compare healthy youth and symptomatic, medication-free pediatric patients studied prior to receipt of treatment. The study seeks to detect relations between clinical features of anxiety disorders at baseline and a wide range of neurocognitive features associated with attention, memory, and response to motivational stimuli.\n\nSecondary Objectives:\n\n1. To document relations between baseline neurocognitive features and response to Cognitive Behavioral Therapy (CBT) or fluoxetine, as defined by the Pediatric Anxiety Rating Scale (PARS) and Clinical Global Improvement (CGI) Scale.\n2. To document relations between post-treatment changes in neurocognitive features and anxiety symptoms on the PARS following treatment with Cognitive Behavioral Therapy (CBT) or fluoxetine.\n3. To document relations among broad arrays of clinical, cognitive, and neural measures\n\nPrimary Endpoints:\n\nIndices of percent-signal change in hypothesized brain regions, comprising amygdala, striatum, and prefrontal cortex (PFC) for each fMRI and MEG paradigm.\n\nSecondary Endpoints:\n\n1. Treatment-response as defined by a continuous measure, the Pediatric Anxiety Rating Scale score (PARS), and a categorial measure, the Clinical Global Improvement (CGI) score.\n2. Levels of symptoms and behaviors evoked by tasks that engage attention, memory, and elicit responses to motivational stimuli.",[132,133],"Anxiety Disorders","Major Depressive Disorder",[65,135,136,115,137],"Emotion","Normal Volunteers","CBT",{"date":42,"type":43},{"date":140,"type":43},"2001-10-02",{"date":142,"type":21},"2029-01-01",{"name":49,"class":50},2,{"id":146,"slug":4,"hasResults":11,"nctId":147,"briefTitle":148,"officialTitle":149,"acronym":4,"eligibilityCriteria":150,"healthyVolunteers":57,"sex":16,"minAge":151,"maxAge":59,"enrollmentInfo":152,"targetDuration":4,"studyType":127,"phases":154,"briefSummary":156,"conditions":157,"keywords":161,"overallStatus":74,"whyStopped":4,"lastUpdateSubmitDate":40,"lastUpdatePostDateStruct":164,"startDateStruct":165,"completionDateStruct":166,"leadSponsor":168,"locationsCount":51},"100054007","NCT07169630","PET Imaging of Phosphodiesterase-4 (PDE4) in Volunteers With Alzheimer Disease (AD) or Mild Cognitive Impairment (MCI)","PET Imaging of Phosphodiesterase-4 (PDE4) in Volunteers With Alzheimer s Disease (AD) or Mild Cognitive Impairment (MCI)","* INCLUSION CRITERIA:\n\nParticipants will be referred by a physician with the suspected diagnosis of AD or MCI. However, the PI of this protocol will provide the final diagnosis. For this reason, this protocol will have just one consent form for participants suspected of having either AD or MCI.\n\nAD and MCI Study Groups:\n\nParticipants must meet all the following criteria:\n\n* Aged 50 or older.\n* Be able (or have their Legally Authorized Representative (LAR) be able) to understand the study and be willing to sign a written informed consent document.\n* Have been diagnosed by a neurologist or psychiatrist with MCI or AD.\n* Be in good general health as evidenced by medical history and physical examination.\n* Have had their radial artery pulse checked for the presence of adequate ulnar collateral flow and the absence of any metal or foreign objects in both wrists.\n* Agree to adhere to the lifestyle considerations.\n\nHealthy Volunteers:\n\nParticipants must meet all the following criteria:\n\n* Aged 50 or older.\n* Able to provide informed consent.\n* Be in good general health, as evidenced by medical history and physical examination, and have no cognitive impairment.\n* Have had their radial artery pulse checked for the presence of adequate ulnar collateral flow and the absence of any metal or foreign objects in both wrists.\n* Agree to adhere to the lifestyle considerations.\n\nEXCLUSION CRITERIA:\n\nBoth the study groups will be excluded if they meet any of the following criteria:\n\n* Clinically significant abnormalities on EKG or laboratory testing. This includes CBC and acute care panel (Na, K, Cl, CO2, creatinine, glucose, urea nitrogen).\n* Participants should not have taken non-steroidal anti-inflammatory drugs (NSAIDs) for two weeks prior to the PET scan. Aspirin, corticosteroids (with the exception of skin products), or immunosuppressants (e.g., methotrexate) must not have been taken in the prior month.\n* Have other major neurological or medical diseases that may cause cognitive dysfunction, such as structural brain diseases, metabolic diseases, paraneoplastic syndromes, infectious diseases, or other significant neurological abnormalities.\n* Have an unstable medical condition that, in the opinion of the investigators, makes participation unsafe (e.g., an active infection or untreated malignancy).\n* Are unable to travel to the NIH.\n* Have recent exposure to radiation related to research (e.g., PET from other research) that, when combined with this study, would be above the allowable limits.\n* Have an inability to lie flat and\u002For lie still on the camera bed for at least two hours, including claustrophobia, overweight greater than the maximum for the scanner, and uncontrollable behavioral symptoms, which will be screened by an interview with the volunteer and\u002For caregiver during the screening visit.\n* Participants must not have substance use disorder or alcohol use disorder.\n* Participants should not be under treatment or previously treated with an amyloid antibody such as lecanemab.\n* Are unable to have an MRI scan (e.g., because of pacemakers or other implanted electrical devices, brain stimulators, dental implants, aneurysm clips (metal clips on the wall of a large artery), metallic prostheses (including metal pins and rods, heart valves, and cochlear implants), permanent eyeliner, implanted delivery pumps, shrapnel fragments, or metal fragments in the eye).\n* Pregnancy or breast feeding.\n* HIV infection.\n* Non-English speaking participants.\n\nExclusion of Children:\n\nInclusion of children is not appropriate, because this protocol has more than minimal risk from radiation exposure without the possibility of direct benefit.\n\nExclusion of Pregnant or Breastfeeding Women:\n\nPregnant women will be excluded because this protocol involves exposure to ionizing radiation. Lactating women will be excluded because radioisotopes may be excreted in milk. We will not require contraception for this protocol to allow participants autonomy in medical decision-making. However, while we will not require contraception for woman of childbearing potential, we will perform a pregnancy test at screening and prior to all procedures to ensure participants are not pregnant\n\nExclusion of Participants who are HIV Positive:\n\nPersons with HIV infection are excluded because HIV infection itself may change cAMP signaling.\n\nExclusion of Non-English-Speaking Participants:\n\nNon-English-speaking participants will be excluded from participation in this study because neuropsychological testing is required by this protocol. This testing, which is critical for interpreting study results, has not been validated in other languages or when using a translator.","50 Years",{"count":153,"type":21},90,[155],"PHASE1","Background:\n\nAbout 5 million adults in the United States have age-related brain disorders. These include Alzheimer disease (AD), mild cognitive impairment (MCI), and other dementias. The number of people with these disorders will likely increase as the population ages and life span increases. Inflammation is thought to play a role in AD and MCI. Researchers want to know if an enzyme called PDE4B increases inflammation in people with AD or MCI.\n\nObjective:\n\nTo test whether medical imaging using a new radiotracer (\\[18F\\]PF-06445974) can measure PDE4B in the brains of people with AD or MCI.\n\nEligibility:\n\nPeople aged 50 years and older with AD or MCI. Healthy volunteers are also needed.\n\nDesign:\n\nParticipants will have up to 5 clinic visits with 3 imaging scans of the brain.\n\nThey will have be screened. They will have a physical exam with blood tests. This will include tests of their heart and nerve function, including memory.\n\nParticipants will have 2 positron emission tomography (PET) scans. One will use a standard radiotracer. The other will use the study radiotracer. They will receive each tracer through a tube attached to a needle inserted into a vein. During the scan with the study tracer, participants will have a second tube inserted into a vein in the wrist; this tube will be used to draw blood during the scan. Participants will lie on a bed that slides into a doughnut-shaped machine. These visits will take about 6 hours each.\n\nParticipants will have 1 magnetic resonance imaging (MRI) scan. They will lie on a bed that slides into a cylinder. This visit will take up to 2 hours....",[158,159,160],"Alzheimer s Disease","Mild Cognitive Impairment","Healthy",[162,163],"18F-PF-06445974","PET Imaging",{"date":42,"type":43},{"date":45,"type":21},{"date":167,"type":21},"2030-04-11",{"name":49,"class":50},{"id":170,"slug":4,"hasResults":11,"nctId":171,"briefTitle":172,"officialTitle":172,"acronym":4,"eligibilityCriteria":173,"healthyVolunteers":57,"sex":16,"minAge":174,"maxAge":175,"enrollmentInfo":176,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":178,"conditions":179,"keywords":180,"overallStatus":74,"whyStopped":4,"lastUpdateSubmitDate":40,"lastUpdatePostDateStruct":183,"startDateStruct":184,"completionDateStruct":4,"leadSponsor":186,"locationsCount":51},"100053497","NCT01434368","A Longitudinal Investigation of the Endocrine and Neurobiologic Events Accompanying Puberty","* INCLUSION CRITERIA - SAMPLE 1:\n\nChild volunteers will qualify for inclusion if they meet the following criteria:\n\n* Good general health and normal IQ; A normal IQ will be determined by the scores on Test of Irregular Word Reading Efficiency (TIWRE)\n* Age 8 years;\n* Body Mass Index (kg\u002Fm\\^2) between the 15th and 85th percentiles for age and sex according to the US Centers for Disease Control and Prevention 2000 growth charts;\n* A normal tempo of growth as determined by skeletal age within +\u002F- 1.64 standard deviations of chronologic age according to the Greulich and Pyle radiographic atlas (i.e., no evidence for precocious puberty or abnormal delay of maturation); Research criteria for determining bone age will be performed by the collaborating pediatric endocrinologist. This criterion is required only for the initial entry into this study and is not one of the inclusion criteria for subsequent visits;\n* No history of significant neurologic or cognitive disorders. Examples include neonatal anoxic encephalopathy, seizure disorders, autism, and most learning disorders including attention deficit hyperactivity disorder;\n* Able to provide assent. Parents will provide consent.\n* Able to speak and read English.\n\nEXCLUSION CRITERIA - SAMPLE 1:\n\nChild volunteers will be excluded for the following reasons:\n\n* Presence of any medical condition that increases risk for MRI (e.g., pacemaker, metallic foreign body in eye or other body part, dental braces);\n* Presence or history of medical conditions known to affect cerebral anatomy;\n* Children who are not pre-pubertal as indicated by the presence of Tanner stage 2 development (i.e., areolar development in girls and testicular volume \\> 3 cc in boys);\n* Individuals who have, or whose parent or guardians have, current substance abuse or a psychiatric disorder or any other condition which, in the opinion of the investigators, would impede the ability to give informed consent or possibly hinder completion of the study; presence of any psychiatric disorder in the subject, sibling, or other first-degree relative;\n* Subjects who regularly use prescription medications (the use of over-the-counter medications will be reviewed on a case-by-case basis.);\n* For females who have reached menarche: Pregnancy, lactation, or inability or unwillingness to undergo pregnancy testing (a urine pregnancy test will be performed prior to all MRI and X-ray procedures for girls who have had the onset of menses);\n* Current or past use of psychiatric medication;\n* I.Q. \\\u003C 70 (determined by the scores on Test of Irregular Word Reading Efficiency \\[TIWRE\\]).\n\nINCLUSION CRITERIA - SAMPLE 2:\n\nChild volunteers will qualify for inclusion if they meet the following criteria:\n\n* Good general health and normal IQ; A normal IQ will be determined by the scores on Test of Irregular Word Reading Efficiency (TIWRE)\n* Ages 12-13 years;\n* Body Mass Index (kg\u002Fm\\^2) between the 15th and 85th percentiles for age and sex according to the US Centers for Disease Control and Prevention 2000 growth charts;\n* A normal tempo of growth as determined by skeletal age within +\u002F- 1.64 standard deviations of chronologic age according to the Greulich and Pyle radiographic atlas (i.e., no evidence for precocious puberty or abnormal delay of maturation); Research criteria for determining bone age will be performed by the collaborating pediatric endocrinologist. This criterion is required only for the initial entry into this study and is not one of the inclusion criteria for subsequent visits.\n* No history of significant neurologic or cognitive disorders. Examples include neonatal anoxic encephalopathy, seizure disorders, autism, and most learning disorders including attention deficit hyperactivity disorder;\n* Able to provide assent. Parents will provide consent.\n* Able to speak and read English.\n\nEXCLUSION CRITERIA - SAMPLE 2:\n\nChild volunteers will be excluded for the following reasons:\n\n* Presence of any medical condition that increases risk for MRI (e.g., pacemaker, metallic foreign body in eye or other body part, dental braces);\n* Presence or history of medical conditions known to affect cerebral anatomy;\n* Individuals who have, or whose parent or guardians have, current substance abuse or a psychiatric disorder or any other condition which, in the opinion of the investigators, would impede the ability to give informed consent or possibly hinder completion of the study; presence of any psychiatric disorder in the subject, sibling, or other first-degree relative;\n* Subjects who regularly use prescription medications (the use of over-the-counter medications will be reviewed on a case-by-case basis.);\n* For females who have reached menarche: Pregnancy, lactation, or inability or unwillingness to undergo pregnancy testing (a urine pregnancy test will be performed prior to all MRI and X-ray procedures for girls who have had the onset of menses);\n* Current or past use of psychiatric medication;\n* I.Q. \\\u003C 70 (determined by the scores on Test of Irregular Word Reading Efficiency \\[TIWRE\\]).\n\nINCLUSION\u002FEXCLUSION CRITERIA - SAMPLE 3:\n\nInclusion and exclusion criteria for sample 3 will be identical as those for sample 2 with the exception that children between the ages of 8 and 17 will be included.