New trial combines lifestyle changes and Weight-Loss drug to boost mental health

NCT ID NCT07586150

Not yet recruiting Disease control Sponsor: Ludwig-Maximilians - University of Munich Source: ClinicalTrials.gov ↗

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests whether a personalized program of exercise, diet, sleep support, social activities, and a weight-loss drug (semaglutide) can improve mental functioning in 140 adults with depression, bipolar disorder, or schizophrenia. Participants are randomly assigned to the personalized program or a standard education group. The main goal is to see if mental health scores improve after 3 months.

What this could mean

Our plain-language read of the trial. This is informational only — not medical advice or a prediction.

Active substance: Semaglutide (a once-weekly injection for weight loss and metabolic health), plus personalized exercise, anti-inflammatory diet, sleep intervention, social prescribing, and optional brain stimulation
What this could lead to: If it works, this could point toward a practical, personalized treatment plan that improves mental and physical health for people with severe mental illness.
What could go wrong: This is an early-stage trial with only 140 participants, so results may not apply to everyone. The lifestyle changes require significant effort, and semaglutide can cause side effects like nausea or vomiting.

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Conditions

The condition(s) this trial relates to.

bipolar disorder Depression major depressive disorder psychiatric disorder schizophrenia

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

BIPOLAR DISORDER (BD) DEPRESSION - MAJOR DEPRESSIVE DISORDER SCHIZOPHRENIA SEVERE MENTAL ILLNESS

Contacts and locations

Locations

Central Institute of Mental Health

Mannheim, 68159, Germany
Department of Psychiatry and Psychotherapy, LMU Klinikum

München, 80336, Germany
Medical University of Vienna

Vienna, 1090, Austria
University Medical Center Groningen

Groningen, 9713 GZ, Netherlands
University Medical Center Utrecht

Utrecht, 3584 CX, Netherlands

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