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

NCT ID NCT07586150

Disease control Sponsor: Ludwig-Maximilians - University of Munich Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 140 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Oct 2028

An estimate. Start dates often move.

Expected to finish

Dec 2030

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 65 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 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 Criteria: * 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

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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

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    5 sites in 3 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

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

More trials for these conditions

Other studies related to the condition(s) this trial covers.