\n\nINCLUSION\u002FEXCLUSION CRITERIA - SAMPLE 4:\n\nSample 4 participants will also be volunteering in Protocol #95-M-0150 \"Neurobiological Investigation of Patients with Schizophrenia Spectrum Disorders and Their Siblings,\" and\u002For Protocol #81-M-0126, \"The Evaluation of Women with Menstrually-Regulated Mood and Behavioral Disorders,\" in which they will also have signed consent and through which they will have been screened.\n\nINCLUSION CRITERIA - SAMPLE 4:\n\n* Ages of 25 to 35 years at the time of enrollment.\n* Each subject must have a level of understanding sufficient to agree to all required tests and examinations and sign an informed consent document.\n* No use of psychotropic substances in the last 3 months.\n* No psychiatric or severe chronic medical illness at the time of the study, and by history.\n* Able to speak and read English.\n\nEXCLUSION CRITERIA - SAMPLE 4:\n\n* Presence of impaired hearing.\n* Pregnant or currently breast feeding. (a urine pregnancy test will be performed prior to MRI procedures in women).\n* Presence of a history head trauma with loss of consciousness in the last year or any evidence of functional impairment due to and persisting after head trauma.\n* Previous eye surgery with a prosthetic implant.\n* Participants with tattoos will be excluded if the tattoos are in a location on the body (eyes, lips, etc.) that could interfere with fMRI scans or contain a heavy metal content.\n* Presence of any non-organic implant or any other device such as: cardiac pacemaker, insulin infusion pump, implanted drug infusion device, cochlear, otologic, or ear implant, transdermal medication patch (Nitro), any metallic implants or objects, body piercing(s), bone\u002Fjoint pin, screw, nail, plate, wire sutures or surgical staples, shunt.\n* Presence of cerebral or other aneurysm clips.\n* Presence of shrapnel or other metal imbedded in the body (such as from war wounds or accidents).\n* Previous employment in metal fields or with machines that may have left any metallic fragments in or near the eyes.\n* History of a severe accident in the past that may possibly have left metal in the body.\n* Psychological contraindications for MRI (e.g., suffer from claustrophobia);\n* Less than an 8th grade education or an IQ below 70 as determined by the scores on Test of Irregular Word Reading Efficiency \\[TIWRE\\] .\n\nINCLUSION\u002FEXCLUSION CRITERIA - SAMPLE 5:\n\nInclusion and exclusion criteria for sample 5 will be identical as those for samples 1 and 2 (i.e., children will either be age 8-9 or between the ages of 12 and 13) with the exception that children with a tempo of growth that is considered abnormal as demonstrated by skeletal age greater than two standard deviations in advance of their chronologic age according to the Greulich and Pyle Radiographic Atlas will be included. These children will be matched for age, Tanner stage, race, ethnicity, and BMI with children currently enrolled in the longitudinal study.\n\nSAMPLE 6\n\nParticipants will have participated in this protocol as children in either Sample 1 or sample 2.\n\nINCLUSION CRITERIA:\n\n* Age 19 to 30 years at the time of re-enrollment.\n* Each subject must have a level of understanding sufficient to agree to all required tests and examinations and sign an informed consent document.\n* Normal physical exam, routine labs and absence of axis 1 psychiatric illnesses as confirmed by a Structured Diagnostic Interview for DSM-5 (SCID).\n* No current use of psychotropic substances.\n\nEXCLUSION CRITERIA:\n\n* Presence of any implant or medical condition that increases risk for MRI (e.g., pacemaker, metallic foreign body in eye or other body part, dental braces);\n* Presence or history of medical conditions known to affect cerebral anatomy;\n* Individuals who have current substance abuse or a psychiatric disorder or any other condition which, in the opinion of the investigators, would impede the ability to give informed consent or possibly hinder completion of the study;\n* Current use of psychiatric medication or presence of any psychiatric disorder;\n* For females: pregnancy, lactation, or inability or unwillingness to undergo pregnancy testing (a urine pregnancy test will be performed prior to all MRI procedures);","7 Years","35 Years",{"count":177,"type":21},480,"Despite the clear importance of adolescence in the emergence of a number of disease states and processes, there is surprisingly little known about how the endocrine and metabolic events accompanying puberty in humans impact normal developmental neurobiology. Epidemiologic studies have identified sexual dimorphisms in the prevalence of several neuropsychiatric disorders, including depression, schizophrenia, and substance abuse. Many of these sex differences emerge during or shortly after puberty and are maintained until the 5th-6th decade of life. For example, the two-fold greater risk of unipolar depression in women compared with men does not appear until adolescence, and prior to puberty girls are not at increased risk relative to boys. Puberty is a structured, transitional process that can be influenced by both nutritional factors and environmental stressors; nonetheless, the variability in the timing and duration of puberty is largely determined by oligogenic inheritance. Basic neuroscience research has demonstrated that hormonal events accompanying puberty impact on many of the physiologic systems involved in the regulation of brain function (e.g., the appearance of new neurons in a brain-region specific pattern, neuronal remodeling, and the pruning of cortical connectivity). Additionally, not only does stress during puberty increase the risk of disturbances in affective adaptation during adulthood, but the events accompanying puberty modify stress responsivity (e.g., alterations in the duration and peak response of hypothalamic-pituitary-adrenal \\[HPA\\] axis hormones to stressors). Moreover, animal work has demonstrated that neural connectivity differs in a brain regional specific manner according to the stage of puberty (i.e., early versus late). In humans, puberty also occurs in stages, and although the endocrinology of puberty, surprisingly, has not been fully characterized with longitudinal data, studies have documented that the physical changes measured by Tanner stages I to V are accompanied by progressive increases in the secretions of both gonadal and adrenal steroids. Nonetheless, there remains considerable variability in the timing and duration of this otherwise highly structured reproductive transition.\n\nWe propose to perform a longitudinal, naturalistic study examining changes in brain structure and function, behavior, and stress responsivity in boys and girls across the pubertal transition. Because the pubertal transition is defined by a complex series of physiologic events that emerge sequentially over several years and involve changes in multiple endocrine and growth systems, and because there is also considerable variability in the timing of these events reflecting the influence of both genetic and environmental factors, puberty cannot by delineated by age of the participants as has been done in most imaging and other neurobiological studies of adolescence. The present study will formally bridge this gap by defining pubertal events per se in participants.\n\nParticipants will include healthy boys and girls whose pubertal status will be assessed, and in whom endocrine, metabolic, and brain imaging measures will be evaluated at eight - ten month intervals from age eight years (pre-puberty) until age 17 years (post-puberty). Reproductive endocrine, metabolic, and physical measures will be employed to characterize the stage and duration of pubertal development. Outcome measures will be derived via multimodal neuroimaging techniques, cognitive\u002Fbehavioral assessments, metabolic measurements, and evaluations of HPA axis function. Additionally, the impact of genetic variation on the developmental trajectory of these parameters (both reproductive and CNS) will be determined.\n\nThis cross-institute proposal will employ a multidisciplinary approach to evaluating the effects on CNS function of the process of puberty in both boys and girls. This work will not only serve to inform research on the mechanisms by which sexual dimorphisms in neuropsychiatric disorders develop, it will also have important implications for the prevention and treatment of these disorders.",[65],[70,181,182,71,72,73],"Normal Development","Puberty",{"date":42,"type":43},{"date":185,"type":43},"2011-11-23",{"name":49,"class":50},{"id":188,"slug":4,"hasResults":11,"nctId":189,"briefTitle":190,"officialTitle":190,"acronym":4,"eligibilityCriteria":191,"healthyVolunteers":57,"sex":16,"minAge":58,"maxAge":192,"enrollmentInfo":193,"targetDuration":4,"studyType":127,"phases":195,"briefSummary":196,"conditions":197,"keywords":198,"overallStatus":74,"whyStopped":4,"lastUpdateSubmitDate":40,"lastUpdatePostDateStruct":202,"startDateStruct":203,"completionDateStruct":204,"leadSponsor":206,"locationsCount":51},"100053254","NCT07686393","PET Imaging of Noradrenergic Transmission in the Brain","* INCLUSION CRITERIA:\n\n  1. Aged 18 years or older.\n  2. Must have undergone a screening assessment under protocol 01-M-0254, The Evaluation of Patients with Mood and Anxiety Disorders and Healthy Participants or 17M0181 Recruitment and Characterization of Healthy Research Volunteers for NIMH Intramural Studies.\n  3. Be healthy based on medical history, physical examination, and laboratory testing.\n  4. Able to understand and willingness to provide informed consent.\n  5. Willingness to complete all study procedures including MRI tests.\n  6. Have had their radial artery pulse checked for the presence of adequate ulnar collateral flow and the absence of any metal or foreign objects in both wrists.\n  7. Agree to adhere to the lifestyle considerations\n\nEXCLUSION CRITERIA:\n\nAn individual who meets any of the following criteria will be excluded from participation in this study:\n\n1. Clinically significant abnormalities on EKG or laboratory testing. This includes CBC and acute care panel (Na, K, Cl, CO2, creatinine, glucose, urea nitrogen).\n2. Recent exposure to radiation (i.e., PET from other research) that, when combined with this study, would be above the allowable limits.\n3. Inability to lie flat on camera bed for at least two hours, including claustrophobia and weight greater than the maximum for the scanner (500 lbs).\n4. HIV infection.\n5. Pregnancy or breastfeeding.\n6. Must not have substance use disorder or alcohol use disorder.\n7. Unable to travel to the NIH.\n8. Unable to have an MRI scan (e.g., because of pacemakers or other implanted electrical devices, brain stimulators, dental implants, aneurysm clips (metal clips on the wall of a large artery), metallic prostheses (including metal pins and rods, heart valves, and cochlear implants), permanent eyeliner, implanted delivery pumps, shrapnel fragments, or metal fragments in the eye.\n9. Taking medications reported to have significant binding to alpha-1 adrenoceptors, medications that that alter norepinephrine release, or medications that lower blood pressure including antihypertensives, diuretics, or phosphodiesterase-5(PDE-5) inhibitors (e.g. sildenafil, tadalafil, vardenafil) within five elimination halflives prior to any \\[11C\\]ARMI PET scan.\n10. Known hypersensitivity to quinazoline-class medications (e.g., prazosin), defined as any prior allergic or clinically significant adverse reaction requiring discontinuation or medical evaluation.\n11. Blood donation within 8 weeks (2 months) before study participation, or unwillingness to avoid blood donation for 8 weeks (2 months) after the study.","105 Years",{"count":194,"type":21},40,[155],"Background:\n\nResearchers have developed a new radioactive tracer (11C-ARMI). A tracer is a drug that attaches itself to other chemicals in the body and lights up so that the chemicals can be seen in imaging scans. The new tracer may be able to help them with many diseases, such as Alzheimer s disease and Parkinson s disease. Researchers want to test the new tracer in healthy people.\n\nObjective:\n\nTo test a new tracer (11C-ARMI) during imaging scans of the brain and body in healthy people.\n\nEligibility:\n\nHealthy people aged 18 years and older. They must have been screened under protocols 01-M-0254 or 17M0181.\n\nDesign:\n\nAll participants will have a positron emission tomography (PET)\u002Fcomputed tomography (CT) scan. Before the scan, they will have blood and urine tests and a test of their heart function. The tracer will be given through a tube attached to a needle inserted into a vein in the arm. They will lie on a padded bed that fits inside a doughnut-shaped machine; the machine uses x-rays to create images of the inside of the body.\n\nSome participants will have a PET\u002FCT scan of their whole body. They will need only 1 visit.\n\nSome participants will have a PET\u002FCT scan of only their brain. They will have up to 2 visits. On the second visit, they will have a magnetic resonance imaging (MRI) scan of the brain. For the MRI, they will lie on a table that slides into a cylinder. The MRI uses magnetic fields to create images of the inside of the body.\n\nParticipants will receive a follow-up call to check on their well-being after their PET\u002FCT scans.",[160],[199,200,201,160],"Positron Emission Tomography (PET) Imaging","11C-ARMI","Alpha-1A Adrenoreceptor ( 1A-AR)",{"date":42,"type":43},{"date":45,"type":21},{"date":205,"type":21},"2030-02-20",{"name":49,"class":50},{"id":208,"slug":4,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":209,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":23,"conditions":210,"keywords":211,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":212,"lastUpdatePostDateStruct":213,"startDateStruct":215,"completionDateStruct":217,"leadSponsor":218,"locationsCount":51},"100641449",{"count":20,"type":21},[25,26,27,28],[25,30,31,32,33,34,35,36,37,38],"2026-07-01",{"date":214,"type":43},"2026-07-02",{"date":216,"type":21},"2026-07-07",{"date":47,"type":21},{"name":49,"class":50},{"id":220,"slug":4,"hasResults":11,"nctId":221,"briefTitle":222,"officialTitle":222,"acronym":4,"eligibilityCriteria":223,"healthyVolunteers":57,"sex":16,"minAge":58,"maxAge":224,"enrollmentInfo":225,"targetDuration":4,"studyType":127,"phases":226,"briefSummary":227,"conditions":228,"keywords":229,"overallStatus":74,"whyStopped":4,"lastUpdateSubmitDate":212,"lastUpdatePostDateStruct":231,"startDateStruct":232,"completionDateStruct":233,"leadSponsor":235,"locationsCount":51},"100642123","NCT07625345","Evaluation of [11C]ZTP-1 to Image PDE4B","* INCLUSION CRITERIA:\n\nTo be eligible to participate in this study, an individual must meet the following criteria:\n\n* Aged 18 years or older.