[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Centre for Addiction and Mental Health\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":669},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,51,0,25,[9,48,83,111,139,170,195,224,253,284,309,336,365,387,411,437,457,481,496,516,545,566,594,618,640],{"id":10,"slug":4,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":24,"conditions":25,"keywords":29,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":37,"startDateStruct":40,"completionDateStruct":42,"leadSponsor":44,"locationsCount":47},"100053377",false,"NCT07699159","Cohort Network for Adolescents and Youth With multipLe Mental Health Conditions","Cohort Network for Adolescents and Youth With multipLe Mental Health Conditions (CALM): A Master Observational Trial","CALM","Inclusion Criteria:\n\nThe participant must meet all of the inclusion criteria to be eligible for this research study:\n\n* Light Phenotype Eligibility Must sign and date the informed consent form, or provide assent and have a Substitute Decision Maker provide informed consent; Aged 11-24 years old at the time of screening; Any person within age criteria who has previously sought, is seeking, or is accessing mental health services; Are able to complete assessments in English.\n\nDeep Phenotype Eligibility Must be part of the CALM light phenotype cohort; Must sign and date the deep phenotyping informed consent form, or provide assent and have a Substitute Decision Maker provide informed consent.\n\nLight Phenotype Caregiver Participant Eligibility:\n\nAny caregiver of a CALM child\u002Fyouth participant is eligible to participate in the study, insofar as the child\u002Fyouth participant has consented to the light phenotype cohort and has agreed for their caregiver to be contacted to participate in the study; Must sign and date the informed consent form.\n\nDeep Phenotype Caregiver Participant Eligibility:\n\nAny caregiver of a CALM child\u002Fyouth participant is eligible to participate in the study, insofar as the child\u002Fyouth participant has consented to the deep phenotype cohort and has agreed for their caregiver to be contacted to participate in the study; Must sign and date the informed consent form.\n\nExclusion Criteria:\n\nAn individual who meets any of the following criteria will be excluded from participation in this research study:\n\nLight Phenotype Does not provide informed consent (for those with the capacity to consent) or assent (for those who lack the capacity to consent); For those individuals who lack the capacity to consent, the inability of the parent\u002Flegal guardian to provide informed consent for the youth is also an exclusion criterion; Those who lack capacity to consent include individuals who are non-verbal or unable to speak any English.\n\nDeep Phenotype Unable to participate in deep phenotyping protocol (e.g., MRI contraindication, uncorrected vision or hearing impairments that would interfere with data collection, unwillingness to complete assessments); No exclusion criteria are based on race, ethnicity, sex or gender.\n\nLight Phenotype Caregiver Participant Ineligibility:\n\nCaregivers of CALM child\u002Fyouth participants are ineligible to participate in the study if:\n\nThe child\u002Fyouth participant does not agree for their caregiver to be contacted to participate in the study; The child\u002Fyouth participant is not participating in the light phenotype cohort; Does not provide informed consent (for those with the capacity to consent). Those who lack capacity to consent include individuals who are non-verbal or unable to speak any English.\n\nDeep Phenotype Caregiver Participant Ineligibility:\n\nCaregivers of CALM child\u002Fyouth participants are ineligible to participate in the study if:\n\nThe child\u002Fyouth participant does not agree for their caregiver to be contacted to participate in the study; The child\u002Fyouth participant is not participating in the deep phenotype cohort (i.e., is only participating in the light phenotyping cohort); Does not provide informed consent (for those with the capacity to consent). Those who lack capacity to consent include individuals who are non-verbal or unable to speak any English.","ALL","11 Years","24 Years",{"count":21,"type":22},1620,"ESTIMATED","OBSERVATIONAL","The Cohort Network for Adolescents and Youth With multipLe Mental Health Conditions (CALM) Master Observational Trial is a prospective, longitudinal observational study that seeks to improve clinical care for youth with multiple mental health conditions (MMHC), also known as mental health multimorbidity in the literature. MMHC is conceptualized as the presence of two or more mental health diagnoses under the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5). MMHC is common in youth seeking mental health services and is associated with less favorable outcomes and greater health services utilization. Mental health disorders also accumulate in youth over time. The Master Observational Trial (MOT) will investigate MMHC in critical developmental periods in youth and identify risk and protective factors that will provide a mechanistic understanding of how MMHC develops over time. A subset of participants will also enroll in a Deep Phenotyping Cohort, which includes enhanced clinical and cognitive assessments and multimodal neuroimaging to investigate neurobiological mechanisms underlying MMHC and identify potential biomarkers of illness complexity and progression.\n\nIn the near future, we aim to add to the current protocol to embed both a clinical trials network for youth mental health in Ontario and Calgary within the CALM study and add digital phenotyping using wearable technology to generate digital and physiological markers of MMHC. The current protocol focuses on establishing the longitudinal MOT cohort and Deep Phenotype Cohort only as a first step towards these long term CALM goals.",[26,27,28],"Multiple Mental Health Conditions","Child Mental Health","Youth Mental Health",[30,31,32,33,34],"multiple mental health conditions","child and youth mental health","mental health multimorbidity","master observational trial","deep phenotyping cohort","RECRUITING","2026-07-07",{"date":38,"type":39},"2026-07-13","ACTUAL",{"date":41,"type":39},"2025-03-04",{"date":43,"type":22},"2028-03-31",{"name":45,"class":46},"Centre for Addiction and Mental Health","OTHER",6,{"id":49,"slug":4,"hasResults":11,"nctId":50,"briefTitle":51,"officialTitle":52,"acronym":53,"eligibilityCriteria":54,"healthyVolunteers":55,"sex":17,"minAge":56,"maxAge":57,"enrollmentInfo":58,"targetDuration":4,"studyType":60,"phases":61,"briefSummary":63,"conditions":64,"keywords":67,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":74,"lastUpdatePostDateStruct":75,"startDateStruct":77,"completionDateStruct":79,"leadSponsor":81,"locationsCount":82},"100554348","NCT06497920","rTMS to Improve Motor Function in Autism","Modulating Plasticity in the Motor Cortex Using Repetitive Transcranial Magnetic Stimulation to Improve Motor Function in Autism Spectrum Disorder","(AMBLE Autism)","Inclusion Criteria:\n\nASD or control participants must meet all of the inclusion criteria to eligible for this study:\n\n1. Aged between 18 and 40 years old. 40 years is chosen as the cut-off because of the report of high rates of Parkinsonism in autistic adults \\> 39years;\n2. Have IQ\\>70;\n3. Are able to read, write and communicate effectively in English;\n4. Are able to provide informed consent. We will recruit only intellectually-able autistic adults. The intellectual ability will be determined using WASI-II. The ability to provide consent will be determined using clinical assessment.\n5. Have no prior history of seizure;\n6. Must sign and date the informed consent form;\n7. Stated willingness to comply with all study procedures;\n8. Agreement to adhere to Lifestyle Considerations, that is: refrain from consumption of alcohol, tobacco, marijuana, or caffeine on the day of study visits.\n\nAll ASD participants:\n\n1. Will have DSM-5 diagnosis of ASD without intellectual disability, confirmed by clinical assessment and the Autism Diagnostic Observation Schedule - 2 (ADOS-2);\n2. Will have significant motor function difficulties defined as a standard composite score \\\u003C40 (i.e., \\>1 standard deviation below the mean) on either fine or gross motor composite scores of the Bruininks-Oseretsky Test of Motor Proficiency, Second Edition or BOT-2;\n3. Are clinically stable as determined by clinical assessment, with no medication changes over the past 4 weeks. Given the high variability of handedness in ASD, we will include participants with left, right or mixed handedness.\n\nExclusion Criteria:\n\nASD or control participants will be excluded if they experience\u002Fhave:\n\n1. Current pregnancy;\n2. Current or past history of co-morbid medical condition that may require urgent medical intervention;\n3. DSM-5 substance use disorder (other than tobacco) within the past 6 months; however, all participants will be asked to refrain from smoking or taking caffeine four hours prior to the iTBS session;\n4. Significant hearing or visual impairment interfering with the ability to read or hear instructions;\n5. Significantly debilitating medical or neurologic illness (e.g., encephalitis, aneurysms, tumors, central nervous system infections), or acute or unstable medical illnesses as determined by project physician (e.g., uncontrolled diabetes);\n6. Metal implants or a pace-maker;\n7. Prior rTMS treatment;\n\nIn addition, ASD participants will be excluded if they report taking benzodiazepines or anticonvulsants currently.\n\nNT controls will be excluded if they have:\n\n1. Presence of psychopathology other than specific phobia, as screened by Personality Assessment Inventory and;\n2. A known diagnosis of Pervasive Developmental Disorder or ASD among any biologically related family members.",true,"18 Years","40 Years",{"count":59,"type":22},150,"INTERVENTIONAL",[62],"NA","In the current project, investigators have two main goals: i) Testing whether an excessive plasticity, i.e. hyperplasticity in the motor cortex underlies motor function difficulties in autistic adults, and ii) Using repetitive Transcranial Magnetic Stimulation (rTMS) with autistic adults to examine whether resulting reduced hyperplasticity in the motor cortex will be associated with clinical improvements in the motor function.",[65,66],"Autism Spectrum Disorder","Motor Activity",[68,69,70,71,72,73],"Autism","Motor Function","Repetitive Transcranial Magnetic Stimulation","Transcranial Magnetic Stimulation","Motor Cortex","Electroencephalography","2026-06-11",{"date":76,"type":39},"2026-06-15",{"date":78,"type":39},"2024-04-24",{"date":80,"type":22},"2029-06-30",{"name":45,"class":46},1,{"id":84,"slug":4,"hasResults":11,"nctId":85,"briefTitle":86,"officialTitle":87,"acronym":88,"eligibilityCriteria":89,"healthyVolunteers":55,"sex":17,"minAge":90,"maxAge":91,"enrollmentInfo":92,"targetDuration":4,"studyType":60,"phases":94,"briefSummary":95,"conditions":96,"keywords":98,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":104,"lastUpdatePostDateStruct":105,"startDateStruct":106,"completionDateStruct":108,"leadSponsor":110,"locationsCount":82},"100601050","NCT07105449","THC Titration of High-Potency Cannabis Concentrates","THC Titration of High-Potency Cannabis Concentrates: A Randomized Cross-Over Trial","THC Titration","Inclusion Criteria:\n\n* Age 19-55 years.\n* Frequency of primary exposure to cannabis 1-4 occasions per week, through any route of administration, over the past three months; participants must report experience with vaping high-potency liquid concentrates with more than 3 exposures to 90% THC and willingness to use such products in the study.\n* Refrain from cannabis for 48 hours and from alcohol for 12 hours before visits.\n* Agree not to drive a car for 24 hours after each visit.\n* Abstain from recreational drugs for at least 48 hours prior to each visit.\n* Abstain from any drugs not medically required.\n* Well-controlled blood pressure for participants with hypertension.\n\nExclusion Criteria:\n\n* Pregnant\u002Fbreastfeeding (women of childbearing potential must have a negative pregnancy test and report use of appropriate contraception).\n* Evidence of cardiac arrhythmias\u002Ffailure, ischaemic heart disease.\n* Recent open heart\u002Fopen chest surgery or cataract surgery.\n* Evidence from Structured Clinical Interview for DSM-5 \\[SCID-5-CT\\] or clinical evaluation of lifetime psychotic disorder\u002Fschizophrenia or bipolar disorder; family history of a first-degree relative with a diagnosis of psychotic disorder or schizophrenia; history of psychiatric co-morbidities in the past year (major depression, anxiety disorder or suicide attempt in past year or current suicidal ideation) and current substance use disorder\u002Fdependence.\n* Evidence of neurological illness (e.g., stroke, epilepsy, traumatic brain injury).\n* Renal or hepatic abnormalities (self-report and blood hematology\u002Fchemistry); and\n* Respiratory diseases, including asthma and physician-diagnosed lung disease.\n* Taking prescribed medications that contain either THC or cannabidiol (CBD).\n* Participation in another clinical or non-therapeutic study in the last three months.