[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100423135":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":31,"centralContacts":36,"locations":42,"responsibleParty":62,"collaborators":66,"id":71,"slug":72,"hasResults":73,"nctId":74,"briefTitle":75,"officialTitle":76,"acronym":77,"eligibilityCriteria":78,"healthyVolunteers":79,"sex":80,"minAge":81,"maxAge":82,"enrollmentInfo":83,"targetDuration":26,"studyType":86,"phases":87,"briefSummary":89,"conditions":90,"keywords":93,"overallStatus":45,"whyStopped":26,"lastUpdateSubmitDate":96,"lastUpdatePostDateStruct":97,"startDateStruct":100,"completionDateStruct":102,"leadSponsor":104,"locationsCount":105},{"fullName":5,"class":6},"University of Copenhagen","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Memantine + aripiprazole","ACTIVE_COMPARATOR","Tablet memantine or placebo will be initiated at 10mg\u002Fday for 1 week, hereafter the dose will be increased to 20mg\u002Fday until end of trial. The tablets will be identical and be provided in 10mg tablets or 20 mg tablets. (12 weeks of treatment).\n\nTablet aripiprazole will be administered in doses starting at 5-10 mg\u002Fday. Doses will be increased slowly according to effect and side effects up to 30 mg\u002Fday.",[13],"Drug: Memantine",{"label":15,"type":16,"description":17,"interventionNames":18},"Placebo + aripiprazole","PLACEBO_COMPARATOR","Coated placebo tablets will be provided to match memantine. Placebo equivalent of 10mg\u002Fday for 1 week, hereafter the dose will be increased to 20mg\u002Fday until end of trial. (12 weeks of treatment).\n\nTablet aripiprazole will be administered in doses starting at 5-10 mg\u002Fday. Doses will be increased slowly according to effect and side effects up to 30 mg\u002Fday.",[19],"Drug: Placebo",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","Memantine","Add on treatment with memantine to aripiprazole.",[9],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"Placebo","Placebo add on to aripiprazole",[15],[32],{"name":33,"affiliation":34,"role":35},"Olga B Baltzersen, MD","CNSR, Metal Health Centre Glostrup","PRINCIPAL_INVESTIGATOR",[37],{"name":38,"role":39,"phone":40,"phoneExt":26,"email":41},"Bjorn H Ebdrup, MD, PhD","CONTACT","+4538640840","bebdrup@cnsr.dk",[43],{"facility":44,"status":45,"city":46,"state":47,"zip":48,"country":49,"countryCode":50,"cosmosGeoPoint":51,"geoPoint":56,"contacts":57},"Centre for Neuropsychiatric Schizophrenia Research, CNSR & Centre for Clinical Intervention & Neuropsychiatric Schizophrenia Research, CINS","RECRUITING","Glostrup Municipality","Capitol Region","2600","Denmark","DK",{"type":52,"coordinates":53},"Point",[54,55],12.40377,55.6666,{"lat":55,"lon":54},[58,59],{"name":38,"role":39,"phone":40,"phoneExt":26,"email":41},{"name":33,"role":39,"phone":60,"phoneExt":26,"email":61},"+454028 6171","olga.bengaard.baltzersen@regionh.dk",{"type":63,"investigatorFullName":64,"investigatorTitle":65,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"SPONSOR_INVESTIGATOR","Bjorn H. Ebdrup","Professor, MD PhD, leader of CNSR",[67,69],{"name":68,"class":6},"Lundbeck Foundation",{"name":70,"class":6},"Danish Research Centre for Magnetic Resonance","100423135","phase-1-add-on-memantine-to-dopamine-modulation-to-improve-negative-symptoms-at-first-psychosis-100423135",false,"NCT04789915","Add-on MEmaNtine to Dopamine Modulation to Improve Negative Symptoms at First Psychosis","AMEND - Add-on MEmaNtine to Dopamine Modulation to Improve Negative Symptoms at First Psychosis","AMEND","Inclusion Criteria:\n\n* Patients:\n\n  * Antipsychotic-free(as defined under Exclusion Criteria below), first episode psychosis\n  * Fulfilling the diagnostic criteria of schizophrenia, persistent delusional disorder, acute and transient psychotic disorders, schizoaffective disorder, other non-organic psychotic disorders and unspecified non-organic disorders (ICD-10: F20.x; F22.x; F23.x; F24.x; F25.x; F28; F29); verified by PSE interview.\n  * Age: 18-45 years\n  * Legally competent (In Danish: 'myndige og habile i retslig forstand')\n\nHealthy controls:\n\n* No first-degree relative with known major psychiatric disorder (ICD-10: F1x; F2x; F3x)\n* Age 18-45 years\n* Legally competent (In Danish: 'myndige og habile i retslig forstand')\n\nExclusion Criteria:\n\n* Patients\n\n  * Prior use of antipsychotic medication longer than an episode of two weeks in the previous year and\u002For 6 weeks lifetime, and\u002For antipsychotic treatment within 30 days prior to inclusion.\n  * Treatment with antidepressant medication the last 7 days\n  * Current substance dependence ICD-10 (F1x.2) or substance abuse in any period up to 3 months prior to referral (exception: tobacco\u002Fnicotine, F17.2)\n  * Head injury with more than 5 minutes of unconsciousness, lifetime\n  * Any coercive measure\n  * Metal implanted by operation\n  * Head or neck tattoos\n  * Pacemaker\n  * Pregnancy (assessed by urine HCG)\n  * Female patients: Unwillingness to use safe contraception (Intra Uterine Device\u002FSystem or hormonal contraceptives) during the study period.\n  * Severe physical illness\n  * Allergies to any of the ingredients in the aripiprazole tablets or memantine tablets\n\nHealthy controls:\n\n* Lifetime substance abuse\u002Fdependence ICD-10 (F1x.1\u002FF1x.2) (exception: tobacco\u002Fnicotine, F17.1\u002FF17.2)\n* Lifetime treatment with antidepressants\n* Head injury with more than 5 minutes of unconsciousness\n* Metal implanted by operation\n* Head or neck tattoos\n* Pacemaker\n* Pregnancy (assessed by urine HCG)\n* Severe physical illness",true,"ALL","18 Years","45 Years",{"count":84,"type":85},46,"ESTIMATED","INTERVENTIONAL",[88],"PHASE1","Antipsychotics affects the brain's dopamine system, and the drugs reduce delusions, hallucinations, and disorganized thinking, which are cardinal symptoms of psychotic disorders. However, negative symptoms e.g. anhedonia, avolition, and social withdrawal, as well as cognitive deficits, are not sufficiently treated.\n\nMemantine is used to treat Alzheimer's disease and affects the brain's glutamate system. AMEND is a 12-week, double-blind, placebo-controlled, randomized clinical trial (RCT) testing effects of add-on memantine to initial antipsychotic treatment in never-treated patients with first-episode psychosis.\n\nThe main aim is to reduce negative symptoms. Secondary outcomes are cognition, psychotic symptoms, side effects. Glutamate levels in the brain will be measured before and after 12 weeks using an ultra-high field strength (7 Tesla) magnetic resonance scanner.\n\nAMEND will apply rational drug repurposing to optimize treatment of patients experiencing their first psychotic episode.",[91,92],"Psychosis","Negative Symptoms With Primary Psychotic Disorder",[23,94,95],"Aripiprazole","7 tesla MR","2024-12-04",{"date":98,"type":99},"2024-12-09","ACTUAL",{"date":101,"type":99},"2021-05-26",{"date":103,"type":85},"2026-12-31",{"name":64,"class":6},1]