\n* Must have undergone a screening assessment under protocol 01M-0254, \"The Evaluation of Patients with Mood and Anxiety Disorders and Healthy Participants or protocol 17M0181 Recruitment and Characterization of Healthy Research Volunteers for NIMH Intramural Studies.\"\n* Be healthy based on medical history, physical examination, and laboratory testing.\n* Able to provide informed consent.\n* Willingness to complete all study procedures including MRI tests.\n* Have had their radial artery pulse checked for the presence of adequate ulnar collateral flow and the absence of any metal or foreign objects in both wrists.\n* Agree to adhere to the lifestyle considerations\n\nEXCLUSION CRITERIA:\n\nAn individual who meets any of the following criteria will be excluded from participation in this study:\n\n* Clinically significant abnormalities on EKG or laboratory testing. This includes CBC and acute care panel (Na, K, Cl, CO2, creatinine, glucose, urea nitrogen).\n* History of neurologic illness or injury with the potential to affect study data interpretation.\n* History of seizures, other than in childhood and related to fever.\n* Recent exposure to radiation (i.e., PET from other research) that, when combined with this study, would be above the allowable limits.\n* Inability to lie flat on camera bed for at least two hours, including claustrophobia and weight greater than the maximum for the scanner (500 lbs).\n* HIV infection.\n* Pregnancy or breastfeeding.\n* Must not have substance use disorder or alcohol use disorder.\n* Unable to travel to the NIH.\n* Unable to have an MRI scan (e.g., because of pacemakers or other implanted electrical devices, brain stimulators, dental implants, aneurysm clips (metal clips on the wall of a large artery), metallic prostheses (including metal pins and rods, heart valves, and cochlear implants), permanent eyeliner, implanted delivery pumps, shrapnel fragments, or metal fragments in the eye.\n* Known hypersensitivity to phosphodiesterase-4 (PDE-4) inhibitors (e.g. apremilast, roflumilast, nerandomilast, crisborole).\n* Taking CYP3A4 inhibitors (e.g. grapefruit juice, clarithromycin, erythromycin, ritonavir); CYP3A4 inducers (e.g. phenobarbital St. John's Wort, rifampicin) or oral contraceptives containing gestodene and ethinyl estradiol.\n\nEXCLUSION OF CHILDREN:\n\nInclusion of children is not appropriate, because this protocol has more than minimal risk from radiation exposure without the possibility of direct benefit.\n\nEXCLUSION OF PREGNANT OR BREASTFEEDING WOMEN:\n\nPregnant women will be excluded because this protocol involves exposure to ionizing radiation. Lactating women will be excluded because radioisotopes may be excreted in milk. We will perform a pregnancy test at screening and prior to all procedures to ensure participants are not pregnant. The test must be negative in order to continue on the study. In addition to completing a negative urine pregnancy test, on the day of PET scanning prior to PET scan procedures, participants of childbearing potential will undergo a clinical pregnancy screening interview with a licensed independent practitioner to confirm lack of pregnancy.\n\nEXCLUSION OF PARTICIPANTS WHO ARE HIV POSITIVE:\n\nPersons with HIV infection are excluded because HIV infection itself may change cAMP signaling.","101 Years",{"count":194,"type":21},[155],"Background:\n\nPDE4B is a protein in cells that helps turn off certain chemical signals after they ve done their job. It controls inflammation, immune responses, and some brain signaling. Measuring PDE4B levels in the body can help doctors manage a disease or know if a treatment is working. Researchers want to find out if a new tracer (a radioactive substance injected during imaging scans) can help them measure PDE4B in people more effectively.\n\nObjective:\n\nTo test a new tracer (\\[11C\\]ZTP-1) during imaging scans of the brain and body in healthy people.\n\nEligibility:\n\nHealthy people aged 18 and older. They must have been screened under protocols 01M-0254 or 17M0181.\n\nDesign:\n\nParticipants will have either 1 or 2 clinic visits.\n\nDuring their first visit, all participants will have a positron emission tomography (PET)\u002Fcomputed tomography (CT) scan. Prior to the scan, they will have blood and urine tests and a test of their heart function. The study tracer will be given through a tube attached to a needle inserted into a vein in the arm. They will lie on a padded bed that fits inside a doughnut-shaped machine; the machine uses x-rays to create images of the inside of the body.\n\nSome participants will have a PET\u002FCT scan of their whole body. They will need only 1 visit. The visit will last up to about 8 hours.\n\nSome participants will have a PET\u002FCT scan of only their brain. They will also have a magnetic resonance imaging (MRI) scan of the brain. They may need to return for a second visit for the MRI scan.\n\nParticipants will receive a follow-up call to check on their well-being after their PET\u002FCT scans.",[160],[163,230],"11C-ZTP-1",{"date":214,"type":43},{"date":216,"type":21},{"date":234,"type":21},"2030-10-03",{"name":49,"class":50},{"id":237,"slug":4,"hasResults":11,"nctId":81,"briefTitle":82,"officialTitle":82,"acronym":4,"eligibilityCriteria":83,"healthyVolunteers":11,"sex":16,"minAge":84,"maxAge":18,"enrollmentInfo":238,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":87,"conditions":239,"keywords":240,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":212,"lastUpdatePostDateStruct":241,"startDateStruct":242,"completionDateStruct":243,"leadSponsor":244,"locationsCount":51},"100636498",{"count":86,"type":21},[89,90,72],[92,93,65],{"date":214,"type":43},{"date":216,"type":21},{"date":97,"type":21},{"name":49,"class":50},{"id":246,"slug":4,"hasResults":11,"nctId":147,"briefTitle":148,"officialTitle":149,"acronym":4,"eligibilityCriteria":150,"healthyVolunteers":57,"sex":16,"minAge":151,"maxAge":59,"enrollmentInfo":247,"targetDuration":4,"studyType":127,"phases":248,"briefSummary":156,"conditions":249,"keywords":250,"overallStatus":74,"whyStopped":4,"lastUpdateSubmitDate":212,"lastUpdatePostDateStruct":251,"startDateStruct":252,"completionDateStruct":253,"leadSponsor":254,"locationsCount":51},"100605983",{"count":153,"type":21},[155],[158,159,160],[162,163],{"date":214,"type":43},{"date":216,"type":21},{"date":167,"type":21},{"name":49,"class":50},{"id":256,"slug":4,"hasResults":11,"nctId":257,"briefTitle":258,"officialTitle":258,"acronym":4,"eligibilityCriteria":259,"healthyVolunteers":57,"sex":16,"minAge":58,"maxAge":260,"enrollmentInfo":261,"targetDuration":4,"studyType":127,"phases":263,"briefSummary":264,"conditions":265,"keywords":267,"overallStatus":74,"whyStopped":4,"lastUpdateSubmitDate":212,"lastUpdatePostDateStruct":269,"startDateStruct":270,"completionDateStruct":272,"leadSponsor":274,"locationsCount":51},"100493325","NCT05703685","[18F]PF-06445974 to Image PDE4B in Major Depressive Disorder Using PET","* INCLUSION CRITERIA:\n\nPatients: In order to be eligible for this study, MDD participants must meet all of the following criteria:\n\n* 18 to 70 years of age.\n* Female participants of childbearing potential must be using a medically acceptable means of contraception.\n* Be in good general health as evidenced by medical history and physical examination. Stable medical conditions as assessed by their primary care provider (PCP) and\u002For in-house clinician are permitted to join the study.\n* Each participant must have a level of understanding sufficient to agree to all required tests and examinations and sign an informed consent document.\n* All participants must have undergone a screening assessment under protocol 01-M-0254, The Evaluation of Patients with Mood and Anxiety Disorders and Healthy Participants .\n* Participants must fulfill DSM-5 criteria for major depression (MDD) without psychotic features, as based on clinical assessment and structured diagnostic interview (SCID-P).\n* Participants must have an initial score on the MADRS \\>= 18 or HAM-D \\>= 15 within one week of study entry.\n* Participants must be experiencing an MDE lasting at least four weeks.\n* All MDD participants must have a PCP or psychiatrist in the community.\n* Participants must have their radial artery pulse checked for the presence of adequate ulnar collateral flow and the absence of any metal or foreign objects in both wrists.\n* Participants must agree to adhere to the lifestyle considerations.\n\nHealthy Controls: In order to be eligible to participate in this study, control subjects must meet all of the following criteria:\n\n* Aged 18 to 70 years old.\n* Female participants of childbearing potential must be using a medically acceptable means of contraception.\n* Able to provide informed consent.\n* Be in good general health, as evidenced by medical history and physical examination, and have no cognitive impairment.\n* Be enrolled in 01M0254, The Evaluation of Participants with Mood and Anxiety Disorders and Healthy Volunteers or 17M0181, Recruitment and Characterization of Healthy Research Volunteers for NIMH Intramural Studies .\n* Have their radial artery pulse checked for the presence of adequate ulnar collateral flow and the absence of any metal or foreign objects in both wrists.\n* Agree to adhere to the lifestyle considerations.\n\nEXCLUSION CRITERIA:\n\nParticipants with MDD who meet any of the following criteria will be excluded from participation in this study:\n\n* Clinically significant abnormalities on EKG or laboratory testing. This includes CBC and acute care panel (Na, K, Cl, CO2, creatinine, glucose, urea nitrogen). Any lab value that is two-times the upper limit or even lower values in the investigator s judgment. Creatinine level \\>1.3 mg\u002FdL.\n* Participants must be free of all prohibited medications for at least two weeks (5 weeks for aripiprazole, brexpiprazole, fluoxetine) prior to screen visit. These medications include antidepressants, antipsychotics, anxiolytics, psychotropic drugs not otherwise specified\n\n(including herbal products), and sedatives\u002Fhypnotics.\n\n* Current psychotic features, a diagnosis of schizophrenia or any other psychotic disorder as defined in the DSM-5.\n* Participants with a history of psychiatric inpatient hospitalization within the past year.\n* Participants with a history of DSM-5 substance use disorder (except for caffeine or nicotine dependence) within the preceding three months. In addition, participants must not have substance use disorder or alcohol use disorder. However, alcohol or cannabis use by themselves are not exclusion criteria, unless that use impairs function of daily life.\n* Participants who, in the investigator s judgment, pose a current serious suicidal or homicidal risk.\n* Participants with suicidal ideation within the past 6 months.\n* Participants with suicidal behavior within the past 12 months.\n* Participants who have a history of aggressive behavior towards others.\n* Participants who have an unstable medical condition that, in the opinion of the investigators, makes participation unsafe (e.g., an active infection or untreated malignancy).\n* HIV infection.\n* Pregnancy.\n* Are unable to travel to the NIH.\n* Have recent exposure to radiation related to research (e.g., PET from other research) that, when combined with this study, would be above the allowable limits.\n* Have an inability to lie flat and\u002For lie still on the camera bed for at least two hours, including claustrophobia, overweight greater than the maximum for the scanner, and uncontrollable behavioral symptoms, which will be screened by an interview with the participant during the screening visit.\n* Are unable to have an MRI scan (e.g., because of pacemakers or other implanted electrical devices, brain stimulators, dental implants, aneurysm clips (metal clips on the wall of a large artery), metallic prostheses (including metal pins and rods, heart valves, and cochlear implants), permanent eyeliner, implanted delivery pumps, shrapnel fragments, or metal fragments in the eye.\n* Be NIMH staff or an NIH employee who is a subordinate\u002Frelative\u002Fco-worker of the investigators.\n\nHealthy controls who meet any of the following criteria will be excluded from participation in this study:\n\n* Clinically significant abnormalities on EKG or laboratory testing. This includes CBC and acute care panel (Na, K, Cl, CO2, creatinine, glucose, urea nitrogen).\n* Participants must be free of all prohibited medications or at least two weeks (5 weeks for aripiprazole, brexpiprazole, fluoxetine) prior to screen visit. These medications include antidepressants, antipsychotics, anxiolytics, psychotropic drugs not otherwise specified (including herbal products), and sedatives\u002Fhypnotics.\n* Participants with a history of DSM-5 substance use disorder (except for caffeine or nicotine dependence) within the preceding three months. In addition, participants must not have substance use disorder or alcohol use disorder. However, alcohol or cannabis use by themselves are not exclusion criteria, unless that use impairs function of daily life.\n* Participants who have a history of major depressive disorder.\n* Participants who have an unstable medical condition that, in the opinion of the investigators, makes participation unsafe (e.g., an active infection or untreated malignancy).\n* HIV infection.\n* Pregnancy.\n* Are unable to travel to the NIH.\n* Have recent exposure to radiation related to research (e.g., PET from other research) that, when combined with this study, would be above the allowable limits.\n* Have an inability to lie flat and\u002For lie still on the camera bed for at least two hours, including claustrophobia, overweight greater than the maximum for the scanner, and uncontrollable behavioral symptoms, which will be screened by an interview with the participant during the screening visit.\n* Are unable to have an MRI scan (e.g., because of pacemakers or other implanted electrical devices, brain stimulators, dental implants, aneurysm clips (metal clips on the wall of a large artery), metallic prostheses (including metal pins and rods, heart valves, and cochlear implants), permanent eyeliner, implanted delivery pumps, shrapnel fragments, or metal fragments in the eye.\n* Use of cytochrome P450 enzyme inducers (e.g. rifampin, phenobarbital, carbamazepine, phenytoin).\n* Be NIMH staff or an NIH employee who is a subordinate\u002Frelative\u002Fco-worker of the investigator.","70 Years",{"count":262,"type":21},108,[155],"Background:\n\nMajor depressive disorder (MDD) is a psychiatric condition. People with MDD have occasional bouts of depressive symptoms; these bouts are called major depressive episodes (MDEs). Researchers want to know if people having MDEs have lower levels of an enzyme called PDE4B in their brains.