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

What Was Tested

This registered not phased trial tested Semaglutide.

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.

It had two arms (groups): one (experimental) and Structured lifestyle psychoeducation control (active comparator).

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.

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.

The registry classes the interventions as behavioral, device and drug.

Who Took Part

Enrollment: 140 planned participants were the target.

It was open to people of any sex aged from 18 years up to 65 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: 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. 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.

The full record lists 11 inclusion and 15 exclusion criteria; among the exclusions: 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.

How the Study Was Run

It was run as a randomized, parallel-group and single-blind study.

The participants were allocated by chance, so the Semaglutide group and the comparison group should start out alike.

The Semaglutide group and the comparison group ran side by side rather than switching.

In this single-blind Semaglutide study one party knew the assignments and the other did not.

Those kept unaware of assignments: outcomes assessor.

It started in 2028-10 with completion listed for 2030-07.

It ran at 5 sites in Germany (2), Netherlands (2) and Austria (1).

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Change in Short Form 36 Health Survey (SF-36) Mental Component Summary (MCS) score (time frame: Baseline to Month 3).

It also tracked 21 secondary outcomes, for example Change in Short Form 36 Health Survey (SF-36) Mental Component Summary score (MCS) at Month 6, Change in Short Form 36 Health Survey (SF-36) Physical Component Summary (PCS) score, Change in Short Form 36 Health Survey (SF-36) total score, Change in MATRICS Consensus Cognitive Battery, Change in Insomnia Severity Index (ISI) and Change in UCLA Loneliness Scale score.

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Semaglutide in 140 people.

Its status is not yet recruiting; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Semaglutide compound page, all human trials.