\n* Bleeding disorders.","19 Years","55 Years",{"count":93,"type":22},48,[62],"High-potency cannabis use is associated with public health risks, such as cannabis use disorder, psychotic disorders, and impaired cognition. Legal markets in the US and Canada are geared towards the commercialization of high-tetrahydrocannabinol (THC) products, including concentrates as high as 90-95%. The cannabis industry has resisted regulation of higher-potency products claiming that cannabis consumers naturally self-titrate their use, but the limited evidence to date suggests that even though consumers may use less cannabis as potency rises, consuming higher potency products still leads to greater THC consumption. The investigators will use a randomized crossover trial to evaluate the ability of 36 regular cannabis consumers (18 females and 18 males) to self-titrate the THC dose when vaping concentrates to achieve the desired psychoactive effects. The investigators will also characterize and compare the subjective, cognitive, physiological, and pharmacokinetic effects between cannabis concentrates of different potencies (30%, 60%, and 90% THC). Working with US scientists, the setting of this study will be Toronto, Canada, in the context of federal legalization of cannabis, unique access to cannabis products not available in the US for research purposes, and an encouraging regulatory environment. The investigators will test commercial products that are representative of the THC ranges available in the legal market. Aim 1: To evaluate the ability of regular cannabis consumers to self-titrate their THC dose when vaping concentrates of different potencies. The investigators will compare markers of titration (biological: THC blood levels; behavioral: inhalation topography; subjective: self-reported levels of intoxication) over a range of potencies for a comprehensive characterization of titration practice. The investigators hypothesize that participants will be able to partially but not proportionally reduce THC intake with increase in THC potency. In other words, the investigators anticipate that the proportional decrease in blood THC levels will be lower than the proportional increase in THC concentrations. Aim 2: To compare the cognitive impairment, physiological effects, and addiction liability of consuming lower versus higher THC potency concentrates. The investigators hypothesize that cognitive impairment and physiological effects will be less pronounced with lower-THC concentrates in a dose-response fashion. The investigators will also explore differences in addiction liability between potencies as higher THC concentrations may result in greater dysphoric reactions. These acute effects may be related to long term harms such as accidents, CVD events, and CUD. Exploratory Aim: To explore sex differences in titration efficiency, blood THC concentrations, cognitive impairment, physiological effects, and addiction liability. The investigators propose to analyze sex differences in our primary and secondary outcomes (e.g., whether females will be able to titrate more efficiently than males). This experimental evidence will provide data on the potential acute harms related to concentrates and inform policy decisions on the need to decrease access and\u002For prevent their initiation and implement information and education campaigns to increase awareness on the risks of using them.",[97],"THC",[99,100,101,102,103,97],"Cannabis","THC Concentrates","Self-Titration","Subjective Effects","Cognition","2026-06-09",{"date":74,"type":39},{"date":107,"type":39},"2025-10-01",{"date":109,"type":22},"2028-09-30",{"name":45,"class":46},{"id":112,"slug":4,"hasResults":11,"nctId":113,"briefTitle":114,"officialTitle":114,"acronym":115,"eligibilityCriteria":116,"healthyVolunteers":11,"sex":17,"minAge":56,"maxAge":117,"enrollmentInfo":118,"targetDuration":4,"studyType":60,"phases":120,"briefSummary":122,"conditions":123,"keywords":125,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":131,"lastUpdatePostDateStruct":132,"startDateStruct":134,"completionDateStruct":136,"leadSponsor":138,"locationsCount":82},"100555448","NCT06512220","Imaging the Effects of Serotonin 2A Receptor Modulation on Synaptic Density in Treatment-resistant Depression (SYNVEST)","SYNVEST","Inclusion Criteria:\n\n1. Adults 18 to 65 years old;\n2. Must be deemed to have capacity to provide informed consent;\n3. Must sign and date the informed consent form;\n4. Stated willingness to comply with all study procedures;\n5. Ability to read and communicate in English, such that their literacy and comprehension is sufficient for understanding the consent form and study questionnaires, as evaluated by study staff obtaining consent;\n6. Primary DSM-5 diagnosis of non-psychotic MDD, single or recurrent, based on the Structured Clinical Interview for DSM-5 (SCID-5) administered at the first screening visit;\n7. Participants diagnosed with treatment-resistant depression defined as individuals with a baseline HamD-17 score \\> 14 and that have not responded to two or more separate trials of antidepressants at an adequate dosage and duration (an antidepressant resistance rating score of three or more is considered an adequate trial) based on the Antidepressant Treatment History Form (ATHF); there is no upper limit on the number of treatment failures;\n8. Ability to take oral medication;\n9. Individuals who are capable of becoming pregnant: use of highly effective contraception for at least 3 months prior to screening and agreement to use such a method during study participation;\n10. Individuals who are willing to taper off current antidepressant and antipsychotic medications for a minimum of 2-weeks (or more depending on the medication) prior to Baseline (V2) and whose physician confirms that it is safe for them to do so; and\n11. Agreement to adhere to Lifestyle Considerations (section 4.5) throughout study duration.\n\nExclusion Criteria:\n\n1. Pregnant as assessed by a urine pregnancy test at Screening (V1) or individual's that intend to become pregnant during the study or are breastfeeding;\n2. Treatment with another investigational drug or other intervention within 30 days of Screening (V1);\n3. Have initiated psychotherapy in the preceding 12 weeks prior to Screening (V1);\n4. Have a DSM-5 diagnosis of substance use disorder (use of tobacco is permitted) within the preceding 6 months;\n5. Have active suicidal ideation with intent and plan as determined by item 3 of the HamD-17;\n6. Any DSM-5 lifetime diagnosis of a schizophrenia-spectrum disorder; obsessive-compulsive disorder, psychotic disorder (unless substance induced or due to a medical condition), bipolar I or II disorder, paranoid personality disorder, borderline personality disorder, or neurocognitive disorder as determined by medical history and the SCID-5 clinical interview;\n7. Any first-degree relative with a diagnosis of schizophrenia-spectrum disorder; psychotic disorder (unless substance-induced or due to a medical condition); or bipolar I disorder as determined by the family medical history form and discussions with the participant;\n8. Presence of a relative or absolute contraindication to psilocybin, including a drug allergy, recent stroke history, uncontrolled hypertension, low or labile blood pressure, recent myocardial infarction, cardiac arrhythmic, severe coronary artery disease, or moderate to severe renal or hepatic impairment.\n9. Presence of baseline prolonged QTc or Torsade de Pointes as measured by the ECG or a history of long QTc syndrome or related risk factors;\n10. History of allergy or contraindication to risperidone\n11. Current or past traumatic brain injury or other neurological\u002Fneurodegenerative disorder\n12. Unable or unwilling to undergo PET or MRI scanning (e.g. claustrophobia, pacemaker);\n13. Blood disorders, disorders of coagulation, or ongoing use of anticoagulant medication\n14. Any disability that may prevent the participant from completing study requirements (e.g., non-correctable clinically significant sensory impairment such as not hearing well enough to communicate with study personnel during scans, or physical disability that does not allow them to lie still on the scanner bed for 1-2 hours);\n15. Participant exceeds the annual or lifetime amount of radiation\n16. Any other clinically significant physical illness including chronic infectious diseases or any other major concurrent illness that, in the opinion of the investigator, may interfere with the interpretation of the study results or constitute a health risk for the participant if they take part in the study.","65 Years",{"count":119,"type":22},12,[121],"PHASE2","Limit: 5000 characters. Psilocybin, the chemical component of \"magic mushrooms\", has been administered with psychotherapy in several randomized clinical trials (RCTs) showing large and sustained antidepressant effects. In healthy volunteers, the psychedelic effects of psilocybin have been shown to be blocked by administration of certain medications such as risperidone.\n\nThe purpose of this study is to use an established SV2A radiotracer produced at our Centre to determine the feasibility of integrating PET imaging in to psilocybin trials. The preliminary imaging data will assess whether psilocybin's antidepressant effects are related to changes in synaptic density in adults with TRD, and whether any changes in synaptic density are associated with psilocybin's actions on the 5-HT2AR.",[124],"Treatment Resistant Depression",[126,127,128,129,124,130],"Psilocybin","Psychedelics","Clinical Trial","Positron-Emission Tomography","Neurophysiology Testing","2026-05-28",{"date":133,"type":39},"2026-06-01",{"date":135,"type":39},"2025-04-21",{"date":137,"type":22},"2027-09",{"name":45,"class":46},{"id":140,"slug":4,"hasResults":11,"nctId":141,"briefTitle":142,"officialTitle":142,"acronym":4,"eligibilityCriteria":143,"healthyVolunteers":55,"sex":17,"minAge":144,"maxAge":145,"enrollmentInfo":146,"targetDuration":4,"studyType":60,"phases":148,"briefSummary":149,"conditions":150,"keywords":153,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":163,"lastUpdatePostDateStruct":164,"startDateStruct":165,"completionDateStruct":167,"leadSponsor":169,"locationsCount":82},"100496803","NCT05748990","Does Abnormal Insulin Action in the Brain Underlie Cognitive and Metabolic Dysfunction in Schizophrenia","Inclusion Criteria:\n\ni) Experimental group (participants with a diagnosis of schizophrenia spectrum disorder):\n\n1. 17-45 years\n2. both sexes;\n3. Patients with first-episode schizophrenia spectrum illness: Primary DSM-5 diagnosis of schizophrenia, schizoaffective disorder, schizophreniform disorder, delusional disorder, brief psychotic disorder, psychotic disorder NOS, major depressive disorder with psychotic symptoms, bipolar I disorder, and bipolar II disorder, OR substance-induced psychosis, and antipsychotic treatment for schizophrenia, schizoaffective disorder, or other specified schizophrenia spectrum, other psychotic disorder, major depressive disorder with psychotic symptoms, bipolar I disorder, and bipolar II. (Diagnosis willbe confirmed via CAMH chart review).\n4. BMI under or equal to 27\n\nii) Control group (healthy controls):\n\n1. 17-45 years of age\n2. sex-,\n3. hand dominance -and\n4. body mass index (BMI)-matched\n5. Absence of DSM-5 diagnosis other than a specific phobia according to MINI\n\nExclusion Criteria:\n\n1. moderate or severe substance use according to MINI (per PI discretion in the case of moderate alcohol or cannabis use)\n2. prediabetes, diabetes, or evidence of impaired glucose tolerance on screening OGTT\n3. acute suicidal risk\n4. use of weight, lipid, antidiabetic or blood pressure reducing agents\n5. liver or kidney disease\n6. pregnancy\n7. nursing\n8. pacemakers\n9. metallic cardiac valves\n10. magnetic material such as surgical clips, implanted electronic infusion pumps or any other conditions that would preclude the MRI scan\n11. clinically significant claustrophobia (determined from MRI screening form; significance evaluated as per QI's discretion).\n12. history of head trauma resulting in loss of consciousness \\> 30 minutes that required medical attention;\n13. size of head, neck, precluding to fit in the MRI or PET scanners\n14. weight over 350lbs (limit for MRI scanner bed)\n15. unstable physical illness\n16. significant neurological disorder including a seizure disorder;\n17. Received maximum allowed radiation in the past 12 months (20 mSv)\n18. Completed more than 6 PET scans\u002F lifetime, that, together with the PET scanning procedures under this protocol will bring the total number of PET scans to more than the allowed\u002Flifetime (8 PET scans per lifetime). These limits are set by the Centre for Addiction and Mental Health Brain Health Imaging Centre Guideline.\n19. clinically relevant abnormality observed in medical history,\n20. current intake of any medication that may interfere with participation in the study or may confound the results of PET imaging (e.g. anti-diabetic medication).