\n\nPrimary Objective: To determine whether PDE4B is reduced in the brains of individuals with MDD experiencing a major depressive episode (MDE). Secondary Objectives: To determine the optimal length of scanning and the retest variability and reliability of \\[18F\\]PF-06445974, and whether PDE4B binding correlates with clinical rating scales. To measure if PDE4B radioligand binding can be blocked by taking apremilast.\n\nEligibility:\n\nPeople aged 18-70 years with MDD. Healthy volunteers are also needed.\n\nDesign:\n\nParticipants will have up to 5 clinic visits.\n\nParticipants will be screened. They will have a physical exam with blood tests. They will have a test of their heart function. Some participants may have a psychiatric assessment; they will answer questions about their state of mind and related topics.\n\nParticipants will have magnetic resonance imaging (MRI) of the brain. They will lie on a table that slides into a metal cylinder.\n\nParticipants will have a positron emission tomography (PET) scan. A needle will be used to guide a thin plastic tube (catheter) into a vein in one arm. An experimental substance called a radioactive tracer (\\[18F\\]PF-06445974) will be injected through the catheter. Participants will lie on a table that slides into a doughnut-shaped machine. The scan will last up to 4 hours with a 15-minute break.\n\nParticipants blood pressure, heart rate, and breathing will be monitored before, during, and after the PET scan. A second catheter will be inserted in the artery of the wrist so blood can be drawn during the scan.\n\nSome participants may return for a second PET scan; have a lung scan or receive apremilast.\n\nhttps:\u002F\u002Fnimhcontent.nimh.nih.gov\u002Fstart\u002Fsurveys\u002F?s=KE88DXXPLDFHHTF8",[266],"Depression",[163,266,268],"Phosphodiesterase-4",{"date":214,"type":43},{"date":271,"type":43},"2023-06-22",{"date":273,"type":21},"2029-04-11",{"name":49,"class":50},{"id":276,"slug":4,"hasResults":11,"nctId":277,"briefTitle":278,"officialTitle":278,"acronym":4,"eligibilityCriteria":279,"healthyVolunteers":57,"sex":16,"minAge":58,"maxAge":260,"enrollmentInfo":280,"targetDuration":4,"studyType":127,"phases":282,"briefSummary":283,"conditions":284,"keywords":285,"overallStatus":74,"whyStopped":4,"lastUpdateSubmitDate":212,"lastUpdatePostDateStruct":288,"startDateStruct":289,"completionDateStruct":291,"leadSponsor":292,"locationsCount":51},"100407245","NCT04582916","PET Imaging of Cyclooxygenase in Participants With Major Depressive Disorder (MDD)","* INCLUSION CRITERIA:\n\nPatients: In order to be eligible for this study, MDD participants must meet all of the following criteria:\n\n1. Aged 18 to 70 years old.\n2. Female participants of childbearing potential must be using a medically acceptable means of contraception.\n3. Participants must be in good general health as evidenced by medical history and physical examination.\n4. Each participant must have a level of understanding sufficient to agree to all required tests and examinations and sign an informed consent document.\n5. All participants must have undergone a screening assessment under protocol 01M0254, The Evaluation of Patients with Mood and Anxiety Disorders and Healthy Participants .\n6. Participants must fulfill DSM-5 criteria for major depression (MDD) without psychotic features, as based on clinical assessment and structured diagnostic interview (SCID-P).\n7. Participants must have an initial score on the MADRS greater than or equal to 18 or HAM-D greater than or equal to 15 within one week of study entry.\n8. Participants must be experiencing an MDE lasting at least four weeks.\n9. Unmedicated participants in both Groups must be medication-free for at least two weeks (5 weeks for aripirazole, brexpiprazole, fluoxetine) prior to first screen visit. Medications will not be discontinued for the purpose of this study.\n10. Participants must have their radial artery pulse checked for the presence of adequate ulnar collateral flow and the absence of any metal or foreign objects in both wrists.\n11. Participants must agree to adhere to the lifestyle considerations.\n\nHealthy Controls: In order to be eligible to participate in this study, control subjects must meet all of the following criteria:\n\n1. Aged 18 to 70 years old.\n2. Female participants of childbearing potential must be using a medically acceptable means of contraception.\n3. Able to provide informed consent.\n4. Be in good general health, as evidenced by medical history and physical examination, and have no cognitive impairment.\n5. Be enrolled in 01M0254, The Evaluation of Participants with Mood and Anxiety Disorders and Healthy Volunteers or 17M0181, Recruitment and Characterization of Healthy Research Volunteers for NIMH Intramural Studies .\n6. Have their radial artery pulse checked for the presence of adequate ulnar collateral flow and the absence of any metal or foreign objects in both wrists.\n7. Agree to adhere to the lifestyle considerations.\n\nEXCLUSION CRITERIA:\n\nParticipants with MDD who meet any of the following criteria will be excluded from participation in this study:\n\n1. Clinically significant abnormalities on EKG or laboratory testing. This includes CBC and acute care panel (Na, K, Cl, CO2, creatinine, glucose, urea nitrogen). Any lab value that is two-times the upper limit or even lower values in the investigator s judgment. Creatinine level \\>1.3 mg\u002FdL.\n2. Participants must be free of all prohibited medications or at least two weeks (5 weeks for aripiprazole, brexpiprazole, fluoxetine) prior to screen visit. These medications include antidepressants, anti-inflammatory drugs (except for study medication celecoxib), antipsychotics, anxiolytics, psychotropic drugs not otherwise specified (including herbal products), and sedatives\u002Fhypnotics. Medicated participants in Group B may continue their therapy.\n3. Participants should not have taken Non-Steroidal Anti-Inflammatory Drug (NSAID)s for two weeks prior to the PET scan. Aspirin, corticosteroids (with the exception of topical steroids), or immunosuppressants (e.g. methotrexate) must not have been taken in the prior month.\n4. Current psychotic features or a diagnosis of schizophrenia or any other psychotic disorder as defined in the DSM-5.\n5. Participants with a history of DSM-5 substance use disorder (except for caffeinei or nicotine dependence) within the preceding three months. In addition, participants must not have substance use disorder or alcohol use disorder. However, alcohol or cannabis use by themselves are not exclusion criteria, unless that use impairs function of daily lfe.\n6. Participants who, in the investigator s judgment, pose a current serious suicidal or homicidal risk.\n7. Participants who have a history of aggressive behavior towards others.\n8. Participants who have an unstable medical condition that, in the opinion of the investigators, makes participation unsafe (e.g., an active infection or untreated malignancy).\n9. Participants seeking treatment or a change in treatment and may be referred to the community or to another research study.\n10. Are unable to travel to the NIH.\n11. Have recent exposure to radiation related to research (e.g., PET from other research) that, when combined with this study, would be above the allowable limits.\n12. Have an inability to lie flat and\u002For lie still on the camera bed for at least two hours, including claustrophobia, overweight greater than the maximum for the scanner, and uncontrollable behavioral symptoms, which will be screened by an interview with the participant during the screening visit.\n13. Are unable to have an MRI scan (e.g., because of pacemakers or other implanted electrical devices, brain stimulators, dental implants, aneurysm clips (metal clips on the wall of a large artery), metallic prostheses (including metal pins and rods, heart valves, and cochlear implants), permanent eyeliner, implanted delivery pumps, shrapnel fragments, or metal fragments in the eye.\n14. Pregnancy.\n15. HIV Infection.\n16. Be NIMH staff or an NIH employee who is a subordinate\u002Frelative\u002Fco-worker of the investigators.\n\nHealthy controls who meet any of the following criteria will be excluded from participation in this study:\n\n1. Clinically significant abnormalities on EKG or laboratory testing. This includes CBC and acute care panel (Na, K, Cl, CO2, creatinine, glucose, urea nitrogen).\n2. Participants must be free of all prohibited medications or at least two weeks (5 weeks for aripiprazole, brexpiprazole, fluoxetine) prior to screen visit. These medications include antidepressants, anti-inflammatory drugs (except for study medication celecoxib), antipsychotics, anxiolytics, psychotropic drugs not otherwise specified (including herbal products), and sedatives\u002Fhypnotics.\n3. Participants should not have taken NSAIDs for two weeks prior to the PET scan. Aspirin, corticosteroids, or immunosuppressants (e.g. methotrexate) must not have been taken in the prior month.\n4. Participants with a history of DSM-5 substance use disorder (except for caffeine or nicotine dependence) within the preceding three months. In addition, participants must not have substance use disorder or alcohol use disorder. However, alcohol or cannabis use by themselves are not exclusion criteria, unless that use impairs function of daily life.\n5. Participants who have an unstable medical condition that, in the opinion of the investigators, makes participation unsafe (e.g., an active infection or untreated malignancy).\n6. Are unable to travel to the NIH.\n7. Have recent exposure to radiation related to research (e.g., PET from other research) that, when combined with this study, would be above the allowable limits.\n8. Have an inability to lie flat and\u002For lie still on the camera bed for at least two hours, including claustrophobia, overweight greater than the maximum for the scanner, and uncontrollable behavioral symptoms, which will be screened by an interview with the participant during the screening visit.\n9. Are unable to have an MRI scan (e.g., because of pacemakers or other implanted electrical devices, brain stimulators, dental implants, aneurysm clips (metal clips on the wall of a large artery), metallic prostheses (including metal pins and rods, heart valves, and cochlear implants), permanent eyeliner, implanted delivery pumps, shrapnel fragments, or metal fragments in the eye.\n10. Pregnancy.\n11. HIV Infection.\n12. Be NIMH staff or an NIH employee who is a subordinate\u002Frelative\u002Fco-worker of the investigators.\n\nEXCLUSION OF CHILDREN:\n\nBecause this protocol has more than minimal risk from radiation exposure without possibility of direct benefit, inclusion of children is not appropriate.\n\nEXCLUSION OF PREGNANT OR BREASTFEEDING WOMEN:\n\nPregnant women will be excluded because this protocol involves exposure to ionizing radiation. Lactating women will be excluded because radioisotopes may be excreted in milk.\n\nEXCLUSION OF PARTICIPANTS WHO ARE HIV POSITIVE:\n\nPersons with HIV infection are excluded because HIV infection itself may cause neuroinflammation, and we wish to specifically study the effect of depression on neuroinflammation.\n\nEXCLUSION OF NON ENGLISH SPEAKING PARTICIPANTS:\n\nNon-English-speaking participants will be excluded from participation in this study because neuropsychological testing is required by this protocol. This testing, which is critical for interpreting study results, has not been validated in other languages or when using a translator.",{"count":281,"type":21},64,[155],"Background:\n\nResearchers developed \\[11C\\]MC1, a radioligand for cyclooxygenase-2 (COX-2). COX-2 is an enzyme induced in the brain during inflammation. Researchers want to see the levels of COX-1 (measured as distribution volume VT) are elevated in the brain of two groups of mood disorders patients undergoing MDE relative to the control group.\n\nObjective:\n\nTo determine whether COX-1 and COX-2 are detectable in the brains of individuals with MDD experiencing a major depressive episode (MDE).\n\nEligibility:\n\nPeople aged 18-70 years with MDD and Healthy Volunteers aged 18 70 years.\n\nDesign:\n\nGroup A: MDD participants will be studied with the same dose of \\[11C\\]MC1 before and after administration of 600 mg celecoxib; the study is neither randomized nor placebo-controlled. Group B: MDD participants, both medicated and unmedicated, will be studied with \\[11C\\]PS13 and compared to healthy volunteers..\n\nhttps:\u002F\u002Fnimhcontent.nimh.nih.gov\u002Fstart\u002Fsurveys\u002F?s=TJW4RA4WN3LDD988",[266],[163,286,287,266],"Inflammation","Cyclooxygenase-2",{"date":214,"type":43},{"date":290,"type":43},"2021-07-20",{"date":167,"type":21},{"name":49,"class":50},{"id":294,"slug":4,"hasResults":11,"nctId":295,"briefTitle":296,"officialTitle":297,"acronym":4,"eligibilityCriteria":298,"healthyVolunteers":57,"sex":16,"minAge":58,"maxAge":299,"enrollmentInfo":300,"targetDuration":4,"studyType":127,"phases":302,"briefSummary":303,"conditions":304,"keywords":309,"overallStatus":74,"whyStopped":4,"lastUpdateSubmitDate":212,"lastUpdatePostDateStruct":312,"startDateStruct":313,"completionDateStruct":315,"leadSponsor":316,"locationsCount":51},"100392965","NCT04396873","PET Imaging of Cyclooxygenases in Neurodegenerative Brain Disease","Phase 1 Study: PET Imaging of Cyclooxygenases in Neurodegenerative Brain Disease","* INCLUSION CRITERIA:\n\nPatients: In order to be eligible to participate in this study, patients must meet all of the following criteria:\n\n1. Aged 18 or older.\n2. Be able (or have their Legally Authorized Representative (LAR) be able) to understand the study and be willing to sign a written informed consent document.\n3. Have been diagnosed by a neurologist or psychiatrist with MCI, ALS, PD, or an adult onset neurodegenerative dementia, such as AD (including amyloid negative subjects), FTD, corticobasal syndrome, or Huntington s disease.\n4. Be in good general health as evidenced by medical history and physical examination.\n5. Have their radial artery pulse checked for the presence of adequate ulnar collateral flow and the absence of any metal or foreign objects in both wrists.\n6. Agree to adhere to the lifestyle considerations.\n\nHealthy volunteers: In order to be eligible to participate in this study, healthy volunteer subjects must meet all of the following criteria:\n\n1. Aged 18 or older.\n2. Female participants of childbearing potential must be using a medically acceptable means of contraception\n3. Able provide informed consent.\n4. Be in good general health, as evidenced by medical history and physical examination, and have no cognitive impairment.\n5. Be enrolled in 01-M-0254, The Evaluation of Participants with Mood and Anxiety Disorders and Healthy Volunteers or 17-M-0181, Recruitment and Characterization of Healthy Research Volunteers for NIMH Intramural Studies\n6. Have their radial artery pulse checked for the presence of adequate ulnar collateral flow and the absence of any metal or foreign objects in both wrists.