[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100486629":3},{"organization":4,"armGroups":7,"interventions":22,"overallOfficials":28,"centralContacts":37,"locations":46,"responsibleParty":68,"collaborators":71,"id":78,"slug":10,"hasResults":79,"nctId":80,"briefTitle":81,"officialTitle":82,"acronym":83,"eligibilityCriteria":84,"healthyVolunteers":79,"sex":85,"minAge":86,"maxAge":87,"enrollmentInfo":88,"targetDuration":91,"studyType":92,"phases":10,"briefSummary":93,"conditions":94,"keywords":100,"overallStatus":48,"whyStopped":10,"lastUpdateSubmitDate":113,"lastUpdatePostDateStruct":114,"startDateStruct":117,"completionDateStruct":119,"leadSponsor":121,"locationsCount":122},{"fullName":5,"class":6},"Rigshospitalet, Denmark","OTHER",[8,14,18],{"label":9,"type":10,"description":11,"interventionNames":12},"Patient cohort (n=800)",null,"All participants included will contribute with basic clinical, cognitive, psychometric, genetic and biochemical data.",[13],"Combination Product: Treatment Package for First-Episode Depression",{"label":15,"type":10,"description":16,"interventionNames":17},"Subcohort I (n=600)","Patients in Subcohort I undergo MRI and EEG in addition to expanded clinical, cognitive, psychometric, and biological data.",[13],{"label":19,"type":10,"description":20,"interventionNames":21},"Subcohort II - drug naive PET subgroup (n=60)","A subgroup of Subcohort I, including only patients who at inclusion do not receive any pharmacological treatment for their depression, undergo in addition Positron Emission Tomography imaging with \\[11C\\]-UCB-J for measurement of cerebral synaptic density.",[13],[23],{"type":24,"name":25,"description":26,"armGroupLabels":27,"otherNames":10},"COMBINATION_PRODUCT","Treatment Package for First-Episode Depression","The outpatient 'treatment package' for first episode depression is a national uniform package designed by Mental Health Services in the Capital Region. The treatment package for first-episode depression is a program with manualized group CBT, psychoeducation of patients and relatives, and relapse prevention. Antidepressant medication and individual psychotherapy are available as needed.",[9,15,19],[29,33],{"name":30,"affiliation":31,"role":32},"Martin B Jørgensen, DMSc","Psychiatric Center Copenhagen","PRINCIPAL_INVESTIGATOR",{"name":34,"affiliation":35,"role":36},"Gitte MK Knudsen, DMSc","Neurobiology Research Unit, Rigshospitalet","STUDY_DIRECTOR",[38,43],{"name":39,"role":40,"phone":41,"phoneExt":10,"email":42},"Kristian HR Jensen, MD","CONTACT","+45 35456720","kristian.reveles.jensen@nru.dk",{"name":30,"role":40,"phone":44,"phoneExt":10,"email":45},"+45 38647082","Martin.Balslev.Joergensen@regionh.dk",[47],{"facility":35,"status":48,"city":49,"state":10,"zip":50,"country":51,"countryCode":52,"cosmosGeoPoint":53,"geoPoint":58,"contacts":59},"RECRUITING","Copenhagen","2100","Denmark","DK",{"type":54,"coordinates":55},"Point",[56,57],12.56553,55.67594,{"lat":57,"lon":56},[60,64,66],{"name":61,"role":40,"phone":62,"phoneExt":10,"email":63},"Gitte M Knudsen, Professor","+45 3545 6712","gitte@nru.dk",{"name":65,"role":32,"phone":10,"phoneExt":10,"email":10},"Martin B Jørgensen, PhD",{"name":39,"role":67,"phone":10,"phoneExt":10,"email":10},"SUB_INVESTIGATOR",{"type":32,"investigatorFullName":69,"investigatorTitle":70,"investigatorAffiliation":5,"oldNameTitle":10,"oldOrganization":10},"Gitte Moos Knudsen","MD,Professor",[72,74,76],{"name":73,"class":6},"Mental Health Centre Copenhagen, Bispebjerg and Frederiksberg Hospital",{"name":75,"class":6},"Center for Integrated Molecular Brain Imaging, Copenhagen, Denmak",{"name":77,"class":6},"Lundbeck Foundation","100486629",false,"NCT05616559","Precision Medicine in the Depression Treatment","The BrainDrugs-Depression Study: A Prospective Precision Psychiatry Cohort Study in the Treatment of Depression","BDD","Inclusion Criteria:\n\n* Age between 18 and 65 years\n* Fulfilment of International Classification of Diseases version 10 diagnostic criteria for a primary depressive episode (i.e., not secondary to known organic or other psychiatric disorder).\n* Referral to a treatment package for single-episode depression.\n\nExclusion Criteria:\n\n* Psychosis or psychotic symptoms\n* History of severe head trauma\n* Somatic disease associated with morphological brain changes (e.g., brain tumour)\n* Insufficient Danish language skills to complete questionnaires and cognitive testing\n\nAdditional exclusion criteria for Cohort II:\n\n* Severe somatic disease\n* Contraindications for MRI (e.g., metal implants, claustrophobia or back problems)\n\nAdditional exclusion criteria for Cohort III:\n\n* Severe somatic disease\n* Contraindications for MRI\n* Exposure to radioactivity \\>10 mSv within the last year\n* Pregnancy or breastfeeding\n* Use of psychotropic drugs","ALL","18 Years","65 Years",{"count":89,"type":90},800,"ESTIMATED","18 Months","OBSERVATIONAL","The BrainDrugs-D study uses multimodal neuroimaging combined with self-report measures, clinical and molecular markers to identify clinically relevant predictors that can identify subtypes of major depressive disorder (MDD) and, in a naturalistic setting, predict treatment response to standard antidepressive treatment. The cohorts are followed in nationwide health registries.",[95,96,97,98,99],"Depressive Disorder, Major","Treatment Outcome","Cognitive Dysfunction","Cognitive Behavioral Therapy","Antidepressive Agents",[101,102,103,104,105,106,107,108,109,110,111,112],"PET","MRI","fMRI","EEG","Prediction of treatment response","Early life stress","Selective Serotonin Reuptake Inhibitor","Psychometrics","MDD","Cold cognition","Social cognition","Anxiety","2024-10-03",{"date":115,"type":116},"2024-10-08","ACTUAL",{"date":118,"type":116},"2021-06-15",{"date":120,"type":90},"2026-12",{"name":5,"class":6},1]