\n21. Disorders of coagulation, blood or ongoing use of anticoagulant medication\n\nControl group: Exclusionary criteria are as listed above for participants, in addition to:\n\n1\\) First degree family member with primary psychotic disorder.","17 Years","45 Years",{"count":147,"type":22},20,[62],"Cognitive impairment (such as challenges in thinking and memory) is a core aspect of schizophrenia (SCZ), contributing to disability and poor functional outcomes. Additionally, almost half of the patients with SCZ are obese, the prevalence of type 2 diabetes is 3-6 times higher, and life expectancy is lower by 15-20 years compared to the general population. This is relevant as metabolic syndrome and diabetes are both associated with worse cognition among SCZ patients. Recent work studying the relationships between metabolic health and cognition has encouraged a new way of thinking about SCZ as both a metabolic and cognitive disorder. Brain insulin is involved in several processes relevant to SCZ, and abnormal brain insulin action may help explain both cognitive and metabolic abnormalities in patients with SCZ, but this has not been examined previously. Glucose uptake in several brain regions relevant to SCZ has been shown to be partially dependent on insulin. Therefore, in this study, the researchers will measure glucose uptake in the brain using an 18F-fluorodeoxyglucose (\\[18F\\]-FDG) positron emission tomography (PET) scan after an intranasal insulin stimulus, and will compare this measure between patients with SCZ and healthy controls.",[151,152],"Schizophrenia","Healthy",[154,155,156,157,158,159,160,161,162],"schizophrenia","insulin","glucose","brain","PET","FDG","antipsychotic-naive","18-fluorodeoxyglucose","intranasal insulin","2026-05-26",{"date":131,"type":39},{"date":166,"type":39},"2023-04-01",{"date":168,"type":22},"2026-08-01",{"name":45,"class":46},{"id":171,"slug":4,"hasResults":11,"nctId":172,"briefTitle":173,"officialTitle":174,"acronym":4,"eligibilityCriteria":175,"healthyVolunteers":11,"sex":17,"minAge":56,"maxAge":4,"enrollmentInfo":176,"targetDuration":4,"studyType":60,"phases":178,"briefSummary":179,"conditions":180,"keywords":183,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":187,"lastUpdatePostDateStruct":188,"startDateStruct":190,"completionDateStruct":192,"leadSponsor":194,"locationsCount":82},"100604216","NCT07146633","Efficacy of an EMDR App for PTSD and SUD","Efficacy and Feasibility of Autonomous Eye Movement Desensitization and Reprocessing (A-EMDR) for Patients With Posttraumatic Stress Disorder (PTSD) and Substance Use Disorders","Inclusion Criteria:\n\n* Aged 18-years old or older\n* Fluent in English\n* Diagnosed with PTSD by the PTSD Checklist for DSM-5 (PCL-5 past month version score \\>32)\n* Diagnosed with past-year substance use disorder other than caffeine by structured clinical interview for DSM-5 (SCID-5)\n* Agrees not to participate in other treatments during the study duration (e.g., mindfulness, yoga, biofeedback, self-hypnosis or tai chi) except individuals who have been already on continuous therapies for at least three months\n\nExclusion Criteria:\n\n* Diagnosis of a severe or unstable mental illness that precludes safe participation in the study by a healthcare practitioner such as acute psychosis or mania diagnosed by a healthcare practitioner\n* Current suicidality risk as indicated during the conduct of the Columbia Suicide Severity Rating Scale (C-SSRS) (21) with concurrence after a study physician's evaluation if the response to C-SSRS questions 1 or 2 is \"yes\"",{"count":177,"type":22},24,[62],"The current proposal is aimed to confirm the efficacy of this novel therapeutic method (autonomous eye movement desensitization and reprocessing; A-EMDR) in a patient group (PTSD and SUD), and to assess the feasibility of the application within this group. While there is no basis to assume lower efficacy of the treatment with this population, confirming that hypothesis is an important and helpful step before a full-performance research study can be initiated. Furthermore, this study proposal will provide additional information regarding the feasibility for this population, which will allow for a more tailored approach in future study.",[181,182],"Posttraumatic Stress Disorder (PTSD)","Substance Use Disorders",[184,185,186],"EMDR","PTSD","substance dependence","2026-05-20",{"date":189,"type":39},"2026-05-22",{"date":191,"type":39},"2026-01-20",{"date":193,"type":22},"2027-01-30",{"name":45,"class":46},{"id":196,"slug":4,"hasResults":11,"nctId":197,"briefTitle":198,"officialTitle":198,"acronym":199,"eligibilityCriteria":200,"healthyVolunteers":11,"sex":17,"minAge":201,"maxAge":117,"enrollmentInfo":202,"targetDuration":4,"studyType":60,"phases":204,"briefSummary":205,"conditions":206,"keywords":209,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":216,"lastUpdatePostDateStruct":217,"startDateStruct":219,"completionDateStruct":221,"leadSponsor":223,"locationsCount":82},"100590906","NCT06973512","HABITS Study (Helping Addiction by Individualized Therapeutic Stimulation): Pilot Trial of Deep Brain Stimulation Guided By Stereoelectroencephalography for Treatment-Refractory Substance Use Disorders","HABITS","Inclusion Criteria:\n\n* Adult, Age 25-65\n* Severe DSM-5 substance use disorder (SUD) as assessed by Structured Clinical Interview for DSM-5 (SCID-5)\n* Treatment refractory as evidenced by non-response to an adequate trial of ≥2 evidence-based treatment modalities for their substance use disorder in the most recent 3 years of illness, as determined by the study clinical team\n* Able to comply with study visit schedule and timeline\n* Stable housing and reliable transportation\n* Treatment-seeking (\\>7 on a 0-10 readiness ruler and open to the end-of-treatment outcome of abstinence)\n* Capable of understanding and providing informed consent\n\nExclusion Criteria:\n\n* Contraindications to neurosurgical interventions such as major medical co-morbidities, including uncontrolled hypertension, coagulopathy, severe diabetes, major organ system failure, active infection or history of implant-related infections, immunocompromised state, or malignancy with \\\u003C5 years life expectancy\n* Contraindications for MRI, including implanted metallic devices (e.g., non-MRI-safe cardiac pacemaker or neurostimulator; some artificial joints metal pins; surgical clips; or other implanted metal parts), or claustrophobia or discomfort in confined spaces\n* Cardiac pacemaker\u002Fdefibrillator, or other implanted stimulator\n* Presence of epilepsy, stroke, or degenerative disorder of the nervous system\n* Serious problems with literacy, vision, or hearing","25 Years",{"count":203,"type":22},10,[62],"Substance use disorder (SUD) or addiction to drugs\u002Falcohol is a devastating disease. Over 40,000 overdose deaths have happened in Canada since 2016, 1 in 5 Canadians will have a SUD, and 70% of those with SUD continue to relapse, showing that we urgently need new treatments. The Helping Addiction by Individualized Therapeutic Stimulation (HABITS) Study is exploring deep brain stimulation (DBS) for people who have failed to quit harmful substances.\n\nOver 250,000 people have received DBS, which is well-established for Parkinson's disease and has evidence of success in major depression and obsessive-compulsive disorder. DBS uses electricity to directly stimulate areas of the brain. However, for DBS to work effectively, it needs to be personalized to each individual, which will be pursued through stereoelectroencephalography (SEEG). DBS and SEEG are minimally invasive and reversible, with a low risk of side effects.\n\nSEEG started over 70 years ago to find seizure location in the brain of children and adults with epilepsy. It now has been used for major depression and chronic pain to guide DBS. It involves inserting electrodes temporarily across critical brain areas and monitoring patients for several days. SEEG can provide an understanding of where addiction and craving are in the brain to guide the placement of DBS electrodes and device settings that are optimal for a person.\n\nIn the HABITS Study, 10 participants will receive DBS guided by SEEG and undergo 11 study visits. Individuals will first undergo detoxification with CAMH. Then, they will receive DBS and SEEG at Toronto Western Hospital, where they will stay for 1 to 2 weeks. Finally, they will be followed for a year, where they will receive standard psychiatric care.\n\nSUD causes heavy burdens on individuals, families, healthcare systems, and society. The HABITS Study promises to personalize DBS to treat those who are struggling with severe addiction.",[207,208],"Addiction","Substance Use Disorder (SUD)",[210,211,212,213,214,215],"addiction","substance use disorder","deep brain stimulation","stereoelectroencephalography","biomarker","electrophysiology","2026-04-27",{"date":218,"type":39},"2026-04-29",{"date":220,"type":39},"2024-11-01",{"date":222,"type":22},"2028-01-01",{"name":45,"class":46},{"id":225,"slug":4,"hasResults":11,"nctId":226,"briefTitle":227,"officialTitle":228,"acronym":4,"eligibilityCriteria":229,"healthyVolunteers":11,"sex":17,"minAge":56,"maxAge":4,"enrollmentInfo":230,"targetDuration":4,"studyType":60,"phases":232,"briefSummary":234,"conditions":235,"keywords":240,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":246,"lastUpdatePostDateStruct":247,"startDateStruct":249,"completionDateStruct":251,"leadSponsor":252,"locationsCount":82},"100399257","NCT04478838","\"Extended\" (Alternate Day) Antipsychotic Dosing","\"Re-examining Maintenance Antipsychotic Treatment in Schizophrenia: \"Extended\" Antipsychotic Dosing\"","Inclusion Criteria:\n\n(i) A primary diagnosis of a Schizophrenia Spectrum or Other Psychotic Disorder as defined by the DSM-5 diagnosis and confirmed by the MINI (Version 7.0.2)\n\n(ii) age 18 or older\n\n(iii) female participants of childbearing potential must be using a reliable method of contraception and have a negative pregnancy test at the time of enrolment and must, in the investigator's opinion, practice a clinically accepted, reliable method of contraception during this study. Male participants must not father a baby during their time in the study\n\n(iv) ability to communicate in English\n\n(v) capacity to provide written, informed consent, as assessed using the MacCAT-CR at time of consent\n\n(vi) stabilized as outpatients with a single oral AP (risperidone or olanzapine or paliperidone\\*) at the same dose for ≥3 months i. On a prescribed risperidone dose of between 1-6mg, or a prescribed olanzapine dose of between 5-20mg, or a prescribed paliperidone 3-12mg\n\n(vii) evidence of adherence with current AP treatment\n\nExclusion Criteria:\n\n(i) exposure to a depot AP within 1 year (i.e., no depot AP injection within the last year)\n\n(ii) Current diagnosis of substance use disorder according to DSM-5 criteria (verified through the MINI for Psychotic Disorders (Version 7.0.2) and a positive drug screen for street and \u002For prescription drugs not prescribed to the participant by treating physicians\n\n(iii) ECT within the last 3 months\n\n(iv) pregnancy or lactation\n\n(v) neurological condition (dementia including Alzheimer's disease, multiple sclerosis, epilepsy, stroke, or traumatic brain injury)\n\n(vi) allergy to the study drugs and their excipients\n\n(vii) allergy (e.g., galactosaemia) or severe intolerance to lactose\n\n(viii) negative urine drug screen result for Olanzapine or Risperidone or Paliperidone (if applicable)",{"count":231,"type":22},120,[233],"PHASE4","The study wishes to examine whether \"extended\" antipsychotic treatment, in this case, antipsychotic treatment every other day, is as effective as daily treatment. It is also evaluating whether there may be differences in terms of side effects.\n\nParticipants will be randomly assigned to either the treatment as usual group (i.e., taking antipsychotic daily) or the extended dosing group (i.e., taking antipsychotic one day on, one day off). That means, like flipping a coin, there is a 50\u002F50 chance that participants will continue on daily dosing of your antipsychotic or have it switched to every other day dosing.\n\nThis study will last for 1 year. Participants will be evaluated at the beginning and every two weeks during the first 6 months, with visits once every 4 weeks for the final 6 months. In total, participants will make 22 visits over 52 weeks to the investigator's office.\n\nThe investigators hypothesize that with ED, there will be no change in symptom severity but improvement in the frequency and severity of side effects, wellbeing, and functioning.",[236,237,238,239],"Schizophrenia and Related Disorders","Drug Administration Schedule","Drug Therapy","Antipsychotic Agents",[241,242,243,244,245],"Extended Dosing","Alternate day dosing","Olanzapine","Risperidone","Paliperidone","2026-04-08",{"date":248,"type":39},"2026-04-13",{"date":250,"type":39},"2022-06-06",{"date":109,"type":22},{"name":45,"class":46},{"id":254,"slug":4,"hasResults":11,"nctId":255,"briefTitle":256,"officialTitle":257,"acronym":258,"eligibilityCriteria":259,"healthyVolunteers":11,"sex":17,"minAge":260,"maxAge":4,"enrollmentInfo":261,"targetDuration":4,"studyType":60,"phases":262,"briefSummary":263,"conditions":264,"keywords":266,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":277,"lastUpdatePostDateStruct":278,"startDateStruct":279,"completionDateStruct":281,"leadSponsor":283,"locationsCount":82},"100576283","NCT06783283","TACS to Engage Theta-Gamma Coupling and Enhance Working Memory in Patients With MCI (tACS-MCI)","Transcranial Alternating Current Stimulation to Engage Theta-Gamma Coupling and Enhance Working Memory in Patients With Mild Cognitive Impairment","tACS-MCI","Inclusion Criteria:\n\n1. Age 60 years or above,\n2. Diagnosis of MCI due to AD using the core clinical criteria by the National Institute on Aging and Alzheimer's Association for MCI participants (NIA-AA) and ascertained by a study investigator. The following checklist will be used to ascertain the MCI diagnosis:\n\n   1. Cognitive concern reflecting a change in cognition reported by patient or informant or clinician (i.e., historical or observed evidence of decline over time)\n   2. Not demented ascertained using the study investigator opinion.\n   3. No vascular, traumatic, or medical causes of cognitive decline ascertained using the study investigator opinion.\n   4. Evidence of longitudinal decline in cognition, when feasible, and ascertained using the study investigator opinion.\n3. Objective evidence of single or multi domain MCI, where single domain MCI refers to deficits using neuropsychology (NP) battery on only one of the cognitive domains (Speed of Processing; Working Memory; Executive Functioning; Verbal Memory; Visual Memory; Language) and multi domain MCI refers to deficits in more than one of these domains. To determine impairment in one or more cognitive domain, after the NP battery is administered and double scored, a consensus meeting will be held with the Research Analyst\u002FFellow, the study Principal Investigator and the study Neuropsychologist during which eligibility will be discussed. The meeting attendees will take into consideration the participant's education, parental education, pre-morbid IQ, physician's assessment and NP scores to determine if the participant has impairment in one or more cognitive domain.\n4. Willingness to provide informed consent,\n5. Ability to read and communicate in English (with corrected vision and hearing, if needed)\n\nExclusion Criteria:\n\n1. Current use of an acetylcholine esterase inhibitor or memantine ascertained via participant's report, Medication List, or Electronic Medical Record (EMR).