NCT07586150Not yet recruiting
Personalized Pharmaco-Lifestyle Interventions for Severe Mental Illnesses (LIFETRAIN)
Personalised Pharmaco-Lifestyle Interventions for Severe Mental Illnesses Enhanced by Digital Health and Immersive Technologies
Source: ClinicalTrials.gov · Last updated 14 May 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 140 (estimated)
- First submitted
- 9 Apr 2026
- Start date
- 1 Oct 2028
- Primary completion date
- 31 Jul 2030
- Lead sponsor
- Ludwig-Maximilians - University of Munich
- Diseases
- Schizophrenia, Depression, Bipolar disorder
- NCT number
- NCT07586150
What you commit to
- Study type: Interventional
- Planned participants: 140
- From 1 Oct 2028 to the primary completion date, 31 Jul 2030
- 5 sites in 3 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Need for acute surgery
- 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
Other illness
- Current or past neurological disorder or structural brain pathology that may affect study procedures
- Known intolerance or hypersensitivity to semaglutide
- Type 1 diabetes, diabetic ketoacidosis, diabetic retinopathy, or poorly controlled diabetes with recurrent hypoglycemic episodes
- Pancreatitis, history of pancreatitis, or pancreatic cancer
- Multiple endocrine neoplasia type 2 or personal/family history of medullary thyroid cancer
- Pre-existing significant gastrointestinal conditions such as inflammatory bowel disease or gastroparesis
- Other medical condition that may affect study procedures or participant safety
Lab values
- eGFR less than 30 mL/min/1.73 m²
Other
- Unable to provide informed consent
- Pregnancy or lactation
- Serious suicidal risk
- Substance dependence within the last 3 months
- BMI less than 18.5 kg/m²
Who the study is looking for
- Age 18 to 65 years
- Able and willing to provide written informed consent
- Diagnosis of schizophrenia, bipolar disorder, or major depressive disorder according to DSM-5-TR, confirmed by M.I.N.I.
- Female participants of childbearing potential must agree to use an effective method of contraception
- 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
- Reduced functioning at screening defined as SF-36 score less than or equal to 40
- If using benzodiazepines, dose less than or equal to 2 mg lorazepam equivalent per day
- Stable somatic condition for at least 4 weeks
- For semaglutide treatment: overweight with BMI at least 27 and less than 30 kg/m² plus at least one weight-related risk condition, or obesity with BMI at least 30 kg/m²
- For optional adaptive neurostimulation: MADRS score at least 19
- Expected ability to comply with study procedures in the investigator's judgment
Age in the registry: 18 years to 65 years · Sex: All · Does not accept healthy volunteers
Sites (5)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Medical University of Vienna Coordinator of this site? Confirm its status | Vienna | Austria | Unknown status |
| Central Institute of Mental Health Coordinator of this site? Confirm its status | Mannheim | Germany | Unknown status |
| Department of Psychiatry and Psychotherapy, LMU Klinikum Coordinator of this site? Confirm its status | München | Germany | Unknown status |
| University Medical Center Groningen Coordinator of this site? Confirm its status | Groningen | Netherlands | Unknown status |
| University Medical Center Utrecht Coordinator of this site? Confirm its status | Utrecht | Netherlands | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.