\n7. Agree to adhere to the lifestyle considerations.\n\nEXCLUSION CRITERIA:\n\nBoth patients and healthy volunteers who meet any of the following criteria will be excluded from participation in this study:\n\n1. Clinically significant abnormalities on EKG or laboratory testing. This includes CBC and acute care panel (Na, K, Cl, CO2, creatinine, glucose, urea nitrogen). Any lab value that is two-times the upper limit or even lower values in the investigator s judgment. Creatinine level \\>1.3 mg\u002FdL\n2. Subjects should not have taken Non-Steroidal Anti-Inflammatory Drugs (NSAID) for two weeks prior to the PET scan. Aspirin, corticosteroids (with the exception of skin products), or immunosuppressants (e.g., methotrexate) must not have been taken in the prior month.\n3. Contraindications to ketoprofen, such as hypersensitivity to ketoprofen or history of upper or lower gastrointestinal bleeding.\n4. Have other major neurological or medical diseases that may cause cognitive dysfunction, such as structural brain diseases, metabolic diseases, paraneoplastic syndromes, infectious diseases, or other significant neurological abnormalities.\n5. Have an unstable medical condition that, in the opinion of the investigators, makes participation unsafe (e.g., an active infection or untreated malignancy).\n6. Are unable to travel to the NIH.\n7. Have recent exposure to radiation related to research (e.g., PET from other research) that, when combined with this study, would be above the allowable limits.\n8. Have an inability to lie flat and\u002For lie still on the camera bed for at least two hours, including claustrophobia, overweight greater than the maximum for the scanner, and uncontrollable behavioral symptoms, which will be screened by an interview with the patient and\u002For caregiver during the screening visit.\n9. Participants must not have substance use disorder or alcohol use disorder. However, alcohol or cannabis use by themselves are not exclusion criteria, unless that use impairs function of daily life.\n10. Participants should not be under treatment with Aduhelm, nor should they have been treated in the past.\n11. Are unable to have an MRI scan (e.g., because of pacemakers or other implanted electrical devices, brain stimulators, dental implants, aneurysm clips (metal clips on the wall of a large artery), metallic prostheses (including metal pins and rods, heart valves, and cochlear implants), permanent eyeliner, implanted delivery pumps, shrapnel fragments, or metal fragments in the eye).\n12. Pregnancy\n13. HIV infection\n14. Be NIMH staff or an NIH employee who is a subordinate\u002Frelative\u002Fco-worker of the investigators.","99 Years",{"count":301,"type":21},184,[155],"Background:\n\nAbout 5 million adults in the U.S. have Alzheimer s disease or another adult-onset neurodegenerative disorder. Many studies have found that inflammation in the brain contributes to these diseases. Researchers want to find a better way to measure this inflammation.\n\nObjective:\n\nTo learn whether COX-1 and\u002For COX-2 is elevated in the brains of individuals with neurodegenerative brain disease compared to healthy volunteers.\n\nEligibility:\n\nAdults age 18 years and older in good general health who have an adult-onset neurodegenerative dementia, such as AD, FTD, corticobasal syndrome, Huntington s disease, or MCI, ALS and healthy adult volunteers enrolled in protocols 01-M-0254 or 17-M-0181.\n\nDesign:\n\nParticipants will be screened with medical history, physical exam with vital signs, and lab tests. They will have a neuropsychological testing. Their heart function will be measured.\n\nParticipants will have a magnetic resonance imaging (MRI) scan. The MRI scanner is a metal tube surrounded by a strong magnetic field. Participants will lie on a table that slides in and out of the tube. The machine makes noise. Participants will get earplugs.\n\nParticipants will have 2 PET scans. They will be injected with the study drugs through an intravenous catheter placed in an arm vein. The PET scanner is shaped like a doughnut. Participants will lie on a bed that slides in and out of the scanner. A plastic mask will be molded to their head to keep them from moving. A thin plastic tube will be put into an artery at the wrist or elbow crease area. This will be used to draw blood during the scan.\n\nParticipants will have 2-5 study visits. Participation lasts 1 week to 4 months, depending on scheduling.",[305,306,307,308,159],"Parkinson's Disease","Dementia","Alzheimer's Disease","ALS",[163,310,286,306,287,308,311],"PD","MCI",{"date":214,"type":43},{"date":314,"type":43},"2021-08-17",{"date":234,"type":21},{"name":49,"class":50},{"id":318,"slug":4,"hasResults":11,"nctId":319,"briefTitle":320,"officialTitle":321,"acronym":4,"eligibilityCriteria":322,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":323,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":325,"conditions":326,"keywords":327,"overallStatus":74,"whyStopped":4,"lastUpdateSubmitDate":212,"lastUpdatePostDateStruct":329,"startDateStruct":330,"completionDateStruct":332,"leadSponsor":334,"locationsCount":51},"100249912","NCT02531893","Psychological Treatments for Youth With Severe Irritability.","Psychological Treatments for Youth With Severe Irritability","* INCLUSION CRITERIA:\n\nInclusion criteria for both Interpretation Bias Training and Cognitive Behavioral Therapy Studies:\n\n1. Age 8-17 years\n2. Must be enrolled into NIMH DIRP protocol 02-M-0021, Characterization and Pathophysiology of Severe Mood and Behavioral Dysregulation in children and youth.\n3. Must meet DSM 5 diagnostic criteria for DMDD which are (for CBT, must meet lifetime history of either DMDD or one of two core DMDD criteria \\[b or c\\]):\n\n   * Must meet all of the following:\n\n     1. Diagnosis must first be made between ages 6-18 years\n     2. Abnormal mood (specifically, anger and\u002For irritability), present at least half of the day most days, and of sufficient severity to be noticeable by people in the child s environment (e.g. parents, teachers, peers).\n     3. Compared to his\u002Fher peers, the child exhibits markedly increased reactivity to negative emotional stimuli that is manifest verbally or behaviorally. For example, the child responds to frustration with extended temper tantrums (inappropriate for age and\u002For precipitating event), verbal rages, and\u002For aggression toward people or property. Such events occur, on average, at least three times a week.\n   * The symptoms in b and c above are currently present and have been present for at least 12 months without any symptom-free periods exceeding two months.\n   * The onset of symptoms must be prior to age 10 years.\n   * The symptoms are severe in at least one setting (e.g. violent outbursts, assaultiveness at home, school, or with peers). In addition, there are at least mild symptoms (verbal aggression) in a second setting.\n4. Patients must be fluent in English\n\n   1. All instruments have not been validated in other languages.\n   2. Psychotherapy will be designed and conducted in English.\n5. On the basis of record review and interviews with child and parent, the research team agrees that the child s response to his\u002Fher current treatment is no more than minimal (i.e. CGI-S of 3 or more).\n6. Must have no planned changes in outpatient psychiatric treatment regimen, which can include psychotropic medications and\u002For psychotherapeutic interventions, two weeks prior to enrollment and throughout the three weeks of training and post-training assessment.\n\nEXCLUSION CRITERIA:\n\nExclusion criteria both Interpretation Bias Training and Cognitive Behavioral Therapy Studies:\n\n1. The individual exhibits any of these cardinal bipolar symptoms:\n\n   1. Elevated or expansive mood.\n   2. Grandiosity or inflated self-esteem.\n   3. Decreased need for sleep.\n   4. Increase in goal-directed activity (this can result in the excessive involvement in pleasurable activities that have a high potential for painful consequences).\n   5. A history of hypomanic or manic symptoms that occurred in distinct episodes lasting more than 1 day.\n2. Meets DSM 5 criteria for schizophrenia, schizophreniform disorder, schizoaffective illness, Autism Spectrum Disorder, or posttraumatic stress disorder.\n3. IQ\\\u003C70\n4. The symptoms are due to the direct physiologic effects of a drug of abuse, or to a general medical or neurological condition.\n5. Meets criteria for alcohol or substance abuse three months prior to enrollment.\n6. Meets DSM 5 criteria for current major depressive disorder. The rationale for the exclusion of youth with MDD is because the two novel interventions being tested are contraindicated for those with major depressive disorder. However, there is no contraindication to participation for those with treated\u002Fresolved or remitted major depressive disorder; only those with a current diagnosis need to be excluded.",{"count":324,"type":21},200,"Background:\n\nWhen children have severe irritability and temper outbursts, they can be so cranky or angry that it leads to problems at home, in school, and with friends. This is called Disruptive Mood Dysregulation Disorder (DMDD) and there have been no psychological treatments developed specifically for children with this problem. Researchers think two forms of therapy, Cognitive Behavioral Therapy (CBT) and Interpretation Bias Training (IBT), might help children with DMDD.\n\nObjective:\n\nTo test two whether IBT and CBT can decrease severe irritability in children and youth.\n\nEligibility:\n\nChildren 8-17 years old with DMDD. Their symptoms must have started before age 10.\n\nDesign:\n\nParticipants will be screened with a review of their symptoms. Parents and participants will answer questions.\n\nParticipants can do only one or both of these treatments if they wish. Those who wish to do both will start with IBT.\n\nParticipants who do CBT will have 12-16 weekly meetings of research talk therapy. A parent will participate in part of the sessions.\n\nParticipants will talk about what makes them irritable and how it affects them. They may be put in situations that might make them annoyed or irritable.\n\nParticipants will rate how intense their irritability is. Parents and participants will complete rating scales, questionnaires, and interviews.\n\nParticipants will do practice activities at home.\n\nParticipants doing IBT will have up to 14 sessions over 10 weeks.\n\nParticipants will view 15 faces, one at a time, on a computer. They will choose if the face looks happy or angry on a computer. Sometimes the computer gives feedback. Participants will complete some sessions at the NIH and some at home.\n\nParticipants and parents answer questions about their progress.",[25],[328,36,33,71],"Interpretation Bias Training",{"date":214,"type":43},{"date":331,"type":43},"2015-11-17",{"date":333,"type":21},"2028-05-08",{"name":49,"class":50},{"id":336,"slug":4,"hasResults":11,"nctId":337,"briefTitle":338,"officialTitle":339,"acronym":4,"eligibilityCriteria":340,"healthyVolunteers":57,"sex":16,"minAge":58,"maxAge":341,"enrollmentInfo":342,"targetDuration":4,"studyType":127,"phases":344,"briefSummary":346,"conditions":347,"keywords":353,"overallStatus":74,"whyStopped":4,"lastUpdateSubmitDate":358,"lastUpdatePostDateStruct":359,"startDateStruct":361,"completionDateStruct":363,"leadSponsor":365,"locationsCount":51},"100490484","NCT05666726","State-dependent Interoception, Value-based Decision-making, and Introspection","State-Dependent Interoception, Value-Based Decision Making, and Introspection","* INCLUSION CRITERIA:\n\nSubject selections will be equitable among those individuals who meet the inclusion criteria. Every effort will be made to balance sex and race. In order to be eligible to participate in this study, an individual must meet all of the following criteria:\n\n* Ability of subject to understand and the willingness to sign a written informed consent document.\n* All sexes; Age 18 to 55.\n* Able to read and write in English to guarantee understanding of all written and spoken instructions, which are in English.\n\nEXCLUSION CRITERIA:\n\nAn individual who meets any of the following criteria will be excluded from participation in this study:\n\nFor all experiments:\n\n* Unable to comply with study procedures or follow-up visits\n* Has any serious or unstable medical condition or history that in a clinician s assessment implies a cardiovascular, neurological, or physical risk from the study procedures performed to induce negative valence states. This may include chronic systemic disorders that could worsen due to stress (e.g. uncontrolled hypertension, coronary artery disease for example a history of myocardial infarction or stable or unstable angina, or diabetes)\n* Has any current psychiatric diagnosis (based on SCID or the MINI Mini International Neuropsychiatric Interview) or no diagnosis but scores \\>=29 on Beck Depression Inventory II or \\>=26 on Beck Anxiety Inventory\n* Meets criteria for diagnosis of any substance-related or addictive disorder, or endorses any kind of problematic gambling behavior or problematic media-based addictive behavior (such as videogames, social-networking, online shopping, etc.)\n* Regular use of psychoactive medications or psychoactive substances\n* Regular use of corticosteroids\n* Is pregnant\n\nFor stress and pain induction:\n\n* Has a major medical condition or medical history that in a clinician s assessment could affect temperature sensitivity, pain thresholds, or ability to comply with study procedures. This may include cardiovascular, autonomic, neurological, psychiatric, or chronic systemic disorders (including but not limited to stroke, blindness, deafness, history of brain damage, neurodegenerative, neurotoxic or demyelinating disorder, or diabetes)\n* Has a medical condition that in a clinician s assessment might affect somatosensation (e.g., Raynaud s disease, peripheral neuropathy, or circulatory disorder)\n\nFor pain induction:\n\n* Has a current chronic pain condition or has had chronic pain in the past (painful condition lasting more than six months)\n* Has a dermatological condition such as scars or burns, or has had a tattoo in the testing region within the previous 4 weeks that might influence cutaneous sensibility\n* Regular and recent use of prescription or over-the-counter medication that has a significant effect on pain or heat perception. These include medications such as centralacting agents such as opiates (morphine, tramadol), antidepressants (amitriptyline, duloxetine, milnacipran), anticonvulsants (gabapentin, pregabalin), anxiolytics (barbiturates, benzodiazepines), hypnotics (zolpidem, sodium oxybate), antipsychotics (valproate, lithium, olanzapine), antimigraine agents (sumatriptan, ergotamine), and muscle relaxants (cyclobenzaprine, carisoprodol). Use of analgesic medications, such as non-steroidal anti-inflammatories, salicylates, and acetaminophen, taken on an as needed basis is acceptable as long as the last dose taken was within 5 half-lives of testing.