Personalized medicine and lifestyle program for severe mental illness
Tests tailored lifestyle and drug care in adults with schizophrenia, bipolar disorder or depression.
Plain-language title generated from the registry record
Registry title: Personalized Pharmaco-Lifestyle Interventions for Severe Mental Illnesses (LIFETRAIN)
Key facts
- Where
- Mannheim and München, GermanySee the 2 sites
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 65 years old?
Source: NCT07586150, who can take part
Where in Germany
- Central Institute of Mental HealthMannheim, GermanyNo longer taking part
- Department of Psychiatry and Psychotherapy, LMU KlinikumMünchen, GermanyNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Ludwig-Maximilians - University of Munich
- Trial code
- NCT07586150
- Record updated
- 14 May 2026
- Original description
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.Read full original descriptionShow less
Personalised Pharmaco-Lifestyle Interventions for Severe Mental Illnesses Enhanced by Digital Health and Immersive Technologies
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.
Inclusion: 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.
Exclusion: 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; 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; eGFR less than 30 mL/min/1.73 m²; 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.