[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100639056":3},{"organization":4,"armGroups":7,"interventions":26,"overallOfficials":32,"centralContacts":63,"locations":69,"responsibleParty":122,"collaborators":32,"id":126,"slug":32,"hasResults":127,"nctId":128,"briefTitle":129,"officialTitle":130,"acronym":131,"eligibilityCriteria":132,"healthyVolunteers":127,"sex":133,"minAge":134,"maxAge":135,"enrollmentInfo":136,"targetDuration":32,"studyType":139,"phases":140,"briefSummary":142,"conditions":143,"keywords":32,"overallStatus":148,"whyStopped":32,"lastUpdateSubmitDate":149,"lastUpdatePostDateStruct":150,"startDateStruct":153,"completionDateStruct":155,"leadSponsor":157,"locationsCount":158},{"fullName":5,"class":6},"Ludwig-Maximilians - University of Munich","OTHER",[8,19],{"label":9,"type":10,"description":11,"interventionNames":12},"Personalized pharmaco-lifestyle intervention","EXPERIMENTAL","Participants receive one or more individualized intervention modules selected according to predefined eligibility criteria, digital guidance, and shared decision-making. Modules may include exercise, anti-inflammatory diet, sleep intervention, social prescribing, semaglutide, and optional closed-loop transcranial alternating current stimulation for participants with prominent depressive symptoms. Weekly guided support is provided through Month 3, followed by self-directed continuation with digital support through Month 6.",[13,14,15,16,17,18],"Drug: Semaglutide (SEMA)","Behavioral: Exercise module","Behavioral: Anti-inflammatory diet module","Behavioral: Sleep intervention module","Behavioral: Social prescribing module","Device: Closed-loop transcranial alternating current stimulation (CL-tACS)",{"label":20,"type":21,"description":22,"interventionNames":23},"Structured lifestyle psychoeducation control","ACTIVE_COMPARATOR","Participants receive structured psychoeducation and counseling on exercise, diet, sleep, and social contact approximately every four weeks through Month 3, followed by self-guided continuation through Month 6. Participants with prominent depressive symptoms may receive sham closed-loop transcranial alternating current stimulation.",[24,25],"Behavioral: Structured lifestyle psychoeducation","Device: Sham CL-tACS",[27,33,38,42,46,50,55,59],{"type":28,"name":29,"description":30,"armGroupLabels":31,"otherNames":32},"DRUG","Semaglutide (SEMA)","Once-weekly subcutaneous semaglutide for eligible participants with overweight or obesity and metabolic risk, titrated according to protocol up to 2.4 mg\u002Fweek as tolerated, followed by tapering after Month 6.",[9],null,{"type":34,"name":35,"description":36,"armGroupLabels":37,"otherNames":32},"BEHAVIORAL","Exercise module","Personalized moderate-intensity exercise intervention with supervised sessions during the structured phase and supported maintenance, targeting at least 150 minutes of moderate physical activity per week.",[9],{"type":34,"name":39,"description":40,"armGroupLabels":41,"otherNames":32},"Anti-inflammatory diet module","Structured anti-inflammatory dietary intervention based on the Brain Anti-Inflammatory Nutrition (BrAIN) diet, supported by coaching, recipes, and digital materials.",[9],{"type":34,"name":43,"description":44,"armGroupLabels":45,"otherNames":32},"Sleep intervention module","Adapted cognitive behavioral therapy for insomnia (SLEEPexpert) including a structured introduction and supported self-management.",[9],{"type":34,"name":47,"description":48,"armGroupLabels":49,"otherNames":32},"Social prescribing module","Structured intervention to increase social participation, community engagement, and behavioral activation.",[9],{"type":51,"name":52,"description":53,"armGroupLabels":54,"otherNames":32},"DEVICE","Closed-loop transcranial alternating current stimulation (CL-tACS)","Optional adjunctive bifrontal closed-loop transcranial alternating current stimulation for participants with prominent depressive symptoms.",[9],{"type":34,"name":56,"description":57,"armGroupLabels":58,"otherNames":32},"Structured lifestyle psychoeducation","Control intervention consisting of psychoeducation and counseling on lifestyle domains with self-guided continuation.",[20],{"type":51,"name":60,"description":61,"armGroupLabels":62,"otherNames":32},"Sham CL-tACS","Sham closed-loop transcranial alternating current stimulation in the control arm for eligible participants with prominent depressive symptoms.",[20],[64],{"name":65,"role":66,"phone":67,"phoneExt":32,"email":68},"Peter Falkai, MD","CONTACT","+49 89 4400 - 55501","peter.falkai@med.uni-muenchen.de",[70,82,93,102,113],{"facility":71,"status":32,"city":72,"state":32,"zip":73,"country":74,"countryCode":75,"cosmosGeoPoint":76,"geoPoint":81,"contacts":32},"Medical University of Vienna","Vienna","1090","Austria","AT",{"type":77,"coordinates":78},"Point",[79,80],16.37208,48.20849,{"lat":80,"lon":79},{"facility":83,"status":32,"city":84,"state":32,"zip":85,"country":86,"countryCode":87,"cosmosGeoPoint":88,"geoPoint":92,"contacts":32},"Central