\n\nFor craving induction:\n\n* Has a condition that in a clinician s assessment could preclude the ability to hold 4-6 hours of fasting or that is associated with a risk of hypoglycemia (such as diabetes, kidney disease, insulinoma, adrenal or pituitary tumors or disorders, or anorexia nervosa)\n* Is currently engaged in any kind of diet medically- or self-prescribed or endorses a very strong desire to start a diet that involves eliminating or decreasing carbohydrate consumption\n* Has a history of food allergies such as tree-nut or peanut allergy.\n\nFor fMRI experiments:\n\n* Individuals with conditions that could pose a risk relating to the safety of the fMRI procedure but do not meet specific exclusion criteria for all experiments or for specific inductions will be excluded from the MRI portion of the protocol but may participate in the non-MRI sessions. Such conditions include:\n* Those with ferromagnetic metal in the cranial cavity or eye (e.g. aneurysm clip, implanted neural stimulator, cochlear implant, ocular foreign body)\n* Those with an abnormality on a structural MRI\n* Those with an implanted cardiac pacemaker or auto-defibrillator\n* Those with an insulin pump\n* Those with an irremovable body piercing\n* Pregnancy (based on urine test completed within 24 hours prior to scan)\n* Left-handed (only for fMRI experiments involving thermal pain stimulation)","55 Years",{"count":343,"type":21},900,[345],"NA","Background:\n\nNegative emotional states can affect a person s behavior as they make decisions. For example, hunger may make people more impatient; they may then make riskier choices. Other negative emotional states that can change behavior include stress, pain, and sadness. By learning more about how emotions affect thinking and behavior in healthy people, researchers hope to better understand how to identify and treat people with mental disorders.\n\nObjective:\n\nTo learn how negative emotions affect the brain and decision-making behavior.\n\nEligibility:\n\nHealthy people aged 18 to 55 years.\n\nDesign:\n\nParticipants will have 3 clinic visits in 3 weeks.\n\nParticipants will fill out questionnaires. They will be asked about their personal history, their personality, and state of mind.\n\nFor 2 visits, participants will be assigned to different groups. Each group will experience 1 type of emotional stressor:\n\nSome participants will watch a video.\n\nSome will have to do arithmetic problems.\n\nSome will have heat applied to an arm or leg.\n\nSome will experience cold by immersing their hand in ice water.\n\nFor a snack craving test, some will be tempted by food after a 4-hour fast.\n\nDuring these tests, participants will have sensors attached to their bodies. They will be videotaped. Saliva samples will be collected.\n\nAfter the stressors, participants will do tasks on a computer. They will need to make choices.\n\nSome participants will perform these decision-making tasks while lying in a brain scanner for functional magnetic resonance imaging. The brain scan involves lying on a table that slides into a cylinder that takes images of the brain.\n\n...",[348,349,350,351,352],"Stress","Pain","Emotions","Craving","Frustration",[354,355,356,348,349,357],"Decision-Making","Interoception","Metacognition","Negative Emotion","2026-06-27",{"date":360,"type":43},"2026-06-30",{"date":362,"type":43},"2023-07-25",{"date":364,"type":21},"2029-12-31",{"name":49,"class":50},{"id":367,"slug":4,"hasResults":11,"nctId":368,"briefTitle":369,"officialTitle":370,"acronym":4,"eligibilityCriteria":371,"healthyVolunteers":57,"sex":16,"minAge":58,"maxAge":260,"enrollmentInfo":372,"targetDuration":4,"studyType":127,"phases":374,"briefSummary":375,"conditions":376,"keywords":378,"overallStatus":74,"whyStopped":4,"lastUpdateSubmitDate":358,"lastUpdatePostDateStruct":383,"startDateStruct":384,"completionDateStruct":386,"leadSponsor":388,"locationsCount":51},"100250835","NCT02543983","Neurobiology of Suicide","The Neurobiology of Suicide","* INCLUSION CRITERIA:\n\nPhase I: Groups 1-3 and 5 (Patients)\n\n1. 18 to 70 years of age.\n2. A level of understanding sufficient to agree to all required tests and examinations, sign an informed consent document and verify understanding by a score \\>= 90% on the Baseline consent quiz\n3. Individuals who are able to get pregnant must be willing to remain sexually abstinent or use at least one form of effective birth control during participation in Phase I.\n4. Additional Criteria for Group 1 (Active Crisis): Agree to be hospitalized\n\nPhase I: Group 4 (Healthy Volunteers)\n\n1. 18 to 70 years of age.\n2. A level of understanding sufficient to agree to all required tests and examinations, sign an informed consent document.\n3. Individuals who are able to get pregnant must be willing to remain sexually abstinent or use at least one form of effective birth control during participation in Phase I.\n\nPhase II: Group 1 (Active Crisis) and Group 5 (Suicide Ideators)\n\n1. Patients must have completed Study Phase I as a participant in Group 1 or 5\n2. Participants must verify understanding of the protocol by a score \\>= 80% on the Ketamine Response consent quiz.\n3. Patients in Group 1 or 5 must report at least minimal suicidal ideation, depressive or anxiety symptoms to be eligible for this phase.\n\n   * MADRS score of over 10 (10 used as an outcome measure for remission)126\n   * OR HAMA score of over 7 (7 used as an outcome measure for remission)127\n   * OR SSI score of 2 or more (indicates any residual suicidal thoughts)\n4. Individuals who are able to get pregnant must be willing to remain sexually abstinent or use at least one form of effective birth control during participation in Phase II.\n\nPhase III: Group 1 (Active Crisis) and Group 5 (Suicide Ideators)\n\n1. Participants must have met all inclusion criteria for and completed Study Phase II as a participant in Group 1 (active crisis) or Group 5 (Suicide Ideators).\n2. Individuals who are able to get pregnant must be willing to remain sexually abstinent or use at least one form of effective birth control during participation in Phase III.\n\nEXCLUSION CRITERIA:\n\nPhase I: Groups 1-3 and 5 (Patients)\n\n1. Current psychotic features or cognitive impairment that would preclude understanding of the consenting process or tests\u002Fexaminations.\n2. Current drug or alcohol dependence\n3. Currently intoxicated or under the acute effects of an illicit substance will not be consented into the study.\n4. Pregnant or nursing individuals or those who plan to become pregnant.\n5. Serious, unstable medical conditions\u002Fproblems including hepatic, renal, gastroenterologic, respiratory, cardiovascular (including blood pressure, ischemic heart disease), endocrinologic, neurologic, immunologic, or hematologic disease.\n6. Clinically significant abnormal laboratory tests.\n7. Positive HIV test\n8. Participants who, in the investigator s judgment, pose a current homicidal risk or pose suicide risk that cannot be managed in a secure, voluntary inpatient setting.\n9. Non-English speakers\n10. Additional Criteria for Group 1 (Active Crisis): For participants who still experience the effects of their suicide attempt, i.e. someone who overdosed is significantly drowsy or confused, the consenting process will occur after the patient has improved from the effects. If there is a concern around a participant's capacity to consent, the Human Subjects Protections Unit (HSPU) team member who is\n\nmonitoring the informed consent process will complete a capacity assessment. Participants who are determined not to have capacity to consent to research will not be included in the study.\n\nPhase I: Group 4 (Healthy Volunteers)\n\n1. Current or past Axis I diagnosis\n2. Presence of medical illness likely to alter brain morphology and\u002For physiology (e.g., hypertension, diabetes) even if controlled by medications.\n3. Current or past alcohol or substance abuse or dependence diagnosis (except for nicotine or caffeine) (or \"substance abuse disorder\" per DSM-V).\n4. Presence of psychiatric disorders or a history of suicide attempt or death in first-degree relatives.\n5. Pregnant or nursing individuals or those who plan to become pregnant.\n6. No lifetime suicide attempts or ideations\n7. Non-English speakers\n8. Positive HIV test\n\nExclusions for Imaging:\n\n1. Participants with metal objects implanted in the body, such as aneurysm clips, neural stimulators, implanted cardiac pacemakers, or auto-defibrillator, cochlear implant, or ocular foreign body which would make having an MRI scan unsafe\n2. Participants who are uncomfortable in small closed spaces (have claustrophobia) and would feel uncomfortable in the MRI machine\n3. Participants with a brain abnormality on an initial MRI scan\n4. Subjects with hearing loss that has been clinically evaluated and diagnosed and may be worsened through participation in imaging procedures\n\nPhase II: Group 1 (Active Crisis) and Group 5 (Suicide Ideators)\n\n1. Treatment with a reversible MAOI within 2 weeks prior to study Phase II.\n2. Treatment with any other concomitant medication not allowed within 5 1\u002F2 half-lives prior to study Phase II.\n3. Subjects with one or more seizures without a clear and resolved etiology\n4. Participants with a positive urine for an illicit substance no more than 24 hours prior to the ketamine infusion.\n5. Presence of current psychotic features or a diagnosis of Schizophrenia or any other psychotic disorder as defined in the DSM-IV or DSM-V\n6. Pregnant or nursing individuals or those who plan to become pregnant.\n7. A medical finding or condition that in the clinical judgement of the investigator increases the risk of adverse effects from the ketamine administration (for example: findings suggesting difficulties with kidney or cardiac function that may be contraindications for an experimental intervention).\n\nPhase III: Repeated Administration (Group 1) and Group 5 (Suicide Ideators)\n\n1. Intolerable or serious adverse reaction to ketamine during Phase II\n2. Treatment with a reversible MAOI within 2 weeks prior to study Phase III.\n3. Treatment with any other concomitant medication not allowed within 5 1\u002F2 half-lives prior to study Phase III.\n4. Subjects with one or more seizures without a clear and resolved etiology\n5. Participants with a positive urine for an illicit substance no more than 24 hours prior to each ketamine infusion.\n6. Presence of current psychotic features or a diagnosis of Schizophrenia or any other psychotic disorder as defined in the DSM-IV or DSM-V\n7. Pregnant or nursing individuals or those who plan to become pregnant.\n\nExclusions for Imaging:\n\n1. Participants with metal objects implanted in the body, such as aneurysm clips, neural stimulators, implanted cardiac pacemakers, or auto-defibrillator, cochlear implant, or ocular foreign body which would make having an MRI scan unsafe\n2. Participants who are uncomfortable in small closed spaces (have claustrophobia) and would feel uncomfortable in the MRI machine\n3. Participants with a brain abnormality on an initial MRI scan\n4. Subjects with hearing loss that has been clinically evaluated and diagnosed and may be worsened through participation in imaging procedures",{"count":373,"type":21},325,[129],"Background:\n\nThere are no good treatments for people considering suicide. Researchers want to study suicide with questions, blood tests, brain imaging, and sleep studies. They hope to better understand suicide, so they can help suicidal people.\n\nObjective:\n\nTo understand what happens in the brain when someone has thought about or attempted suicide.\n\nEligibility:\n\nGroup 1: Adults ages 18 70 who have thought about or attempted suicide recently\n\nGroup 2: Adults ages 18 70 who have thought about or attempted suicide in the past\n\nGroup 3: Adults ages 18 70 who have depression or anxiety, but have never thought about suicide\n\nGroup 4: Healthy volunteers the same ages.\n\nDesign:\n\nParticipants will be screened in another protocol. Adults who have recently thought about or attempted suicide must be referred by a doctor. They may do up to 3 phases of this study. Groups 2, 3 and 4 will do only Phase 1 and will not get ketamine.\n\nPhase 1: 1 week in hospital. Participants will have:\n\nPhysical exam.\n\nQuestions about thoughts and feelings.\n\nThinking and memory tests and simple tasks.\n\nBlood and urine tests.\n\nTwo MRI scans. Participants will lie on a table that slides into a metal cylinder that takes pictures. They will have a coil over their head and earplugs and do a computer task.\n\nSleep test. Disks and bands will be placed on the body to monitor it during sleep.\n\nMagnetic detectors on their head while they perform tasks.\n\nA wrist monitor for activity and sleep.\n\nLumbar puncture (optional). A needle will collect fluid from the back.\n\nShock experiments (optional). Participants will observe pictures and sounds and feel a small shock on the hand.\n\nPhase 2: 4 days in hospital. A thin plastic tube will be placed in each arm, one for blood draws, the other to get the drug ketamine once. Participants will repeat most of the Phase 1 tests.\n\nPhase 3: up to 4 more ketamine doses over 2 weeks.\n\nParticipants will have follow-up calls or visits at 6 months and then maybe yearly for 5 years.",[377,266],"Healthy Volunteers",[379,380,381,133,382],"Neurobiology","Suicide","Ketamine","Biomarkers",{"date":360,"type":43},{"date":385,"type":43},"2015-12-01",{"date":387,"type":21},"2030-07-21",{"name":49,"class":50},{"id":390,"slug":4,"hasResults":11,"nctId":171,"briefTitle":172,"officialTitle":172,"acronym":4,"eligibilityCriteria":391,"healthyVolunteers":57,"sex":16,"minAge":174,"maxAge":175,"enrollmentInfo":392,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":178,"conditions":393,"keywords":394,"overallStatus":74,"whyStopped":4,"lastUpdateSubmitDate":358,"lastUpdatePostDateStruct":395,"startDateStruct":396,"completionDateStruct":4,"leadSponsor":397,"locationsCount":51},"100166021","* INCLUSION CRITERIA - SAMPLE 1:\n\nChild volunteers will qualify for inclusion if they meet the following criteria:\n\n* Good general health and normal IQ; A normal IQ will be determined by the scores on Test of Irregular Word Reading Efficiency (TIWRE)\n* Age 8 years;\n* Body Mass Index (kg\u002Fm\\^2) between the 15th and 85th percentiles for age and sex according to the US Centers for Disease Control and Prevention 2000 growth charts;\n* A normal tempo of growth as determined by skeletal age within +\u002F- 1.64 standard deviations of chronologic age according to the Greulich and Pyle radiographic atlas (i.e., no evidence for precocious puberty or abnormal delay of maturation); Research criteria for determining bone age will be performed by the collaborating pediatric endocrinologist. This criterion is required only for the initial entry into this study and is not one of the inclusion criteria for subsequent visits;\n* No history of significant neurologic or cognitive disorders. Examples include neonatal anoxic encephalopathy, seizure disorders, autism, and most learning disorders including attention deficit hyperactivity disorder;\n* Able to provide assent. Parents will provide consent.