Clinical Trial

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

Study acronym: LIFETRAIN
Not Yet Recruiting
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Summary
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.
Trial Details
NCT Number NCT07586150
Lead Sponsor Ludwig-Maximilians - University of Munich
Conditions Severe Mental Illness, Depression / Major Depressive Disorder, Bipolar Disorder (BD), Schizophrenia
Enrollment 140 participants
Start Date 2028-10
Primary Completion 2030-07 (estimated)
Study Completion 2030-12 (estimated)
Updated on ClinicalTrials.gov 2026-05-14