[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Bjorn H. Ebdrup\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":110},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,50,83],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":15,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":23,"conditions":24,"keywords":28,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":38,"lastUpdatePostDateStruct":39,"startDateStruct":42,"completionDateStruct":44,"leadSponsor":46,"locationsCount":49},"100573240","validation-and-impact-of-cardiorespiratory-fitness-in-severe-mental-illness---the-heart-in-mind-project-100573240",false,"NCT06743711","Validation and Impact of Cardiorespiratory Fitness in Severe Mental Illness - the Heart in Mind Project","Inclusion Criteria:\n\n* 18-45 years\n* Diagnosis within schizophrenia spectrum or affective disorders (i.e. F2.x or F3.x according to ICD-10 classification)\n* current antipsychotic treatment for more than one month on a regular daily dose\n* Able to give informed consent.\n\nExclusion Criteria:\n\n* Clinical or laboratory evidence of uncompensated medical disease\n* Unstable psychiatric disorder\n* Acute suicidal risk\n* Planned hospitalization within the study period.",true,"ALL","18 Years","45 Years",{"count":20,"type":21},75,"ESTIMATED","OBSERVATIONAL","This project aims to evaluate feasibility, validity and clinically applicability to systematically measure fitness in patients with severe mental illness.\n\nThe research project is a validation study using a cross-sectional design. The project will include 50 people with severe mental illness and 25 healthy controls without present or previous mental illness. The protocol includes a baseline visit where three different ways of measure fitness will be carried out, and a 14-day period of physical activity monitoring.",[25,26,27],"Severe Mental Illness","Schizophrenia Spectrum &Amp; Other Psychotic Disorders","Bipolar Affective Disorder",[29,30,31,32,33,34,35,36],"cardiorespiratory fitness","severe mental illness","cardiovascular disease","validation","physical activity","cardiopulmonary exercise test","non-exercise vo2max estimation","vo2max","RECRUITING","2026-04-28",{"date":40,"type":41},"2026-05-04","ACTUAL",{"date":43,"type":41},"2025-01-01",{"date":45,"type":21},"2026-06-30",{"name":47,"class":48},"Bjorn H. Ebdrup","OTHER",1,{"id":51,"slug":52,"hasResults":11,"nctId":53,"briefTitle":54,"officialTitle":54,"acronym":4,"eligibilityCriteria":55,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":56,"targetDuration":4,"studyType":58,"phases":59,"briefSummary":61,"conditions":62,"keywords":68,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":75,"lastUpdatePostDateStruct":76,"startDateStruct":78,"completionDateStruct":80,"leadSponsor":82,"locationsCount":49},"100564076","effectiveness-of-a-pragmatic-metabolic-care-clinic-for-patients-with-severe-mental-illness---the-meta-care-clinic-100564076","NCT06624462","Effectiveness of a Pragmatic, Metabolic Care Clinic for Patients With Severe Mental Illness - The Meta Care Clinic","Inclusion Criteria:\n\n* Patients with schizophrenia spectrum disorders (International classification of diseases; ICD-10: DF2x) or bipolar disorder (ICD-10: DF30.x or DF31.x)\n* Medical treatment with antipsychotics\n* Age 18-45 years\n* Legally competent\n* Able to give informed consent\n\nand either:\n\n\\- Body mass index (BMI) ≥30 kg\u002Fm2.\n\nOr\n\n* BMI ≥27 kg\u002Fm2 and at least one of the following:\n* Hypertension defined as treatment with ≥1 antihypertensive drug or out-of-office \u002F 24-hour, non-invasive ambulatory blood pressure ≥140\u002F90 mmHg within the previous 6 months\n* Dyslipidaemia defined as treatment with ≥1 lipid-lowering drug or elevated low-density lipoprotein (LDL) cholesterol (≥3.0 mmol\u002Fl), elevated triglycerides (≥1.7 mmol\u002Fl) or low high-density lipoprotein cholesterol (≥1.2 mmol\u002Fl in women and ≥1.0 mmol\u002Fl in men) within the previous 6 months\n* Sleep apnoea (ICD-10 DG473).\n* Prediabetes or diabetes defined as HbA1c ≥42 mmol\u002Fmol or impaired fasting glucose as defined by the International Diabetes Federation within the previous 6 months.\n\nOr\n\n\\- a history of rapid weight gain during antipsychotic therapy defined as increases of either ≥5% body weight or ≥5 cm waist circumference since initiation of antipsychotic therapy.\n\nExclusion Criteria:\n\n* Clinical or laboratory evidence of comorbid medical disease not compatible with participation as judged by the research team.\n* Unstable psychiatric disorder as judged by the research team.\n* Severe current drug or alcohol misuse as judged by the research team.\n* Acute suicidal risk.",{"count":57,"type":21},84,"INTERVENTIONAL",[60],"NA","This study will examine the effectiveness of a Pragmatic, Metabolic Care Clinic for Patients With Severe Mental Illness",[63,64,65,66,67],"Severe Mental Disorder","Metabolic Complication","Side-Effect;Medication","Schizophrenia Spectrum and Other Psychotic Disorders","Bipolar Disorder",[69,70,71,72,73,74],"Severe mental illness","Overweight and obesity","Antipsychotic medication","Dysmetabolism","Schizophrenia Spectrum Disorders","Bipolar disorder","2026-01-06",{"date":77,"type":41},"2026-01-08",{"date":79,"type":41},"2023-10-10",{"date":81,"type":21},"2026-12-31",{"name":47,"class":48},{"id":84,"slug":85,"hasResults":11,"nctId":86,"briefTitle":87,"officialTitle":88,"acronym":89,"eligibilityCriteria":90,"healthyVolunteers":15,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":91,"targetDuration":4,"studyType":58,"phases":93,"briefSummary":95,"conditions":96,"keywords":99,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":103,"lastUpdatePostDateStruct":104,"startDateStruct":106,"completionDateStruct":108,"leadSponsor":109,"locationsCount":49},"100423135","phase-1-add-on-memantine-to-dopamine-modulation-to-improve-negative-symptoms-at-first-psychosis-100423135","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",{"count":92,"type":21},46,[94],"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.",[97,98],"Psychosis","Negative Symptoms With Primary Psychotic Disorder",[100,101,102],"Memantine","Aripiprazole","7 tesla MR","2024-12-04",{"date":105,"type":41},"2024-12-09",{"date":107,"type":41},"2021-05-26",{"date":81,"type":21},{"name":47,"class":48},""]