\n* Able to speak and read English.\n\nEXCLUSION CRITERIA - SAMPLE 1:\n\nChild volunteers will be excluded for the following reasons:\n\n* Presence of any medical condition that increases risk for MRI (e.g., pacemaker, metallic foreign body in eye or other body part, dental braces);\n* Presence or history of medical conditions known to affect cerebral anatomy;\n* Children who are not pre-pubertal as indicated by the presence of Tanner stage 2 development (i.e., areolar development in girls and testicular volume \\> 3 cc in boys);\n* Individuals who have, or whose parent or guardians have, current substance abuse or a psychiatric disorder or any other condition which, in the opinion of the investigators, would impede the ability to give informed consent or possibly hinder completion of the study; presence of any psychiatric disorder in the subject, sibling, or other first-degree relative;\n* Subjects who regularly use prescription medications (the use of over-the-counter medications will be reviewed on a case-by-case basis.);\n* For females who have reached menarche: Pregnancy, lactation, or inability or unwillingness to undergo pregnancy testing (a urine pregnancy test will be performed prior to all MRI and X-ray procedures for girls who have had the onset of menses);\n* Current or past use of psychiatric medication;\n* I.Q. \\\u003C 70 (determined by the scores on Test of Irregular Word Reading Efficiency \\[TIWRE\\]).\n\nINCLUSION CRITERIA - SAMPLE 2:\n\nChild volunteers will qualify for inclusion if they meet the following criteria:\n\n* Good general health and normal IQ; A normal IQ will be determined by the scores on Test of Irregular Word Reading Efficiency (TIWRE)\n* Ages 12-13 years;\n* Body Mass Index (kg\u002Fm\\^2) between the 15th and 85th percentiles for age and sex according to the US Centers for Disease Control and Prevention 2000 growth charts;\n* A normal tempo of growth as determined by skeletal age within +\u002F- 1.64 standard deviations of chronologic age according to the Greulich and Pyle radiographic atlas (i.e., no evidence for precocious puberty or abnormal delay of maturation); Research criteria for determining bone age will be performed by the collaborating pediatric endocrinologist. This criterion is required only for the initial entry into this study and is not one of the inclusion criteria for subsequent visits.;\n* No history of significant neurologic or cognitive disorders. Examples include neonatal anoxic encephalopathy, seizure disorders, autism, and most learning disorders including attention deficit hyperactivity disorder;\n* Able to provide assent. Parents will provide consent.\n* Able to speak and read English.\n\nEXCLUSION CRITERIA - SAMPLE 2:\n\nChild volunteers will be excluded for the following reasons:\n\n* Presence of any medical condition that increases risk for MRI (e.g., pacemaker, metallic foreign body in eye or other body part, dental braces);\n* Presence or history of medical conditions known to affect cerebral anatomy;\n* Individuals who have, or whose parent or guardians have, current substance abuse or a psychiatric disorder or any other condition which, in the opinion of the investigators, would impede the ability to give informed consent or possibly hinder completion of the study; presence of any psychiatric disorder in the subject, sibling, or other first-degree relative;\n* Subjects who regularly use prescription medications (the use of over-the-counter medications will be reviewed on a case-by-case basis.);\n* For females who have reached menarche: Pregnancy, lactation, or inability or unwillingness to undergo pregnancy testing (a urine pregnancy test will be performed prior to all MRI and X-ray procedures for girls who have had the onset of menses);\n* Current or past use of psychiatric medication;\n* I.Q. \\\u003C 70 (determined by the scores on Test of Irregular Word Reading Efficiency \\[TIWRE\\]).\n\nINCLUSION\u002FEXCLUSION CRITERIA - SAMPLE 3:\n\nInclusion and exclusion criteria for sample 3 will be identical as those for sample 2 with the exception that children between the ages of 8 and 17 will be included.\n\nINCLUSION\u002FEXCLUSION CRITERIA - SAMPLE 4:\n\nSample 4 participants will also be volunteering in Protocol #95-M-0150 Neurobiological Investigation of Patients with Schizophrenia Spectrum Disorders and Their Siblings, and\u002For Protocol #81-M-0126, The Evaluation of Women with Menstrually-Regulated Mood and Behavioral Disorders, in which they will also have signed consent and through which they will have been screened.\n\nINCLUSION CRITERIA - SAMPLE 4:\n\n* Ages of 25 to 35 years at the time of enrollment.\n* Each subject must have a level of understanding sufficient to agree to all required tests and examinations and sign an informed consent document.\n* No use of psychotropic substances in the last 3 months.\n* No psychiatric or severe chronic medical illness at the time of the study, and by history.\n* Able to speak and read English.\n\nEXCLUSION CRITERIA - SAMPLE 4:\n\n* Presence of impaired hearing.\n* Pregnant or currently breast feeding. (a urine pregnancy test will be performed prior to MRI procedures in women).\n* Presence of a history head trauma with loss of consciousness in the last year or any evidence of functional impairment due to and persisting after head trauma.\n* Previous eye surgery with a prosthetic implant.\n* Participants with tattoos will be excluded if the tattoos are in a location on the body (eyes, lips, etc.) that could interfere with fMRI scans or contain a heavy metal content.\n* Presence of any non-organic implant or any other device such as: cardiac pacemaker, insulin infusion pump, implanted drug infusion device, cochlear, otologic, or ear implant, transdermal medication patch (Nitro), any metallic implants or objects, body piercing(s), bone\u002Fjoint pin, screw, nail, plate, wire sutures or surgical staples, shunt.\n* Presence of cerebral or other aneurysm clips.\n* Presence of shrapnel or other metal imbedded in the body (such as from war wounds or accidents).\n* Previous employment in metal fields or with machines that may have left any metallic fragments in or near the eyes.\n* History of a severe accident in the past that may possibly have left metal in the body.\n* Psychological contraindications for MRI (e.g., suffer from claustrophobia);\n* Less than an 8th grade education or an IQ below 70 as determined by the scores on Test of Irregular Word Reading Efficiency \\[TIWRE\\] .\n\nINCLUSION\u002FEXCLUSION CRITERIA - SAMPLE 5:\n\nInclusion and exclusion criteria for sample 5 will be identical as those for samples 1 and 2 (i.e., children will either be age 8-9 or between the ages of 12 and 13) with the exception that children with a tempo of growth that is considered abnormal as demonstrated by skeletal age greater than two standard deviations in advance of their chronologic age according to the Greulich and Pyle Radiographic Atlas will be included. These children will be matched for age, Tanner stage, race, ethnicity, and BMI with children currently enrolled in the longitudinal study.\n\nSAMPLE 6\n\nParticipants will have participated in this protocol as children in either Sample 1 or sample 2.\n\nINCLUSION CRITERIA:\n\n* Age 19 to 30 years at the time of re-enrollment.\n* Each subject must have a level of understanding sufficient to agree to all required tests and examinations and sign an informed consent document.\n* Normal physical exam, routine labs and absence of axis 1 psychiatric illnesses as confirmed by a Structured Diagnostic Interview for DSM-5 (SCID).\n* No current use of psychotropic substances.\n\nEXCLUSION CRITERIA:\n\n* Presence of any implant or medical condition that increases risk for MRI (e.g., pacemaker, metallic foreign body in eye or other body part, dental braces);\n* Presence or history of medical conditions known to affect cerebral anatomy;\n* Individuals who have current substance abuse or a psychiatric disorder or any other condition which, in the opinion of the investigators, would impede the ability to give informed consent or possibly hinder completion of the study;\n* Current use of psychiatric medication or presence of any psychiatric disorder;\n* For females: pregnancy, lactation, or inability or unwillingness to undergo pregnancy testing (a urine pregnancy test will be performed prior to all MRI procedures);",{"count":177,"type":21},[65],[70,181,182,71,72,73],{"date":360,"type":43},{"date":185,"type":43},{"name":49,"class":50},{"id":399,"slug":4,"hasResults":11,"nctId":400,"briefTitle":401,"officialTitle":401,"acronym":4,"eligibilityCriteria":402,"healthyVolunteers":57,"sex":16,"minAge":58,"maxAge":105,"enrollmentInfo":403,"targetDuration":4,"studyType":127,"phases":404,"briefSummary":405,"conditions":406,"keywords":408,"overallStatus":74,"whyStopped":4,"lastUpdateSubmitDate":358,"lastUpdatePostDateStruct":413,"startDateStruct":414,"completionDateStruct":416,"leadSponsor":418,"locationsCount":51},"100153235","NCT01266577","Development of Magnetic Resonance Spectroscopic Imaging Techniques for Imaging Metabolites in Human Brain and Muscle","* INCLUSION CRITERIA:\n* 18-65 years of age\n* able to give written informed consent\n* healthy based on medical history and physical exam\n* enrolled in Protocol 01-M-0254 or Protocol 17-M-0181\n\nEXCLUSION CRITERIA:\n\n* Any current Axis 1 diagnosis\n* Clinically significant laboratory abnormalities\n* Positive HIV test\n* Metallic foreign bodies that would be affected by the magnetic resonance imaging (MRI) magnet, or fear of enclosed spaces likely to make the subject unable to undergo an MRI scan.\n* History of neurological illness or injury with the potential to affect study data interpretation, such as multiple sclerosis, Parkinson s disease, seizure disorder or traumatic brain injury\n* Inability to lie flat on camera bed for about two and a half hours\n* Pregnant or breastfeeding\n* Current substance use disorder based on DSM-5\n* NIMH employees and staff and their immediate family members will be excluded from the study per NIMH policy.",{"count":20,"type":21},[345],"Background:\n\n\\- Magnetic resonance imaging (MRI) is a widely used scanning technique to obtain images of the human body and evaluate activity in the brain. A particular MRI method called magnetic resonance spectroscopy (MRS) can be used to study brain chemistry as well, which may help researchers who are studying new treatments for psychiatric illnesses. Researchers are interested in improving current MRI and MRS techniques, as well as developing new MRI and MRS techniques to view and measure brain chemicals and brain activity.\n\nObjectives:\n\n\\- To implement, develop, and optimize brain chemistry imaging techniques using magnetic resonance imaging and magnetic resonance spectroscopy.\n\nEligibility:\n\n\\- Healthy individuals between 18 and 65 years of age.\n\nDesign:\n\n* This study will involve a screening visit and a scanning visit at the National Institutes of Health Clinical Center.\n* Participants will be screened with a full medical and physical examination, blood and urine tests, and neurological testing.\n* During the second visit, participants will have an MRI scan of the brain. (Participants who have received an MRI within the past year will not need to have a second one; the images of the previous scan will be used for this study.) All participants will then have an MRS scan using the same scanning equipment....",[407,72],"Brain Mapping",[409,410,115,411,412],"Brain Metabolism","Neurochemistry","Mental Illness","Magnetic Resonance Spectroscopy",{"date":360,"type":43},{"date":415,"type":43},"2011-01-27",{"date":417,"type":21},"2026-10-23",{"name":49,"class":50},{"id":420,"slug":4,"hasResults":11,"nctId":101,"briefTitle":102,"officialTitle":103,"acronym":4,"eligibilityCriteria":104,"healthyVolunteers":57,"sex":16,"minAge":58,"maxAge":105,"enrollmentInfo":421,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":108,"conditions":422,"keywords":423,"overallStatus":74,"whyStopped":4,"lastUpdateSubmitDate":358,"lastUpdatePostDateStruct":424,"startDateStruct":425,"completionDateStruct":4,"leadSponsor":426,"locationsCount":51},"100054408",{"count":107,"type":21},[72],[111,112,113,114,115,71],{"date":360,"type":43},{"date":118,"type":43},{"name":49,"class":50},{"id":428,"slug":4,"hasResults":11,"nctId":122,"briefTitle":123,"officialTitle":123,"acronym":4,"eligibilityCriteria":429,"healthyVolunteers":57,"sex":16,"minAge":17,"maxAge":105,"enrollmentInfo":430,"targetDuration":4,"studyType":127,"phases":431,"briefSummary":130,"conditions":432,"keywords":433,"overallStatus":74,"whyStopped":4,"lastUpdateSubmitDate":358,"lastUpdatePostDateStruct":434,"startDateStruct":435,"completionDateStruct":436,"leadSponsor":437,"locationsCount":144},"100059514","* INCLUSION CRITERIA:\n\nALL JUVENILE SUBJECTS\n\n* Age: 8-17 (subjects who consent as 17-year-olds but turn 18 during the course of the study will be eligible to complete all procedures completed by other subjects who consent as 17-year-olds but do not turn 18).\n* Consent: can give consent\u002Fassent (Parents will provide consent; minors will provide assent)\n* IQ: all subjects will have IQ\\>70 (Assessment relies on either a WASI or assessment by trained clinical staff during the subject s screening visit. Completion of required activities during the screening visit requires an IQ above 70.)\n* Language: all subjects will speak English (Tasks in this protocol have not been validated in languages other than English)\n\nALL ADULT SUBJECTS\n\n* Age: 18-65\n* Consent: can give consent\n* IQ: all subjects will have IQ\\>70 (Assessment relies on either a WASI or assessment by trained clinical staff during the subject s screening visit. Completion of required activities during the screening visit requires an IQ above 70.)\n* Language: all subjects will speak English (Tasks in this protocol have not been validated in languages other than English)\n\nALL SUBJECTS WITH AN ANXIETY DISORDER\n\n* Diagnosis: Current Diagnosis of OCD, Social Phobia, Separation Anxiety, Generalized Anxiety Disorder, or Panic Disorder (Based on K-SADS (juveniles) or SCID (adults))\n* Symptom Severity: Clinically significant, ongoing anxiety symptoms (This will be documented by clinician review with patients and their families during at least two visits with families.)