\n2. Major Depressive Disorder with active symptoms in the last 3 months ascertained using the Mini International Neuropsychiatric Interview (MINI), or Structured Clinical Interview for DSM-5 (SCID), or EMR.\n3. A lifetime diagnosis of bipolar disorder; intellectual disability; or a psychotic disorder ascertained using the MINI or SCID, or EMR.\n4. Substance use disorder active in the last 3 months ascertained using the MINI or SCID, or EMR.\n5. Any other DSM-5 diagnosis ascertained using the MINI or SCID, or EMR, that may be associated with prefrontal cortical dysfunction as ascertained using a study investigator opinion.\n6. Current anticonvulsant use due to its impact on brain stimulation induced activity and ascertained using a Medication List or EMR. An exception will be made if they are taking gabapentin or pregabalin AND if the dose had been stable for at least 4 weeks prior to study entry AND if prescribed for chronic pain.\n7. Current benzodiazepine use of more than what is equivalent to lorazepam 2 mg\u002Fday as ascertained using a Medication List. This is due to their known pro-GABAergic activity and the suppressive effect of GABAergic agents on cortical plasticity\n8. Any contraindication to MRI or contraindication to tACS (e.g., cardiac pacemaker, acoustic device, history of seizures) ascertained using the tACS Safety Screen (tSS)","60 Years",{"count":147,"type":22},[62],"This study is looking at a new non-invasive brain stimulation methods called transcranial alternating current stimulation (tACS) to see if it can improve working memory and thinking processes in people with Mild Cognitive Impairment (MCI). tACS is a low-risk, non-painful, low electrical current that circulates through the brain of awake participants and stimulates their brain cells. Participants must be 60 years of age and have a diagnosis of mild cognitive impairment. Participants will undergo treatment sessions that range from 1 to 1.5 hours at CAMH, 5 days a week, over a total of 2 weeks. In addition, participants will complete clinical and cognitive assessments and bloodwork at baseline and again after treatment.",[265],"Mild Cognitive Impairment (MCI)",[267,268,269,270,73,271,103,272,273,274,275,276],"Memory Impairment","Executive Function","Transcranial Alternating Stimulation","Neuroplasticity","Working Memory","Prefrontal Cortex","Transcranial Electrical Stimulation","Dementia","Alzheimer's Disease","Temporal Cortex","2026-04-07",{"date":248,"type":39},{"date":280,"type":39},"2025-01-02",{"date":282,"type":22},"2027-12",{"name":45,"class":46},{"id":285,"slug":4,"hasResults":11,"nctId":286,"briefTitle":287,"officialTitle":287,"acronym":4,"eligibilityCriteria":288,"healthyVolunteers":55,"sex":17,"minAge":56,"maxAge":289,"enrollmentInfo":290,"targetDuration":4,"studyType":60,"phases":292,"briefSummary":293,"conditions":294,"keywords":297,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":301,"lastUpdatePostDateStruct":302,"startDateStruct":304,"completionDateStruct":306,"leadSponsor":308,"locationsCount":82},"100601342","NCT07109245","Do Antipsychotics Block Insulin Action in the Brain: is it a Class Effect?","Inclusion Criteria:\n\n1. Must be deemed to have the capacity to provide informed consent\n2. Must sign and date the informed consent form\n3. Stated willingness to comply with all study procedures;\n4. Age: 18-35\n5. Body Mass Index (BMI) 18.5-24.9 kg\u002Fm2\n6. Both sexes\n\nExclusion Criteria:\n\n1. History of psychiatric illness, including any substance use (screened using the Mini International Neuropsychiatric Interview (MINI))\n2. Pre-diabetes or diabetes (fasting glucose ≥6.0 mmol\u002FL, HbA1c\\>6% or use of anti-diabetic drug),\n3. Evidence of impaired insulin sensitivity, assessed using the Homeostatic Model Assessment for Insulin Resistance (HOMA-IR) ≥2.5\n4. Family history of diabetes in a first degree relative (parent or sibling)\n5. Use of weight reducing agents\n6. History of kidney or liver disease\n7. History of cell blood disorders\n8. Irregular menstrual cycles (e.g., menstruation occurs less than 21 days or more than 35 days apart, or not having menstruated for three months (or 90 days), or conditions such as endometriosis or polycystic ovary syndrome (PCOS) or prior surgical interventions such as a hysterectomy or oophorectomy)\n9. Current use of hormonal birth control (e.g., pill, patch, hormonal intrauterine device \\[IUD\\], ring). Participants must have had at least 2 regular menstrual cycles following the discontinuation of hormonal birth control \\[50\\]\n10. Current use of progesterone, estrogen, testosterone, or fertility treatment.\n11. Pregnant, gave birth in the last year, or breastfeeding. Participants must have at least 3 regular menstrual cycles post-breastfeeding before beginning the study.\n12. Major medical or surgical event within the last 6 months\n13. Contraindications for MRI, including metal implants, pacemakers, cochlear implants, claustrophobia, weight \\>250 lbs\n14. Any contraindications to the investigational products as listed in the product monographs including known hypersensitivity to the drug or the excipients of the product (note: enzymatic lactose intolerance is NOT exclusionary),\n15. Any medications that increases risk of hypoglycemia or could contribute to hyperglycemia\n16. Any medical conditions that constitute as a warning\u002Fprecaution for haloperidol, lorazepam, benztropine, or insulin.\n17. Use of any of the prohibited medications listed in the product monograph of haloperidol, lorazepam, benztropine, or insulin (Pheochromocytoma, barbiturates, and narcotics are exclusionary, any use of painkillers and antihistamines must be reviewed by PI but are not exclusionary","35 Years",{"count":291,"type":22},35,[233],"This study aimed at helping researchers understand how a medication called haloperidol can affect insulin action in the brain. Insulin is a hormone in the body that controls sugar levels in part by lowering the amount of glucose produced by the liver. After eating a meal, insulin levels go up in both the blood and the brain. Insulin in the brain has also been shown to affect the way the brain works and processes information (also known as \"cognition\"). Haloperidol, is an antipsychotic medication used to treat a variety of disorders such as schizophrenia spectrum disorders, bipolar disorder, and major depressive disorder, but long-term use can have metabolic side effects, like weight gain, type 2 diabetes, and cardiovascular disease. The purpose of this study is to investigate how antipsychotic medications, such as haloperidol, which carries the risk of metabolic changes, might interrupt the effect of insulin action in the brain. This will help researchers learn how to potentially reduce metabolic risk for people who take these kinds of medications in the future.",[295,296,103],"Brain Insulin Sensitivity","Healthy Controls",[295,298,299,103,300],"Healthy Control Study","Haloperidol","MRI","2026-03-30",{"date":303,"type":39},"2026-04-02",{"date":305,"type":39},"2025-12-11",{"date":307,"type":22},"2028-12",{"name":45,"class":46},{"id":310,"slug":4,"hasResults":11,"nctId":311,"briefTitle":312,"officialTitle":313,"acronym":4,"eligibilityCriteria":314,"healthyVolunteers":55,"sex":17,"minAge":56,"maxAge":315,"enrollmentInfo":316,"targetDuration":4,"studyType":60,"phases":318,"briefSummary":319,"conditions":320,"keywords":322,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":328,"lastUpdatePostDateStruct":329,"startDateStruct":331,"completionDateStruct":333,"leadSponsor":335,"locationsCount":82},"100542681","NCT06346028","Implementation of Transcranial Magnetic Stimulation for Smoking Cessation","A Pragmatic Feasibility Trial on the Implementation of Transcranial Magnetic Stimulation for Smoking Cessation","Inclusion Criteria: Patients receiving rTMS\n\n* Smoking cigarettes daily (self-reported)\n\nInclusion Criteria: Health care providers\n\n* Currently employed as a HCP (physician, social worker, occupational therapist, etc.) at the CAMH NDC\n* Involved in the care of at least 1 patient who has received rTMS for smoking cessation\n\nExclusion Criteria: Patients receiving rTMS\n\n* Have any intracranial implant (e.g., aneurysm clips) or any other metal object within or near the head, excluding the mouth, that cannot be safely removed.\n* Pregnant or intending to be pregnant during the study.\n* A history of a primary seizure disorder, seizure associated with an intracranial lesion, recurrent seizures related to substance intoxication or withdrawal or recent seizure within the last 6 months.\n* Taking any anticonvulsant medication unless it cannot be tapered or discontinued due to risk of clinical safety or destabilization, according to the participant or their referring physician.\n* Taking benzodiazepines with dose equivalent or greater than lorazepam 2mg\u002Fday unless it cannot be tapered or discontinued due to risk of clinical safety or destabilization, according to the participant or their referring physician.\n* Space occupying intracranial lesion.\n* Acutely unstable medical, psychiatric, or substance use disorder comorbidity with safety concerns at the discretion of the PI or study physician.\n\nExclusion Criteria: Health care providers\n\n\\- There are no exclusion criteria for HCP Participants","70 Years",{"count":317,"type":22},40,[233],"Repetitive transcranial magnetic stimulation (rTMS) is an alternative non-invasive treatment to help people quit smoking. rTMS uses a magnetic field to stimulate regions of the brain that are involved in addiction. The two brain regions that are stimulated are the insula and the dorsolateral prefrontal cortex, which are involved in drug craving and decision-making, respectively.\n\nThe goal of this clinical trial is to learn more about the feasibility of offering rTMS as a treatment in the Nicotine Dependence Clinic (NDC) to help daily smokers to quit smoking. The NDC is at the Center for Addiction and Mental Health (CAMH) at 1025 Queen Street West, in Toronto, Canada.\n\nParticipants will be asked to come to CAMH to:\n\n* Complete surveys and optional interviews to learn more about their opinions and experiences with this treatment\n* Start a treatment course that includes 3 weeks of daily (Monday to Friday) rTMS sessions followed by 3 weeks of weekly rTMS sessions for a total of 6 weeks. Each session lasts about 25 minutes and is provided by an rTMS technician with medical supervision.\n\nObjectives\n\n• Learning about the feasibility of rTMS as a treatment option for patients in the NDC will help us improve the treatment when offering it in other clinics, which may help improve smoking quit rates and people's overall health.",[321],"Smoking",[323,324,325,326,327],"smoking cessation","quitting smoking","repetitive transcranial magnetic stimulation","rTMS","nicotine dependence","2026-03-26",{"date":330,"type":39},"2026-03-27",{"date":332,"type":39},"2024-03-30",{"date":334,"type":22},"2028-06-30",{"name":45,"class":46},{"id":337,"slug":4,"hasResults":11,"nctId":338,"briefTitle":339,"officialTitle":340,"acronym":4,"eligibilityCriteria":341,"healthyVolunteers":55,"sex":342,"minAge":56,"maxAge":289,"enrollmentInfo":343,"targetDuration":4,"studyType":60,"phases":345,"briefSummary":346,"conditions":347,"keywords":352,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":328,"lastUpdatePostDateStruct":359,"startDateStruct":361,"completionDateStruct":363,"leadSponsor":364,"locationsCount":82},"100535423","NCT06251635","Effects of Antipsychotics on Brain Insulin Action in Females","Effects of Antipsychotics on Brain Insulin Action in Females: A Randomised Placebo-Controlled, Crossover Multi-Modal Neuroimaging Study","Inclusion Criteria:\n\n* Age: 18-35 years\n* Body Mass Index (BMI) between 18.5 - 24.9 kg\u002Fm2\n* Normal menstrual cycle (defined as cycle length ranging from 21 to 35 days over the past 6 months).\n\nExclusion Criteria:\n\n* History of psychiatric illness (screened using the Mini International Neuropsychiatric Interview (MINI));\n* Pre-diabetes or diabetes (fasting glucose ≥6.0 mmol\u002FL, HbA1c\\>6% or use of anti-diabetic drug);\n* Evidence of impaired insulin sensitivity, assessed using the Homeostatic Model Assessment for Insulin Resistance (HOMA-IR) ≥2.5;\n* Family history of diabetes in a first degree relative (parent or sibling)\n* Use of weight reducing agents;\n* History of kidney or liver disease;\n* Moderate-to-severe substance use;\n* Irregular menstrual cycles (e.g., menstruation occurs less than 21 days or more than 35 days apart, or not having menstruated for three months (or 90 days), or conditions such as endometriosis or polycystic ovary syndrome (PCOS) or prior surgical interventions such as a hysterectomy or oophorectomy);\n* Current use of hormonal birth control (e.g., pill, patch, hormonal intrauterine device \\[IUD\\], ring). Participants must have had at least 2 regular menstrual cycles following the discontinuation of hormonal birth control;\n* Pregnant, gave birth in the last year, or breastfeeding. Participants must have at least 3 regular menstrual cycles post-breastfeeding before beginning the study;\n* Current use of progesterone, estrogen, testosterone, or fertility treatment;\n* Major medical or surgical event within the last 6 months;\n* Any condition that interferes with safe acquisition of MRI data such as metal implants, pacemakers, cochlear implants, claustrophobia, etc.