Institute of Mental Health","Mannheim","68159","Germany","DE",{"type":77,"coordinates":89},[90,91],8.46694,49.4891,{"lat":91,"lon":90},{"facility":94,"status":32,"city":95,"state":32,"zip":96,"country":86,"countryCode":87,"cosmosGeoPoint":97,"geoPoint":101,"contacts":32},"Department of Psychiatry and Psychotherapy, LMU Klinikum","München","80336",{"type":77,"coordinates":98},[99,100],13.31243,51.60698,{"lat":100,"lon":99},{"facility":103,"status":32,"city":104,"state":32,"zip":105,"country":106,"countryCode":107,"cosmosGeoPoint":108,"geoPoint":112,"contacts":32},"University Medical Center Groningen","Groningen","9713 GZ","Netherlands","NL",{"type":77,"coordinates":109},[110,111],6.56667,53.21917,{"lat":111,"lon":110},{"facility":114,"status":32,"city":115,"state":32,"zip":116,"country":106,"countryCode":107,"cosmosGeoPoint":117,"geoPoint":121,"contacts":32},"University Medical Center Utrecht","Utrecht","3584 CX",{"type":77,"coordinates":118},[119,120],5.12222,52.09083,{"lat":120,"lon":119},{"type":123,"investigatorFullName":124,"investigatorTitle":125,"investigatorAffiliation":5,"oldNameTitle":32,"oldOrganization":32},"PRINCIPAL_INVESTIGATOR","Isabel Maurus","Senior Consultant, Department of Psychiatry and Psychotherapy, LMU University Hospital","100639056",false,"NCT07586150","Personalized Pharmaco-Lifestyle Interventions for Severe Mental Illnesses (LIFETRAIN)","Personalised Pharmaco-Lifestyle Interventions for Severe Mental Illnesses Enhanced by Digital Health and Immersive Technologies","LIFETRAIN","Inclusion Criteria:\n\n* Age 18 to 65 years\n* Able and willing to provide written informed consent\n* Diagnosis of schizophrenia, bipolar disorder, or major depressive disorder according to DSM-5-TR, confirmed by M.I.N.I.\n* Female participants of childbearing potential must agree to use an effective method of contraception\n* Stable psychopathology defined as BPRS less than or equal to 41, MADRS less than or equal to 34, and YMRS less than or equal to 25, with stable psychopharmacological treatment for at least 2 weeks\n* Reduced functioning at screening defined as SF-36 score less than or equal to 40\n* If using benzodiazepines, dose less than or equal to 2 mg lorazepam equivalent per day\n* Stable somatic condition for at least 4 weeks\n* For semaglutide treatment: overweight with BMI at least 27 and less than 30 kg\u002Fm² plus at least one weight-related risk condition, or obesity with BMI at least 30 kg\u002Fm²\n* For optional adaptive neurostimulation: MADRS score at least 19\n* Expected ability to comply with study procedures in the investigator's judgment\n\nExclusion Criteria:\n\n* Unable to provide informed consent\n* Current or past neurological disorder or structural brain pathology that may affect study procedures\n* Known intolerance or hypersensitivity to semaglutide\n* Pregnancy or lactation\n* Serious suicidal risk\n* Substance dependence within the last 3 months\n* BMI less than 18.5 kg\u002Fm²\n* eGFR less than 30 mL\u002Fmin\u002F1.73 m²\n* Type 1 diabetes, diabetic ketoacidosis, diabetic retinopathy, or poorly controlled diabetes with recurrent hypoglycemic episodes\n* Pancreatitis, history of pancreatitis, or pancreatic cancer\n* Multiple endocrine neoplasia type 2 or personal\u002Ffamily history of medullary thyroid cancer\n* Pre-existing significant gastrointestinal conditions such as inflammatory bowel disease or gastroparesis\n* Need for acute surgery\n* Other medical condition that may affect study procedures or participant safety\n* For optional adaptive neurostimulation: nonremovable metal in or around the head, known increased intracranial pressure due to infarcts or trauma, professional metal work or prior ocular metal injury, history of rTMS or ECT, or current (es)ketamine treatment","ALL","18 Years","65 Years",{"count":137,"type":138},140,"ESTIMATED","INTERVENTIONAL",[141],"NA","This randomized, rater-blind, multicenter clinical trial will evaluate whether a personalized pharmaco-lifestyle intervention improves mental functioning in adults with severe mental illness, including schizophrenia, bipolar disorder, or major depressive disorder. Participants will be randomized to either a modular individualized intervention program or a structured psychoeducation control condition. The individualized intervention may include physical exercise, an anti-inflammatory diet, sleep intervention, social prescribing, semaglutide for eligible participants with overweight or obesity, and optional closed-loop transcranial alternating current stimulation for participants with prominent depressive symptoms. The primary outcome is change in the SF-36 Mental Component Summary score from baseline to Month 3.",[144,145,146,147],"Severe Mental Illness","Depression \u002F Major Depressive Disorder","Bipolar Disorder (BD)","Schizophrenia","NOT_YET_RECRUITING","2026-05-07",{"date":151,"type":152},"2026-05-14","ACTUAL",{"date":154,"type":138},"2028-10",{"date":156,"type":138},"2030-12",{"name":5,"class":6},5]