\n* Clinical Impairment: Clinically significant, ongoing distress or impairment from anxiety (This will be documented by clinician review with patients and their families during at least two visits with families.)\n\nALL PREVIOUSLY ENROLLED ADOLESCENT PATIENTS, CHILD AND ADULT HEALTHY VOLUNTEERS, AND ALL HEALTHY VOLUNTEERS TURNED PATIENTS\n\n* Diagnosis: Current Diagnosis of OCD, Social Phobia, Separation Anxiety, Generalized Anxiety Disorder, or Panic Disorder; No current diagnosis (Based on K-SADS (juveniles) or SCID (adults))\n* Clinical Impairment (as applicable): Clinically significant, ongoing symptoms (This will be documented by clinician review with patients and their families during at least two visits with families.)\n* Symptom Severity (as applicable): Clinically significant, ongoing symptoms (This will be documented by clinician review with patients and their families during at least two visits with families.)\n\nEXCLUSION CRITERIA:\n\nALL SUBJECTS\n\n* Any serious medical condition or condition that interferes with fMRI or M\u002FEEG scanning, and for patients electing medication, any condition that increases risk of SSRI treatment. (All patients will complete a medical history. Healthy volunteer participants will be medication- free and have no current serious medical conditions, based on a review of their medical history. Subjects only will be excluded from the MRI portions of the study based on this exclusion criterion.)\n* Pregnancy (Subjects only will be excluded from the MRI portions of the study based on this exclusion criterion.)\n* Current use of any psychoactive substance; current suicidal ideation; current diagnosis of attention deficit hyperactivity disorder (ADHD) of sufficient severity to require pharmacotherapy. (These factors could complicate treatment with an SSRI. No subject on medication will be accepted into the trial. Subjects will not be taken off of medications to enter the trial.)\n* Current diagnoses, major depressive disorder (MDD), post-traumatic distress disorder, conduct disorder. (These factors may be affected by SSRI treatment, influencing ability to detect effects on anxiety\u002Fsymptoms of depression. Of note, subjects who present with a diagnosis of MDD will not be eligible for inclusion at the outset of the study. However, youth with anxiety disorders frequently develop MDD when followed over time. Subjects will be allowed to remain in the study if they develop these diagnoses after enrollment.)\n* Past or current history of mania, psychosis, or severe pervasive developmental disorder. (These factors may be affected by SSRI treatment, influencing ability to detect effects on anxiety\u002Fsymptoms of depression. Of note, subjects who present with a diagnosis of MDD will not be eligible for inclusion at the outset of the study. However, youth with anxiety disorders frequently develop MDD when followed over time. Subjects will be allowed to remain in the study if they develop these diagnoses after enrollment.)\n* Recent use of an SSRI with failure to respond or tolerate SSRI treatment at an adequate dose and duration. (This is designed to exclude subjects who have failed a trial of an SSRI for their current problem with anxiety. For previously enrolled participants, including patients and healthy volunteers, current use of an SSRI does not exclude participation from follow-up research tasks.)\n* History of any (excepting nicotine-related and cannabis-related) DSM5-defined moderate to severe substance use disorder (or DSM-IV-defined substance dependence).\n\nHEALTHY ADULT SUBJECTS\n\n-Any current psychiatric diagnosis (Assessment relies on SCID)",{"count":126,"type":21},[129],[132,133],[65,135,136,115,137],{"date":360,"type":43},{"date":140,"type":43},{"date":142,"type":21},{"name":49,"class":50},{"id":439,"slug":4,"hasResults":11,"nctId":440,"briefTitle":441,"officialTitle":441,"acronym":4,"eligibilityCriteria":442,"healthyVolunteers":11,"sex":16,"minAge":58,"maxAge":443,"enrollmentInfo":444,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":446,"conditions":447,"keywords":466,"overallStatus":74,"whyStopped":4,"lastUpdateSubmitDate":469,"lastUpdatePostDateStruct":470,"startDateStruct":472,"completionDateStruct":474,"leadSponsor":476,"locationsCount":51},"100551600","NCT06462196","Natural History of Depression, Bipolar Disorder and Suicide Risk","* INCLUSION CRITERIA:\n\nIn order to be eligible to participate in this study, an individual must meet all of the following criteria:\n\n* Signed consent for Protocol 01-M-0254: The Evaluation of Patients with Mood and Anxiety Disorders and Healthy Volunteers\n* Age 18 years or older\n* Able to provide informed consent\n* Able to read and write English\n\nEXCLUSION CRITERIA:\n\n* Unstable medical conditions in the opinion of the investigator that would preclude participation in outpatient or inpatient treatment.\n* Pregnancy\n* Participation in the Protocol 01-M-0254: The Evaluation of Patients with Mood and Anxiety Disorders and Healthy Volunteers, as a healthy volunteer.\n* Participants with a history of DSM-IV substance or alcohol abuse or dependence, or DSM-5 substance use disorder (except for caffeine, nicotine, or cannabis), or moderate to severe alcohol use disorder, within the preceding three months. In addition, participants who are currently using drugs (except for caffeine, nicotine, or cannabis) must not have used illicit substances or known drugs of abuse in the two weeks prior to consent and must have a negative drug urine test (except for prescribed benzodiazepines or stimulants) prior to enrolling in the study. Cannabis use is exclusionary if the use is daily, or if participants are unable to abstain during the study, or if function of daily life is impaired by use as determined by a clinician.","120 Years",{"count":445,"type":21},500,"Mood disorders, such as depression and bipolar disorder, are difficult to treat. One reason is that there are no objective ways to measure how these disorders affect the body and respond to different treatments. In this study, researchers want to perform tests on people undergoing clinical care for mood disorders. The purpose is to understand the experience of receiving treatment for depression, bipolar disorder, and suicide risk. We also hope that this study will help us to predict which medications will improve thoughts of suicide.\n\nPeople 18 years or older who are receiving treatment for depression, bipolar disorder, or suicide risk may take part in this study. Participants must have also been enrolled in protocol 01-M-0254.\n\nThis study will be conducted at the NIH Clinical Center in Bethesda, MD. The study typically lasts up to 12 weeks, but may last longer if a participant s treatment continues past that time.\n\nParticipants will have weekly interviews and questionnaires while they are being treated for their mood disorder. Other tests are optional and include psychological testing, blood draws, sleep tests, and imaging scans. These will be done at the start and the end of research participation.",[448,380,449,450,451,452,453,454,455,456,457,458,459,460,461,381,462,463,464,133,465],"Behavioral Symptoms","Self-Injurious Behavior","Sensory System Agents","Analgesics","Peripheral Nervous System Agents","Physiological Effects of Drugs","Anesthetics, Dissociative","Anesthetics, General","Anesthetics","Central Nervous System Depressants","Excitatory Amino Acid Antagonists","Excitatory Amino Acid Agents","Neurotransmitter Agents","Molecular Mechanisms of Pharmacological Action","Depression, Unipolar","Depressive Symptoms","Treatment Resistant Depression","Depression, Bipolar",[379,380,133,467,382,468,464],"Bipolar Disorder","Suicide Risk","2026-06-26",{"date":471,"type":43},"2026-06-29",{"date":473,"type":43},"2024-09-09",{"date":475,"type":21},"2030-06-01",{"name":49,"class":50},{"id":478,"slug":4,"hasResults":11,"nctId":479,"briefTitle":480,"officialTitle":481,"acronym":4,"eligibilityCriteria":482,"healthyVolunteers":11,"sex":16,"minAge":483,"maxAge":484,"enrollmentInfo":485,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":487,"conditions":488,"keywords":493,"overallStatus":74,"whyStopped":4,"lastUpdateSubmitDate":500,"lastUpdatePostDateStruct":501,"startDateStruct":503,"completionDateStruct":505,"leadSponsor":507,"locationsCount":51},"100410940","NCT04631042","Developing Brain, Impulsivity and Compulsivity","An Observational Study of the Developing Brain, Impulsivity and Compulsivity","* INCLUSION CRITERIA:\n\nIn order to be eligible to participate in this study, an individual must meet all of the following criteria:\n\n1. Stated willingness to comply with all study procedures and availability for the duration of the study.\n2. Must be between 6 and 80 years of age.\n3. Ability of participant to understand and the willingness to sign a written informed consent document.\n\nEXCLUSION CRITERIA:\n\nAn individual who meets any of the following criteria will be excluded from participation in this study:\n\n1. Cognitively not capable of performing study procedures or lack of capacity to provide informed consent. Indications of a lack of cognitive capacity could include a known full-scale IQ under 70, or a history from the screening interview that implies global intellectual disabilities (e.g., placement in a school for children with intellectual disability etc.)\n2. Very premature birth (i.e., birth before 32 weeks of gestational age).\n3. Any known brain abnormalities (e.g., tumor, periventricular leukomalacia, microcephaly) or history of medical conditions known to affect cerebral anatomy (e.g., epilepsy, history of stroke, head injury with a loss of consciousness of one hour or more).\n4. Psychotic disorders (including schizophrenia, psychosis not otherwise specified).\n5. Dementia, or other conditions that, in the opinion of the investigators, would impede compliance or possibly hinder completion of the study.\n6. Pregnant women.\n7. Any other medical or psychiatric condition that in the opinion of the PI may confound study data\u002Fassessments.\n\nAdditional exclusion criteria for optional MRI procedure:\n\n1\\. Individuals who are not able to receive an MRI (e.g., metal bioimplants, claustrophobia, inability to lie flat on their backs, pregnant women, and any other contraindications for MRI scanning according to the NMR Center MRI safety guidelines).","6 Years","80 Years",{"count":486,"type":21},1100,"Background:\n\nImpulsivity is acting 'without thinking.' Compulsivity is being overly inflexible. People vary in how impulsive or compulsive they are. Extreme versions of these behaviors play a role in mental disorders. Researchers want to study changes in the brain to learn more about these behaviors. Differences in genes may also play a role.\n\nObjective:\n\nTo learn about genetic \\& brain features that explain why levels of impulsivity and compulsivity vary across people.\n\nEligibility:\n\nPeople ages 6 - 80\n\nDesign:\n\nParticipants will be screened with a medical history and medical record review.\n\nParticipants will talk about their mental and behavioral development. They may discuss topics like drug use and sexual activity. They will complete surveys about their compulsivity and impulsivity. Parents of child participants may also complete these surveys.\n\nParticipants may take memory, attention, and thinking tests. They may give blood or saliva samples for gene studies and they may give blood to make induced pluripotent stem cells. Participants may have their face and irises photographs taken.\n\nParticipants may have a magnetic resonance imaging scan. It will take pictures of their brain. The scanner is shaped like a cylinder. Participants will lie on a table that slides in and out of the scanner. A coil will be placed over their head. They will lie still, watch a movie, and play a game.\n\nParticipants may ask family members to join the study. Researchers are particularly interested in recruiting twin pairs to the study.\n\nParticipants under age 25 may repeat these tests every 1-2 years until they turn 25 or until the study ends. For those over age 25, participation will last less than 1 month.",[489,490,491,28,492],"Typical Development","Obsessive Compulsive Disorder","Conduct Disorder","Autism Spectrum Disorder",[494,495,71,496,497,498,499],"Neurodevelopmental disorder","Twin","Heritability","Glutamate","developmental trajectory","Brain Connectivity","2026-06-24",{"date":502,"type":43},"2026-06-25",{"date":504,"type":43},"2022-09-30",{"date":506,"type":21},"2031-12-31",{"name":49,"class":50},{"id":509,"slug":4,"hasResults":11,"nctId":510,"briefTitle":511,"officialTitle":512,"acronym":4,"eligibilityCriteria":513,"healthyVolunteers":57,"sex":16,"minAge":514,"maxAge":4,"enrollmentInfo":515,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":517,"conditions":518,"keywords":523,"overallStatus":74,"whyStopped":4,"lastUpdateSubmitDate":500,"lastUpdatePostDateStruct":529,"startDateStruct":530,"completionDateStruct":4,"leadSponsor":532,"locationsCount":51},"100078073","NCT00271622","The Neurodevelopmental and Behavioral Phenotyping Screening Protocol","Neurodevelopmental and Behavioral Phenotyping Screening Protocol","* INCLUSION CRITERIA:\n* Subjects must be at least 6 weeks of age.\n* Subjects or their parents must be competent to comprehend the purpose of the screening process and to provide written informed consent. Parents\u002Fguardians will sign the consent form, and both minors and adults (depending on results of capacity assessment) will be asked to assent only if it is determined that they understand their role in the study.\n* Subjects must be willing to undergo an evaluation which may include a psychiatric interview; and medical, neurological, and laboratory examinations (as appropriate, such as renal and liver function tests, serum electrolytes, urinalysis, blood levels of psychotropic drugs, and urine drug screen for the presence of psychoactive drugs and drugs of abuse, as determined on a subject-to-subject basis).\n\nEXCLUSION CRITERIA:\n\n-Lack of appropriate consent: For minor patients, consent must be obtained from all legal guardians\u002Fcaretakers, including both parents in separated or divorced families where there is shared legal custody of the child. In such cases, both parents must consent to the child s participation in this protocol.","6 Weeks",{"count":516,"type":21},5000,"The purpose of this protocol is to allow for the careful evaluation of healthy volunteers and individuals with risk for psychiatric disorders or neurodevelopmental disorders, such as autism spectrum disorder for specific protocols at NIH.",[519,520,521,522],"Neurologic Disorders","Autism","Neurodegenerative Disease","Neurobehavioral Manifestation",[524,35,525,526,527,528,72,73],"Developmental Delay","Pervasive Developmental Disorder","Early Development","Healthy Control Subjects","Autism Spectrum Disorders",{"date":502,"type":43},{"date":531,"type":43},"2006-02-27",{"name":49,"class":50},""]