\n* Any contraindications to the investigational products as listed in the product monographs including known hypersensitivity to the drug or the excipients of the product (note: enzymatic lactose intolerance is NOT exclusionary)\n* Use of any of the prohibited medications listed in the product monograph of olanzapine (e.g., Levodopa and dopamine agonists and antihypertensive agents).","FEMALE",{"count":344,"type":22},15,[62],"Females treated with antipsychotics have higher rates of comorbid metabolic syndrome than males. Despite this, females have historically been excluded from many mechanistic studies due to confounding effects of menstrual cycles. Recent evidence suggests that brain insulin resistance may be an underlying mechanism through which antipsychotics may exert their metabolic side effects. This study seeks to investigate how brain insulin action differs in females according to their menstrual cycle phase, and how a high metabolic liability agent such as olanzapine might interrupt these differential insulin effects. Young healthy females will be given olanzapine and intranasal insulin to test how these treatment combinations change brain processes. Participants will be tested during both the first half of their menstrual cycle (follicular phase) and the second half of their cycle (luteal phase). The investigators predict that intranasal insulin will change MRI-based measures in females, in a comparable way to males, in the follicular phase only. Adding olanzapine will block these effects of insulin in females in the follicular phase. This investigation has the potential to generate new knowledge in an area of significant unmet need. Demonstrating that antipsychotics disrupt brain insulin action, evidenced by inhibition of recognized effects of insulin on neuroimaging measures, will provide novel insights into currently poorly understood mechanisms.",[348,349,350,351],"Insulin Resistance","Menstrual Cycle","Type 2 Diabetes","Antipsychotics",[351,353,354,355,349,356,357,243,358],"Brain Insulin Resistance","Magnetic Resonance Imaging (MRI)","Metabolic Disturbances","Hyperinsulinemia","Insulin Lispro","Physiological Effects of Drugs",{"date":360,"type":39},"2026-03-31",{"date":362,"type":39},"2024-06-03",{"date":168,"type":22},{"name":45,"class":46},{"id":366,"slug":4,"hasResults":11,"nctId":367,"briefTitle":368,"officialTitle":369,"acronym":4,"eligibilityCriteria":370,"healthyVolunteers":11,"sex":17,"minAge":56,"maxAge":117,"enrollmentInfo":371,"targetDuration":4,"studyType":60,"phases":373,"briefSummary":374,"conditions":375,"keywords":377,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":328,"lastUpdatePostDateStruct":381,"startDateStruct":382,"completionDateStruct":384,"leadSponsor":386,"locationsCount":82},"100505283","NCT05859347","Repetitive Transcranial Magnetic Stimulation for Cannabis Use Disorder","Development of a Novel, Scalable, Neurobiologically-Guided Transcranial Magnetic Stimulation Protocol for the Treatment of Cannabis Use Disorder","Inclusion Criteria:\n\n1. Must be deemed to have capacity to provide informed consent\n2. Age between 18 to 65\n3. Diagnosis of cannabis use disorder according to the DSM-5 and the Structured Clinical Interview for DSM-5 (SCID for DSM-541)\n4. Report cannabis as the primary drug of concern, a frequent pattern of use (≥5 days per week), and a goal of reduction or abstinence of cannabis use\n5. CUDIT-R score ≥12\n6. Marijuana Contemplation Ladder ≥7\n7. Cannabis positive urine drug screen, with Narcochek baseline THC-COOH level of \\>150 ng\u002Fml.\n8. On a stable regimen of their psychotropic medications for 14 days before enrolment.\n\nExclusion Criteria:\n\n1. Pregnant or intending to be pregnant during the study\n2. Diagnosis of bipolar disorder, schizophrenia spectrum disorder, or other active concurrent psychiatric disorder that is too unstable and may preclude safe participation in the trial as deemed by the PI.\n3. Substance use disorder other than cannabis or nicotine, that is of moderate severity or greater, or is the primary substance of concern based on the SCID for DSM-5\n4. Known active seizure disorder, significant head injury with an imaging verified lesion\n5. Unstable medical illness\n6. Presence of cardiac pacemaker, intracranial implant, or metal in the cranium\n7. Participants taking \\> 2 mg lorazepam (or a benzodiazepine at an equivalent dose) or taking any anticonvulsant medication during treatment.",{"count":372,"type":22},46,[62],"There has been a considerable rise in cannabis consumption in recent years, with estimates of 200 million individual users globally. Importantly, 3% of these individuals have cannabis use disorder (CUD), with this prevalence increasing to 33% amongst regular users, making it one of the most common substances use disorders (SUDs) worldwide. CUD is associated with substantial health, societal, and economic costs, and worsening of other psychiatric disorders. Despite this clinical burden, effective treatment options are limited. No pharmacological treatments have emerged as clearly efficacious, and psychotherapeutic interventions have shown tempered results.\n\nRepetitive transcranial magnetic stimulation (rTMS) is a non-invasive brain-based approach in which alternating magnetic fields are applied to the scalp to induce electrical currents in cortical tissue. As it can modulate neural circuits implicated in neuropsychiatric disorders, it is a promising brain-based approach in the treatment of addictions. Evidence has indicated its efficacy in reducing drug craving and consumption across numerous SUDs, although research into cannabis has been largely unexplored. Recently, a novel circular rTMS coil, the MagVenture MMC-140, has been developed with the capacity to modulate both the bilateral prefrontal cortex (PFC) and insula, both of which are implicated in the neurocircuitry of craving and executive function. As such, it shows potential for CUD treatment.\n\nThis proof-of-concept clinical trial will evaluate the feasibility and tolerability of a 4-week course of rTMS to the PFC\u002Finsula using MMC-140 as a treatment for CUD. Feasibility of both high frequency (HF; excitatory) and low frequency (LF; inhibitory) stimulation parameters will be evaluated. In addition, pre\u002Fpost rTMS changes in cannabis use outcomes (e.g., consumption, craving, and withdrawal), executive function, and PFC\u002Finsula functional connectivity will be explored. By comprehensively investigating clinical, cognitive, and neuroimaging effects of rTMS, this study could pave the way for the first brain-based intervention in CUD that could be widely adopted into clinical settings using a novel, cost-effective and accessible rTMS device.",[376],"Cannabis Use Disorder",[70,99,378,272,379,380],"Substance Use Disorder","Insula","Neuroimaging",{"date":330,"type":39},{"date":383,"type":39},"2023-05-15",{"date":385,"type":22},"2027-06-15",{"name":45,"class":46},{"id":388,"slug":4,"hasResults":11,"nctId":389,"briefTitle":390,"officialTitle":391,"acronym":392,"eligibilityCriteria":393,"healthyVolunteers":11,"sex":17,"minAge":394,"maxAge":117,"enrollmentInfo":395,"targetDuration":4,"studyType":60,"phases":397,"briefSummary":398,"conditions":399,"keywords":403,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":328,"lastUpdatePostDateStruct":405,"startDateStruct":406,"completionDateStruct":408,"leadSponsor":410,"locationsCount":82},"100496457","NCT05744479","Metformin for Antipsychotic-induced Weight Gain in Adults With Intellectual Disability","Metformin for Antipsychotic-induced Weight Gain in Adults With Intellectual Disability: A Double-Blind Randomized Control Trial","METIDD","Inclusion Criteria:\n\n* Stable outpatients\n* Age 16-65 years\n* Diagnosed with an IDD\n* On maintenance treatment with an antipsychotic (stable dose for ≥3 months).\n* BMI must be ≥30 kg\u002Fm2, OR ≥27 kg\u002Fm2 with at least one weight-related comorbidity (treated or untreated) such as: hypertension, dyslipidaemia, obstructive sleep apnea, or impaired fasting glucose, OR \\>=25 for individuals who have gained \\> 5% body weight in association with AP use.\n* Females of child-bearing age must be on one of the following regular contraceptives:\n\n  1. Agree to abstain from sex for the duration of the trial or\n  2. A barrier method of a diaphragm with spermicide and\u002For Latex condom or\n  3. An oral contraceptive agent, implantable contraceptive or an injectable contraceptive for at least six months prior to entering the study and will continue its use throughout the study, or\n  4. An intrauterine device, or\n  5. Partner has had a vasectomy at least 3 months prior to study start\n\nExclusion Criteria:\n\n* Females who are nursing, currently pregnant, or have a positive pregnancy test\n* Clinical or laboratory evidence of uncompensated cardiovascular, endocrine, haematological, hepatic, renal, or pulmonary disease\n* Previous treatment and lack of efficacy or tolerability with metformin\n* History or diagnosis of Type 1 Diabetes (T1D) or Type 2 Diabetes (TD2) or fasting blood work, HbA1c \\> 6.5%\n* History of metabolic acidosis or lactic acidosis\n* Treatment with weight-lowering agents\n* Medications with significant renal impact\n* Major medical or surgical event in the preceding 3 months\n* Acute suicidal risk.\n* Moderate to severe substance use disorder, other than caffein or nicotine use disorder","16 Years",{"count":396,"type":22},100,[233],"People with IDD (intellectual and developmental disability) have very high rates of obesity and die prematurely from cardiometabolic disease. While antipsychotics contribute to this problem, their use is necessary and appropriate in a significant subgroup of individuals with IDD. Exercise and diet interventions have limitations and may not be sufficient, requiring effective adjunctive pharmacological approaches to target obesity and related comorbidities in IDD. However, persons with IDD treated with antipsychotics are systematically excluded from clinical trials hindering development of evidence to help guide safe and effective treatment of these comorbidities. Moreover, evidence from other disorders cannot be extrapolated to IDD given inherent biological differences between disorders. This trial will address the identified gaps, which extend beyond cardiovascular morbidity and negatively impact psychosocial outcomes, in a hugely underserviced population.This is the the first RCT (randomized control trial) to examine the efficacy of metformin in overweight or obese adults with IDD who have experienced antipsychotic-induced weight gain. By generating efficacy data for a very accessible and scalable intervention, allows for guideline and implementation strategies to address a recalcitrant health problem.",[400,401,402],"Intellectual Disability","Developmental Disability","Obesity",[400,401,402,404],"Metformin",{"date":360,"type":39},{"date":407,"type":39},"2023-02-28",{"date":409,"type":22},"2027-03-01",{"name":45,"class":46},{"id":412,"slug":4,"hasResults":11,"nctId":413,"briefTitle":414,"officialTitle":415,"acronym":4,"eligibilityCriteria":416,"healthyVolunteers":11,"sex":17,"minAge":394,"maxAge":289,"enrollmentInfo":417,"targetDuration":4,"studyType":60,"phases":419,"briefSummary":420,"conditions":421,"keywords":423,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":430,"lastUpdatePostDateStruct":431,"startDateStruct":432,"completionDateStruct":434,"leadSponsor":436,"locationsCount":82},"100450226","NCT05142735","Effects of NAC on Symptoms of CHR Patients","Effects of N-acetylcysteine on Psychosis-like Symptoms and a Neurophysiological Biomarker of the Clinical High Risk for Schizophrenia","Inclusion Criteria:\n\n1. meeting Criteria of Psychosis-Risk Syndromes (COPS) criteria on the Structured Interview for Psychosis-Risk Syndromes (SIPS)\n2. capacity to provide informed consent\n3. if female, participant is not of child-bearing potential, defined as females who have undergone a sterilization procedure or have been post-menopausal for at least 1 year prior to screening OR participant is of child-bearing potential and agrees to use a medically approved method of birth control for the duration of the study\n\nExclusion Criteria:\n\n1. meeting criteria for any other DSM-5 diagnosis at the time of the study (except -personality disorder, nicotine use disorder, or other substance use disorder in full remission)\n2. concomitant or past neurological condition\n3. visual impairment which is not corrected to normal by prescription glasses history of reading disability\n4. past antipsychotic treatment at a therapeutic dose\n5. current treatment with a psychotropic medication except antidepressants on which the participants has been on a stable dose for at least 30 days.\n6. pregnancy (as identified on self-report and\u002For rapid urine pregnancy test) or intent to become pregnant according to self-report\n7. breastfeeding or plan to do so\n8. history of kidney stones\n9. current treatment with an antibiotic\n10. current treatment with nitroglycerin\n11. allergy to any ingredients in either the investigational product or placebo product",{"count":418,"type":22},90,[62],"Schizophrenia is a chronic debilitating psychotic disorder. Identifying persons with \"clinical high-risk\" (CHR) symptoms, which are like those of schizophrenia but less severe, and providing psychiatric care to these individuals has been shown to help prevent psychosis. Current medications used for CHR symptoms, however, are associated with substantial side effect burden. Therefore, practice guidelines do not recommend current medications as routine treatment for the CHR state, and there is a need to identify new treatments for this condition.\n\nResearch suggests that abnormal brain oxidative stress may contribute to schizophrenia, offering a potential novel treatment target in the CHR state. Oxidative stress is an excess of free radicals, which are generated from normal metabolism and environmental exposures, and can damage cells. Antioxidants in the body normally neutralize free radicals. Antioxidant deficiency could result in excess oxidative stress that damages brain cells, leading to schizophrenia. Recent studies suggest that N-acetylcysteine (NAC), a precursor of the most abundant brain antioxidant, glutathione, may be a safe, well-tolerated treatment for schizophrenia. In light of this, NAC may also reduce symptoms and brain abnormalities in CHR patients.",[422],"Prodromal Schizophrenia",[424,154,425,426,427,428,429],"psychosis","N-acetylcysteine","prodrome","mismatch negativity","event-related potentials","clinical high risk state","2026-03-24",{"date":330,"type":39},{"date":433,"type":39},"2023-01-13",{"date":435,"type":22},"2026-12-31",{"name":45,"class":46},{"id":438,"slug":4,"hasResults":11,"nctId":439,"briefTitle":440,"officialTitle":441,"acronym":442,"eligibilityCriteria":443,"healthyVolunteers":55,"sex":17,"minAge":90,"maxAge":145,"enrollmentInfo":444,"targetDuration":4,"studyType":60,"phases":446,"briefSummary":447,"conditions":448,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":449,"lastUpdatePostDateStruct":450,"startDateStruct":452,"completionDateStruct":454,"leadSponsor":456,"locationsCount":82},"100387532","NCT04325958","Age Differences in the Effects of Cannabis on Simulated Driving","The Influence of Age on Driving-related Cannabis Effects: Exploring Cannabis Use Frequency and Related Factors","ADCUF","Inclusion Criteria\n\n* 19-25 or 35-45 years of age;\n* Use of smoked cannabis at least once in the past 6 months.