Personalized Pharmaco-Lifestyle Interventions for Severe Mental Illnesses (LIFETRAIN)

Starting soon · Not applicable · Has a placebo group

Conditions studied: Severe Mental Illness, Depression / Major Depressive Disorder, Bipolar Disorder (BD), Schizophrenia

In brief

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.

Key facts

Study ID: NCT07586150
Run by: Ludwig-Maximilians - University of Munich
People needed: 140
Starts: 2028-10-01
Expected to finish: 2030-12-01
Last updated by the study team: 2026-05-14

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

Unable to provide informed consent
Current or past neurological disorder or structural brain pathology that may affect study procedures
Known intolerance or hypersensitivity to semaglutide
Pregnancy or lactation
Serious suicidal risk
Substance dependence within the last 3 months
BMI less than 18.5 kg/m²
eGFR less than 30 mL/min/1.73 m²
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
Need for acute surgery
Other medical condition that may affect study procedures or participant safety
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

Where it is running

Medical University of Vienna — Vienna, Austria
Central Institute of Mental Health — Mannheim, Germany
Department of Psychiatry and Psychotherapy, LMU Klinikum — München, Germany
University Medical Center Groningen — Groningen, Netherlands
University Medical Center Utrecht — Utrecht, Netherlands

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.