\n* Use of smoked or vaped cannabis primarily for recreational purposes on up to 1 day per week or on at least 6 days per week in the past 3 months;\n* Holds a class G or G2 Ontario driver's licence (or equivalent from another jurisdiction) for at least 12 months;\n* Willing to abstain from using alcohol for 24 hours and cannabis for 72 hours prior to Practice and Test Sessions;\n* Willing to abstain from all other drugs not prescribed for medical purposes for 48 hours prior to Practice and Test Sessions;\n* Resides within Toronto (study site) or can reside with friends\u002Ffamily in Toronto after a Test Session; this area may be extended to the Greater Toronto area if recruitment challenges arise;\n* Participant willing to use appropriate contraception until their participation in the study is completed;\n* Provides written and informed consent.\n\nExclusion Criteria\n\n* Use of cannabis primarily for therapeutic purposes, or equally for therapeutic and recreational purposes;\n* Diagnosis of medical condition that contraindicates use of cannabis determined by self-report as judged by the Principal Investigator and a study physician; this includes a history of hypersensitivity to cannabinoids smoke, respiratory disease and\u002For severe cardiovascular, cerebrovascular, renal or liver disease, and bleeding disorders. Smoking cannabis is not recommended for individuals with respiratory diseases, and they will be excluded;\n* Diagnosis of psychiatric condition that contraindicates use of cannabis determined by self-report or SCID-5;\n* Participants of childbearing potential: Pregnancy (point-of-care test) or breastfeeding;\n* Meets criteria for current or lifetime alcohol or other substance use disorder (DSM-5), except tobacco use disorder and caffeine use disorder;\n* Is a regular user of medications that affect brain function (based on self-report); this includes concomitant therapy with sedative-hypnotics or other psychoactive drugs\n* Use of anti-hypertensives;\n* First-degree relative diagnosed with schizophrenia or another psychotic disorder.\n* Participation in a past driving study at CAMH (to limit practice effects).\n* Participation in a clinical study concurrent with their participation in this study.",{"count":445,"type":22},128,[62],"Epidemiological studies suggest that the use of cannabis is associated with an increase in the risk of motor vehicle collisions. It is also known that younger users may be at increased risk for motor vehicle collisions. Further, the frequency with which cannabis is used may be an important variable in determining the effects of cannabis on driving. The purpose of the present study will be to investigate the effects of cannabis on simulated driving in young as compared to middle-aged drivers. Half of the participants will be occasional users of cannabis and half will be frequent users of cannabis.",[99],"2026-03-20",{"date":451,"type":39},"2026-03-23",{"date":453,"type":39},"2024-03-27",{"date":455,"type":22},"2027-03",{"name":45,"class":46},{"id":458,"slug":4,"hasResults":11,"nctId":459,"briefTitle":460,"officialTitle":461,"acronym":4,"eligibilityCriteria":462,"healthyVolunteers":11,"sex":17,"minAge":90,"maxAge":4,"enrollmentInfo":463,"targetDuration":4,"studyType":60,"phases":465,"briefSummary":466,"conditions":467,"keywords":469,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":474,"lastUpdatePostDateStruct":475,"startDateStruct":476,"completionDateStruct":478,"leadSponsor":480,"locationsCount":82},"100555461","NCT06512389","Evaluating Cannabidiol as a Novel Anticraving Medication for Alcohol Use Disorder","Evaluating Cannabidiol as a Novel Anticraving Medication for Alcohol Use Disorder: A Human Laboratory Study","Inclusion Criteria:\n\n* Meets DSM-5 criteria for AUD.\n* Meets drinking criteria of average weekly consumption \\> 10 standard drinks for women and \\> 15 standard drinks for men over the past 90 days.\n* Willing to take study medication and participate in laboratory sessions requiring self-administration of alcohol\n* Agrees not to use cannabis or illicit drugs during the study period.\n* Able to communicate and provide informed consent in English.\n* Alanine Aminotransferase (ALT) and Aspartate Transaminase (AST) level should not be more than 2 times the upper normal limit, and bilirubin should not be more than 1.5 times the upper normal limit.\n* Enrolled in the Ontario Health Insurance Plan (OHIP)\n* Willing and able to safely abstain from alcohol for at least 12 hours prior to the eligibility and alcohol self-administration visit.\n* Individuals who are capable of becoming pregnant: agree to the use of highly effective contraception during study participation and for an additional 28 days after the end of cannabidiol administration.\n\nExclusion Criteria:\n\n* Clinical Institute Withdrawal Assessment (CIWA-Ar) score of 10 or above upon initial assessment\n* History of severe alcohol withdrawal including withdrawal seizures, alcoholic hallucinosis, or delirium tremens\n* Any history of seizures\n* Serious unstable medical condition, including severe hepatic abnormalities\n* Having any clinical condition, drug sensitivity, or prior therapy which, in the investigator's opinion, makes the participant unsuitable for the study\n* Current medical conditions, prescriptions, or over the counter medications that interfere with receiving the study drug or alcohol (based on the study physician's assessment)\n* Severe mental illness (e.g. active psychosis with ongoing delusions and\u002For hallucinations, active manic or hypomanic episodes, evidence of a major neurocognitive disorder, etc.) and other substance use disorders (moderate or severe; excluding tobacco use disorder) as determined by the qualified investigator\n* Experiencing active suicidal ideation within the past 1 month and\u002For suicide attempt within the past 6 months\n* Recent recreational drug use (assessed via urine toxicology screen) other than alcohol and nicotine products\n* Current use of CBD products or use of CBD products within the past month.\n* History of hypersensitivity to CBD\n* Self-report of significant alcohol-induced flushing after 1-2 drinks (a proxy for aldehyde dehydrogenase deficiency)\n* Currently pregnant or breastfeeding or intending to become pregnant or breastfeed.\n* Currently institutionalized which refers to a person who lives in an institutional collective dwelling, such as a hospital, nursing home or prison, including a resident under custody (e.g., patient or inmate).\n* Currently in treatment for AUD (e.g. Alcoholics Anonymous, group therapy, individual therapy, on anticraving medication)",{"count":464,"type":22},36,[121],"This human laboratory study aims to assess the effects of cannabidiol on alcohol consumption and craving in participants with alcohol use disorder. In this double-blind within-subject placebo-controlled crossover trial, participants will be randomized to receive both cannabidiol and placebo with a 2-week washout period separating the two treatment phases.",[468],"Alcohol Use Disorder",[470,471,472,473],"alcohol use disorder","cannabidiol","alcohol consumption","craving","2026-03-19",{"date":449,"type":39},{"date":477,"type":39},"2024-08-16",{"date":479,"type":22},"2026-06-30",{"name":45,"class":46},{"id":482,"slug":4,"hasResults":11,"nctId":483,"briefTitle":484,"officialTitle":484,"acronym":4,"eligibilityCriteria":485,"healthyVolunteers":11,"sex":17,"minAge":56,"maxAge":4,"enrollmentInfo":486,"targetDuration":4,"studyType":60,"phases":488,"briefSummary":489,"conditions":490,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":474,"lastUpdatePostDateStruct":491,"startDateStruct":492,"completionDateStruct":494,"leadSponsor":495,"locationsCount":82},"100505002","NCT05855668","Phenotyping Patients With Alcohol and Cannabis Use Disorders Using the Addictions Neuroclinical Assessment","Inclusion Criteria:\n\n1. Patient has been referred to or intends to participate in either the AUD or CUD Integrated Care Pathway (and is therefore willing to participate in group psychotherapy).\n2. Able to communicate and provide informed consent in English.\n3. 18 years of age or older.\n4. Willing and able to safely abstain from substances (other than nicotine or tobacco products), including alcohol and cannabis, for 12 hours prior to the eligibility and task-based assessments.\n5. Meets DSM-5 diagnostic criteria for AUD (AUD group) or CUD (CUD group)\n6. Meets criteria for risky drinking, defined as \\> 10 drinks per week for females and \\> 15 drinks per week for males on average over the past 30 days (AUD group) or daily or near-daily cannabis use over the past 30 days, defined as ≥ 4 days of cannabis use per week on average (CUD group)\n\nExclusion Criteria:\n\n1. Active suicidal ideation at time of assessment.\n2. Suicide attempt within the past month.\n3. Unstable psychiatric or medical status (e.g., acute psychosis or mania) or unstable use of another substance that may interfere with participation in groups (e.g. active fentanyl use).\n4. Enrollment in another study that conflicts with the procedures or scientific integrity of this study.\n5. Individuals planning to be out of the province for a substantial amount of time during the treatment period will not be permitted to enroll.",{"count":487,"type":22},400,[62],"This 2-arm study will recruit participants with 1) alcohol use disorder and 2) cannabis use disorder for a 12-week cognitive behavioral therapy, following a thorough baseline assessments on executive function, incentive salience, and negative emotionality.",[468,376],{"date":449,"type":39},{"date":493,"type":39},"2022-11-10",{"date":282,"type":22},{"name":45,"class":46},{"id":497,"slug":4,"hasResults":11,"nctId":498,"briefTitle":499,"officialTitle":500,"acronym":501,"eligibilityCriteria":502,"healthyVolunteers":11,"sex":17,"minAge":56,"maxAge":117,"enrollmentInfo":503,"targetDuration":4,"studyType":60,"phases":504,"briefSummary":506,"conditions":507,"keywords":508,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":510,"lastUpdatePostDateStruct":511,"startDateStruct":512,"completionDateStruct":513,"leadSponsor":515,"locationsCount":82},"100572311","NCT06731621","Psilocybin for Treatment-Resistant Depression in Autism","Psilocybin for Treatment-Resistant Depression in Autism: a Pilot Trial With Pre-Post Brain and Cognitive Measurement to Understand Mechanism","PAT-DA","Inclusion Criteria:\n\n1. Must be aged 18 to 65 years old;\n2. Must be deemed to have capacity to provide informed consent;\n3. Ability to read and communicate in English;\n4. Must sign and date the informed consent form;\n5. Stated willingness to comply with all study procedures;\n6. Intellectually able: Either 1) the participant has a previous report showing intelligence quotient (IQ) ≥ 70 on the General Abilities Index of the Wechsler Adult Intelligence Scale-Fourth Edition (WAIS-IV) or any other standardized intelligence scales, or 2) the participant scores \\>10 percentile on the nine-item form of the Raven's Standard Progressive Matrices Test (RSPM).\n7. Clinical diagnosis of autism spectrum disorder (ASD), based on the DSM-5 or ICD-11\n8. Primary DSM-5 diagnosis of non-psychotic MDD, single or recurrent, based on the Mini International Neuropsychiatric Interview (MINI) administered at the first screening visit (V1);\n9. Participants diagnosed with treatment-resistant depression defined as individuals with a baseline GRID-HAMD-17 score \\> 14 and that have not responded to two or more separate trials of antidepressants at an adequate dosage and duration based on the Antidepressant Treatment History Form; there is no upper limit on the number of treatment failures;\n10. Ability to take oral medication;\n11. Individuals who are capable of becoming pregnant: use of highly effective contraception for at least 3 months prior to screening and agreement to use such a method during study participation;\n12. Individuals who are willing to taper off current antidepressant and antipsychotic medications for a minimum of 2-weeks (or more depending on the medication) prior to Baseline (V2) and whose physician confirms that it is safe for them to do so; and\n13. A clean urine drug screen and negative urine pregnancy test (in females).\n14. Agreement to adhere to Lifestyle Considerations (see below) throughout study duration\n\nExclusion Criteria:\n\n1. Pregnant as assessed by a urine pregnancy test or individual's that intend to become pregnant during the study or are breastfeeding;\n2. Treatment with another investigational drug or other intervention within 30 days of Screening (V1);\n3. The presence of an unstable seizure disorder as defined by having not been seizure-free for at least 6 months or anticonvulsant treatment has not been stable for at least 4 weeks;\n4. The presence of any clinically significant or unstable medical conditions, including cardiovascular, liver, kidney, pulmonary disease, presence of known congenital brain malformation, as per investigator assessment based on medical history and chart review;\n5. Moderate or severe DSM-5 diagnosis of an alcohol or substance use disorder in the past 12 months;\n6. Any DSM-5 lifetime diagnosis of a schizophrenia-spectrum disorder, psychotic disorder (unless substance induced or due to a medical condition), bipolar I or II disorder, paranoid personality disorder, or neurocognitive disorder as determined by medical history and the MINI clinical interview;\n7. Any first-degree relative with a diagnosis of schizophrenia-spectrum disorder; psychotic disorder (unless substance-induced or due to a medical condition); or bipolar I or II disorder as determined by the family medical history form and discussions with the participant;\n8. Presence of a relative or absolute contraindication to psilocybin, including a drug allergy, recent stroke history, uncontrolled hypertension, low or labile blood pressure, recent myocardial infarction, cardiac arrhythmic, severe coronary artery disease, or moderate to severe renal or hepatic impairment;\n9. Substantial lifetime use (\\>10 years total) or recent use (past 6 months) of ketamine, psychedelics, or MDMA and positive urine toxicological screen at Screening (V1) and Baseline (V2);\n10. Any other clinically significant physical illness, including chronic infectious diseases or any other major concurrent illness that, in the opinion of the investigator, may interfere with the interpretation of the study results or constitute a health risk for the participant if they take part in the study;\n11. Have active suicidal ideation with intent and plan as determined by SBQ-ASC.\n12. Have initiated new psychotherapy within 12 weeks prior to Screening\n13. Contraindication to MR imaging or a previous history of claustrophobia.\n\nLifestyle considerations:\n\nDuring this clinical trial, participants are asked to:\n\n* Abstain from alcohol for 24 hours before the intervention or the day of the intervention (V3, V4).\n* Abstain from the use of any prescribed opioids, benzodiazepines, or sleep aids (Z-drugs) within 12 hrs prior to the intervention (V3, V4) and for up to 6 hrs after administration.\n* Abstain from any illicit drugs (e.g. cocaine, ecstasy\u002FMDMA, hallucinogens) for the duration of the study.\n* Abstain from any cannabinoids within 3 weeks prior to the intervention (V3, V4) and until the completion of the 2nd integrative therapy session (V6).\n* Abstain from driving or operating heavy machinery for up to 24 hours after the intervention (V3, V4).",{"count":147,"type":22},[505],"PHASE1","We propose a first-of-its-kind open-label clinical trial to investigate the feasibility, tolerability, and safety of administering psilocybin in autistic adults with treatment-resistant depression (TRD). In this study, 20 participants (intellectually able and fluent-speech adults) with autism and co-occurring TRD will receive around 20 hours of manualized psychotherapy that has previously been used with psilocybin (Agin-Liebes et al., 2020). They will also receive psilocybin at 2 different time points, firstly a safety dose of 10mg, followed by a treatment dose of 25mg. This study design is in accordance with previous studies investigating the use of psilocybin with psilocybin-assisted therapy (PAT) to treat TRD (Carhart-Harris et al., 2016, 2018)",[124,65],[124,65,509],"psilocybin-assisted therapy","2026-03-18",{"date":449,"type":39},{"date":220,"type":39},{"date":514,"type":22},"2027-08",{"name":45,"class":46},{"id":517,"slug":4,"hasResults":11,"nctId":518,"briefTitle":519,"officialTitle":520,"acronym":521,"eligibilityCriteria":522,"healthyVolunteers":11,"sex":17,"minAge":56,"maxAge":4,"enrollmentInfo":523,"targetDuration":4,"studyType":60,"phases":525,"briefSummary":526,"conditions":527,"keywords":531,"overallStatus":537,"whyStopped":4,"lastUpdateSubmitDate":538,"lastUpdatePostDateStruct":539,"startDateStruct":540,"completionDateStruct":542,"leadSponsor":544,"locationsCount":4},"100614044","NCT07274475","Smoking Harm Reduction Using E-cigarettes and Cytisine","Exploring Alternative Approaches to Harm Reduction and Cessation for Treatment-Resistant Tobacco Dependence","SHRECC","Inclusion Criteria:\n\n1. Willingness to comply with all study procedures, for the full duration of the study period (12 months);\n2. Age 18 years or older;\n3. Currently smoking 5 or more cigarettes daily; and\n4. Must have regular access to a phone and email to receive study communications and complete study monitoring.\n\nExclusion Criteria:\n\n1. Individuals who smoke only occasionally or have quit smoking prior to the 6-month follow-up;\n2. Daily or almost daily users of e-cigarettes for the past 30 days;\n3. Presence of medical or psychiatric conditions that may interfere with safe participation or compliance with the study protocol, including severe cardiovascular disorders, renal impairment or respiratory conditions;\n4. Known allergy or hypersensitivity to any components of the e-cigarettes, e-liquids, or cytisine;\n5. Pregnant or breastfeeding, or planning to become pregnant within the next 12 months; or\n6. Current use of pharmacological smoking cessation aids or participation in other smoking cessation clinical trials.",{"count":524,"type":22},6000,[62],"Smoking remains the leading cause of preventable death globally, with high prevalence in disadvantaged populations despite access to free nicotine replacement therapy (NRT) and counseling through Ontario's STOP Program. This study aims to evaluate the acceptability, feasibility, and comparative effectiveness of e-cigarettes and cytisine as harm-reduction tools for individuals who continue to smoke despite standard treatments. Over four years, 6,000 STOP participants who smoke ≥5 cigarettes daily at six months post-treatment will be randomized to receive either an e-cigarette starter kit or a 28-day cytisine supply. Data will be collected via REDCap and include biomarkers (NNAL, PAH), self-reported smoking behavior, nicotine dependence, and quality of life. Statistical analyses will assess changes and compare outcomes between groups. Results will inform public health strategies and enhance equitable cessation support for underserved populations.",[528,529,530],"Tobacco Smoking","Harm Reduction","Nicotine",[532,533,534,535,207,536],"Cytisine","E-cigarettes","Smoking cessation","treatment-resistant","Clinical intervention","NOT_YET_RECRUITING","2026-03-17",{"date":474,"type":39},{"date":541,"type":22},"2026-05-01",{"date":543,"type":22},"2028-03",{"name":45,"class":46},{"id":546,"slug":4,"hasResults":11,"nctId":547,"briefTitle":548,"officialTitle":549,"acronym":4,"eligibilityCriteria":550,"healthyVolunteers":11,"sex":17,"minAge":56,"maxAge":117,"enrollmentInfo":551,"targetDuration":4,"studyType":60,"phases":552,"briefSummary":553,"conditions":554,"keywords":557,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":538,"lastUpdatePostDateStruct":560,"startDateStruct":561,"completionDateStruct":563,"leadSponsor":565,"locationsCount":82},"100584151","NCT06885606","The Use of tDCS for Vaping Reduction","Using Transcranial Direct Current Stimulation (tDCS) for Vaping Reduction in Daily E-cigarette Users: a Pilot Study","Inclusion Criteria:\n\n* The participant must meet all of the inclusion criteria to be eligible for this research study:\n\n  1. Be able to provide informed written consent\n  2. Stated willingness to comply with all study procedures\n  3. Age 18 - 65 years\n  4. Is a daily regular use of nicotine-containing e-cigarette for at least the past 6 months\n  5. Is willing to attend daily appointments for tDCS for two consecutive weeks (Monday through Friday)\n  6. Is not interested in or planning to quit vaping in the next 30 days.\n\nExclusion Criteria:\n\n* An individual who meets any of the following criteria will be excluded from participation in this research study:\n\n  1. Substance use disorder (other than nicotine dependence) (M.I.N.I. SCID) (confirmed with urine drug screen)\n  2. Current regular use of tobacco cigarettes, nicotine replacement therapy or other medications for smoking cessation\n  3. Unstable psychiatric condition\n  4. Recent clinically significant head trauma\\*\n  5. History of seizures and\u002For epilepsy\\*\n  6. Pacemakers or implanted electrical devices such as cochlear implants\\*\n  7. Metal embedded in the skull\\*\n  8. Skin lesions, open wounds, bruising, or similar injuries on the scalp\\*",{"count":317,"type":22},[62],"Project Summary - tDCS for Vaping Reduction\n\nBackground: While the prevalence of tobacco smoking has plateaued over the last several years, the prevalence of nicotine vaping (e-cigarettes) continues to increase exponentially in Canada. Originally touted as a safe alternative to smoking, e-cigarette use or vaping is now most popular among youth and young adults. The high prevalence of e-cigarette use, coupled with growing evidence of associated harms and reports of addiction and difficulties in quitting reinforces the urgent need to develop and test methods to attenuate e-cigarette craving as a step towards developing approaches to vaping cessation that are brief, inexpensive and effective. Non-invasive brain stimulation techniques have become a popular area of research as a treatment option for substance use disorders with growing evidence of their effectiveness for a variety of addictions. One of these techniques, transcranial direct current stimulation (tDCS), has been shown to decrease cigarette craving and consumption. Thus, the purpose of this pilot study is to evaluate the effectiveness of using tDCS for vaping reduction in e-cigarette users.\n\nMethods: This will be a double-blind sham-controlled randomized trial whereby 40 daily nicotine-containing e-cigarette users will be recruited to undergo 10 consecutive daily sessions of tDCS (Monday to Friday for 2 weeks). Participants will be randomized (1:1) to either sham (0mA) or active tDCS (2mA), with the anode at the left dorsolateral prefrontal cortex (DLPFC) and cathode at the right DLPFC. The primary outcome is vaping frequency (puffs\u002Fday and nicotine pods\u002Fweek) at end of treatment (2 weeks). The secondary outcome will be e-cigarette craving. Participants will be followed-up via the phone at 1 month and 3 months post randomization respectively.\n\nImplication: This will be the first treatment study to target vaping reduction. There are currently no established treatment options for e-cigarette addiction and medications traditionally used for smoking cessation only address withdrawal symptoms and not addiction pathology. Thus, findings from this study may be used to inform future designs of vaping reduction strategies or vaping cessation.",[555,207,556],"Vaping","Transcranial Direct Current Stimulation(tDCS)",[533,555,558,559,530],"Brain stimulation","tDCS",{"date":474,"type":39},{"date":562,"type":39},"2026-01-01",{"date":564,"type":22},"2026-05",{"name":45,"class":46},{"id":567,"slug":4,"hasResults":11,"nctId":568,"briefTitle":569,"officialTitle":570,"acronym":571,"eligibilityCriteria":572,"healthyVolunteers":11,"sex":342,"minAge":56,"maxAge":57,"enrollmentInfo":573,"targetDuration":4,"studyType":60,"phases":575,"briefSummary":576,"conditions":577,"keywords":581,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":538,"lastUpdatePostDateStruct":589,"startDateStruct":590,"completionDateStruct":592,"leadSponsor":593,"locationsCount":82},"100478851","NCT05515354","Smoking Cessation and Menstrual Cycle Phase","Coordinating Smoking Cessation Treatment With Menstrual Cycle Phase to Improve Quit Outcomes: A Randomized Controlled Trial","MC-NRT","Inclusion Criteria:\n\n* Must provide informed consent following the CAMH REDCap e-consent framework and procedures;\n* Stated willingness to comply with all study procedures;\n* Naturally cycling individuals with regular MCs (defined as length ranging 21 to 35 days over past 6 months);\n* Daily smoker of ≥5 cigarettes per day (CPD) over past 6 months;\n* Intention to quit smoking within the next 30 days and willing to make a quit attempt on their assigned TQD;\n* Interested in using, and able to use, nicotine patches and gum or lozenge as a smoking cessation aid;\n* Willing to provide a valid e-mail address to be used for study communications and to complete online questionnaires.\n\nExclusion Criteria:\n\n* Current use of progesterone, estrogen, testosterone, or fertility treatment;\n* Current use of nicotine replacement therapy or other smoking cessation medications (e.g., varenicline, bupropion);\n* Use of hormonal contraceptives in the past 6 months (e.g., pill, patch, hormonal intrauterine device \\[IUD\\], ring);\n* Pregnancy, or trying to become pregnant in the next 2-3 months;\n* Known hypersensitivity or allergies to any of the components of the nicotine patch;\n* Daily or almost daily use of cannabis in the past 6 months;\n* Daily or almost daily use of tobacco or nicotine products other than cigarettes (e.g., smokeless tobacco, heat-not-burn products, e-cigarettes) in the past 6 months;\n* Polycystic ovary syndrome diagnosis;\n* Unstable psychiatric condition (including substance use disorder) which would compromise study compliance;\n* Life threatening arrhythmias or severe\u002Fworsening angina pectoris;\n* Myocardial infarction or cerebral vascular accident in the past 2 weeks; or\n* Diagnosed with a terminal illness.",{"count":574,"type":22},1200,[233],"Tobacco use is a risk factor for at least 20 types of cancer and remains the leading preventable cause of cancer in Canada. Smoking cessation is an important cancer prevention strategy for the close to 2 million Canadian women who currently smoke. However, findings from controlled trials and real-world clinical settings indicate that women have greater difficulty achieving abstinence following a quit attempt than men. There is some evidence that hormonal levels and fluctuations throughout the menstrual cycle (MC) may contribute to the greater difficulty women experience when trying to quit smoking. In this study, the start of a quit attempt using nicotine replacement therapy (NRT) will be targeted to specific phases of MC. It was hypothesized that starting a quit attempt during the first half of MC (follicular phase) will result in increased quit success compared to starting during the second half of MC (luteal phase) or the usual practice of not targeting quit start date to MC phase.",[578,528,579,580,182],"Nicotine Dependence","Smoking Cessation","Nicotine Use Disorder",[349,582,583,584,585,586,587,588],"Ovarian Hormones","Smoking Cessation Treatment","Nicotine Replacement Therapy","Cancer Prevention","Randomized Controlled Trial","Estrogen","Progesterone",{"date":474,"type":39},{"date":591,"type":39},"2022-11-30",{"date":435,"type":22},{"name":45,"class":46},{"id":595,"slug":4,"hasResults":11,"nctId":596,"briefTitle":597,"officialTitle":598,"acronym":599,"eligibilityCriteria":600,"healthyVolunteers":11,"sex":17,"minAge":394,"maxAge":289,"enrollmentInfo":601,"targetDuration":4,"studyType":60,"phases":603,"briefSummary":604,"conditions":605,"keywords":607,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":538,"lastUpdatePostDateStruct":612,"startDateStruct":613,"completionDateStruct":615,"leadSponsor":617,"locationsCount":82},"100437120","NCT04972136","rTMS for Depression in Young Adults With Autism","A Double-Blind Randomized Controlled Trial Evaluating the Efficacy of Repetitive Transcranial Magnetic Stimulation (rTMS) as Treatment for Major Depressive Disorder in Transition-Age Youth With Autism Spectrum Disorder","rTMS-MDD","Inclusion Criteria:\n\n* Fluent in English\n* ASD diagnosis confirmed by the clinician\u002Fclinical team, and IQ\\> or =70\n* Able to participate in the informed consent process, provide voluntary informed consent and provide a spontaneous narrative description of the key elements of the study\n* Clinical stability: determined by a physician, no switch of psychotropic medications or increase in dosage in the last 30 days; no change in other therapeutic interventions in last 30 days\n* BDI-II score ≥21 that is sustained over a lead-in period of two weeks\n* Global Assessment of Function (GAF) scores (≤60) that is sustained over a lead-in period of two weeks AND\u002FOR VABS-III below adequate functioning at baseline assessment.\n\nExclusion Criteria:\n\n* A history of a DSM-5 substance use disorder (other than tobacco) within the past six months; or a positive baseline urine drug screen\n* Significantly debilitating medical or neurologic illness, or acute or unstable medical illnesses as determined by study physician\n* Metal implants or a pace-maker, claustrophobia that would preclude the MRI scan\n* Actively suicidal (i.e., suicidal ideation with plan and intent) or high risk for suicide as assessed by a study psychiatrist\n* History of seizures\n* Taking benzodiazepines at a dose greater or equal to 2mg Lorazepam or any anticonvulsant medication\n* Prior rTMS treatment\n* Pregnancy",{"count":602,"type":22},80,[62],"The current clinical trial is focused on evaluating the efficacy of rTMS for treatment of depression in youth and young adults (hereafter called transition aged youth, TAY) with autism spectrum disorder (ASD). The motivation to undertake the current efficacy study is driven by: (1) the substantial impact of depression on TAY with ASD (based on prevalence and contribution to disability\u002Fimpairment); (2) lack of evidence-based treatments for depression in autism (there are no current trials rigorously evaluating any treatment for depression, i.e., psychotherapeutic, pharmacotherapeutic, brain stimulation); (3) rTMS has demonstrated efficacy in non-autistic individuals to improve symptoms of depression and may be better tolerated in youth than medication treatment; (4) a prior pilot rTMS study focused on treatment of executive function deficits in autism indicated that high frequency rTMS delivered using a rigorous randomized control trial (RCT) protocol can be feasibly implemented in TAY with autism, is well tolerated (mild to moderate adverse effects and low drop out), and has the potential to improve symptoms of depression.",[65,606],"Major Depressive Disorder",[65,606,608,609,610,611],"rTMS (Repetitive Transcranial Magnetic Stimulation)","MRI (Magnetic Resonance Imaging)","Suicidal and Self-Injurious Behaviour","Adaptive Functioning",{"date":474,"type":39},{"date":614,"type":39},"2021-01-14",{"date":616,"type":22},"2027-01-14",{"name":45,"class":46},{"id":619,"slug":4,"hasResults":11,"nctId":620,"briefTitle":621,"officialTitle":622,"acronym":623,"eligibilityCriteria":624,"healthyVolunteers":11,"sex":17,"minAge":56,"maxAge":315,"enrollmentInfo":625,"targetDuration":4,"studyType":60,"phases":626,"briefSummary":627,"conditions":628,"keywords":630,"overallStatus":537,"whyStopped":4,"lastUpdateSubmitDate":632,"lastUpdatePostDateStruct":633,"startDateStruct":634,"completionDateStruct":636,"leadSponsor":638,"locationsCount":639},"100609198","NCT07211438","Evaluating the Role of Psilocybin Monitors in Psilocybin Therapy for Treatment Resistant Depression","Evaluating the Role of Psilocybin Monitors in Psilocybin Therapy for Treatment Resistant Depression: A Pilot Randomized Clinical Trial","PSI-TNT","Inclusion Criteria:\n\n1. Adults 18 to 70 years old;\n2. Are outpatients;\n3. Must be deemed to have capacity to provide informed consent;\n4. Must read, sign and date the informed consent form independently. Proxy consent, including consent from a Legally Authorized Representative (LAR), is not permitted in this study;\n5. Stated willingness to comply with all study procedures;\n6. Ability to read and communicate in English, such that their literacy and comprehension is sufficient for understanding the consent form and study questionnaires, as evaluated by study staff obtaining consent\n7. Primary DSM-5 diagnosis of non-psychotic MDD, single or recurrent, and current Major Depressive Episode (MDE) based on the Mini-International Neuropsychiatric Interview (MINI) for DSM-5 administered at the first screening visit;\n8. Participants diagnosed with treatment-resistant depression defined as individuals with a baseline HamD-17 score \\> 14 and that have not responded to two or more separate trials of antidepressants at an adequate dosage and duration (an antidepressant resistance rating score of three or more is considered an adequate trial) based on the Antidepressant Treatment History Form (ATHF) (Sackeim \\& Sackeim, 2001); there is no upper limit on the number of treatment failures;\n9. Ability to take oral medication;\n10. Individuals with an eGFR above 40mL\u002Fmin\u002F1.73m2 and all blood work on clinical laboratory tests assessed as not clinically significant by study delegate physician at Screening (V1)\n11. Individuals who are capable of making their partner pregnant or who are capable of becoming pregnant: use of condoms or highly effective contraception for at least 1 month prior to screening and agreement to use such a method during study participation;\n12. Individuals who are willing to and tapered off current antidepressants, antipsychotics, mood stabilizers, ketamine, esketamine, monoaminergic medicines, and stimulants used for augmentation of antidepressant therapy for a minimum of 2-weeks (or more depending on the medication) prior to Baseline (V2) and for the duration of the study and whose prescribing physician confirms that it is safe for them to do so;\n13. Individuals who are willing to and have tapered off current inhibitors of 5'-diphospho-glucuronosyltransferase (UGT)1A9 and 1A10, aldehyde dehydrogenase inhibitors (ALDHs) and alcohol dehydrogenase inhibitors (ADHs) for a minimum of 2-weeks (or more depending on the medication) prior to Baseline (V2) and for the duration of the study and whose physician confirms that it is safe for them to do so;\n14. Individuals must have a designated caregiver who is able to bring them home after treatment sessions and stay with them for at least 24 hours after psilocybin has been administered;\n15. Individuals who are willing to not receive additional psychotherapy outside of the study throughout the active duration of the study; AND\n16. Agreement to adhere to Lifestyle Considerations (section 4.5) throughout study duration.\n\nExclusion Criteria:\n\nAn individual who meets any of the following criteria will be excluded from participation in this clinical trial:\n\n1. Pregnant as assessed by a urine pregnancy test at Screening (V1) and Baseline (V2) or individual's that intend to become pregnant during the study or are breastfeeding;\n2. Treatment with another investigational drug or other intervention within 30 days of Screening (V1);\n3. Brain stimulation treatment within 6 months of Screening (V1);\n4. Use of psychedelics within 6 months of Screening (V1);\n5. Have initiated psychotherapy in the preceding 4 weeks prior to Screening (V1);\n6. Have a DSM-5 diagnosis of moderate to severe substance use disorder (recreational use of tobacco, alcohol, cannabis and prescribed opioids are permitted) within the preceding 6 months;\n7. Have active suicidal ideation with intent and plan, certified by the Mental Health Act (MHA), determined by a study physician;\n8. Any DSM-5 lifetime diagnosis of mania or hypomania, a schizophrenia-spectrum disorder, obsessive-compulsive disorder, psychotic disorder (unless substance induced or due to a medical condition), bipolar I or II disorder, paranoid personality disorder, borderline personality disorder, or neurocognitive disorder as determined by medical history and the MINI diagnostic interview;\n9. Any first-degree relative with a diagnosis of schizophrenia-spectrum disorder; psychotic disorder (unless substance-induced or due to a medical condition), as determined by the family medical history form and discussions with the participant;\n10. Presence of a relative or absolute contraindication to psilocybin, including a drug allergy, recent stroke history (within preceding six months) , uncontrolled hypertension (consistent blood pressure readings above 160\u002F100 mmHg: measured twice with one hour between measurements), low blood pressure (blood pressure reading lower than 90\u002F60mmHg), labile blood pressure (defined as episodes of both high and low blood pressure within a 24-hour period), recent myocardial infarction (within preceding six months), all types of cardiac arrhythmia, severe coronary artery disease (symptomatic with chest pain, angina heart palpitations or shortness of breath), or moderate to severe renal impairment (eGFR of below 40 mL\u002Fmin ) or hepatic impairment (as a Child-Pugh score of B or C, determined through liver function tests);\n11. Presence of baseline prolonged QTc (defined as greater than 450 milliseconds (ms) in men and greater than 460 ms in women) or Torsade de Pointes as measured by the ECG or a history of long QTc syndrome or related risk factors ;\n12. Any other clinically significant physical illness including chronic infectious diseases or any other major concurrent illness that, in the opinion of the investigator, may interfere with the interpretation of the study results or constitute a health risk for the participant if they take part in the study.",{"count":317,"type":22},[121],"Psilocybin, the chemical component of \"magic mushrooms\", has been administered with psychological support in several randomized clinical trials (RCTs) showing large and sustained antidepressant effects.\n\nThe purpose of this study is to determine the role of psilocybin monitors on the effects of psilocybin therapy in adults with treatment resistant depression.",[629],"Treatment-Resistant Depression",[126,127,631,128],"Treatment resistant depression","2026-03-16",{"date":510,"type":39},{"date":635,"type":22},"2026-04-01",{"date":637,"type":22},"2028-12-01",{"name":45,"class":46},2,{"id":641,"slug":4,"hasResults":11,"nctId":642,"briefTitle":643,"officialTitle":643,"acronym":644,"eligibilityCriteria":645,"healthyVolunteers":11,"sex":17,"minAge":646,"maxAge":647,"enrollmentInfo":648,"targetDuration":4,"studyType":60,"phases":650,"briefSummary":651,"conditions":652,"keywords":659,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":632,"lastUpdatePostDateStruct":664,"startDateStruct":665,"completionDateStruct":667,"leadSponsor":668,"locationsCount":82},"100544791","NCT06373484","Matching Assessment and Treatment for Children With Disruptive Behaviour and Their Parents","MATCH-DB","Inclusion Criteria:\n\n* Child is borderline\u002Fclinically at risk on the Child Behaviour Checklist (CBCL) or Teacher Report Form (TRF) (T-score greater than or equal to 60 on Externalizing Problems composite scale or a T-score greater than or equal to 65 on the Oppositional Defiant Disorder and\u002For Conduct Disorder scales)\n* Child has clinically severe impairment in the interpersonal relations (greater than 3), functioning in schoolwork (greater than 3), or total domains (greater than 15) on the Columbia Impairment scale.\n* Parent is able and willing to participate in a group treatment\n\nExclusion Criteria:\n\n* Child has an ongoing query or diagnosis of Pervasive Developmental Disorder or Autism or Asperger's Disorder\n* Evidence of cognitive delays or an intellectual disability (based on the Kauffman Brief Intelligence Test-2 (KBIT-2), verbal and\u002For IQ composite standard score below 80 or collateral information)\n* Child behaviour or emotional functioning that make group participation not possible\n* Child preference for individual treatment.\n* Parent behaviour or emotional functioning that make group participation not possible\n* Parent preference for individual treatment.","6 Years","12 Years",{"count":649,"type":22},200,[62],"This study will develop and test whether personalized profiles of children with Disruptive Behaviour Disorder (DBD) and their parents based on important psychological, emotional, and neuropsychological indicators predict their response to child cognitive behavioral treatment and Behavioral Parent Training.",[653,654,655,656,657,658],"Disruptive Behavior Disorder","Emotional Disorder","Behavioural Disorder","Attention Deficit Hyperactivity Disorder","Conduct Disorder","Oppositional Defiant Disorder",[660,661,656,657,658,662,663],"Emotional and Behavioural Disorders","Disruptive Behaviour Disorder","Parenting Skills","Behavioural Parenting Training",{"date":538,"type":39},{"date":666,"type":39},"2022-10-01",{"date":137,"type":22},{"name":45,"class":46},""]