Not yet taking people in NetherlandsNo phase

Personalized medicine and lifestyle program for severe mental illness

Tests tailored lifestyle and drug care in adults with schizophrenia, bipolar disorder or depression.

Key facts

Who runs it: Ludwig-Maximilians - University of Munich
Where: Groningen and Utrecht, NetherlandsSee the 2 sitesAlso in 2 other countries, 3 sites
Trial code: NCT07586150
U1111-1340-3272
Registry title: Personalized Pharmaco-Lifestyle Interventions for Severe Mental Illnesses (LIFETRAIN)
Status: Not yet recruiting
People taking part: 140 people, planned
Starts: Oct 2028
Expected to end: Dec 2030
Type of study: Interventional, 2 groupsOne group gets an existing treatment, for comparison.
Treatments tested: Semaglutide (SEMA)
Exercise module
Anti-inflammatory diet module
Sleep intervention module
Social prescribing module
Closed-loop transcranial alternating current stimulation (CL-tACS)
Structured lifestyle psychoeducation
Sham CL-tACS
Record updated: 14 May 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults aged 18 to 65 with schizophrenia, bipolar disorder or major depressive disorder whose mental state is stable but whose daily functioning is reduced.

Age: 18 to 65 years
Sex: All sexes can join.
Disease stage: Schizophrenia, bipolar disorder or major depressive disorder, confirmed by a structured interview (M.I.N.I.). Symptoms must be stable: BPRS 41 or less, MADRS 34 or less, YMRS 25 or less. Reduced functioning: SF-36 score of 40 or less.
Earlier treatment: Psychiatric medicines must have been stable for at least 2 weeks. Benzodiazepines, if used, must be 2 mg lorazepam equivalent per day or less. Physical health must have been stable for at least 4 weeks.
Biomarker or test result: For the semaglutide part: BMI 30 or more, or BMI 27 to under 30 with at least one weight-related risk condition. For the optional brain stimulation part: MADRS score of 19 or more.

Main reasons for not taking part

Serious suicide risk
Substance dependence within the last 3 months
Pregnancy or breastfeeding
Brain or nervous system disorder, or structural brain problem
Type 1 diabetes, pancreatitis, or thyroid cancer risk (MEN2 or medullary thyroid cancer history)

The registry criteria, word for word

Show all 26 criteriaShow less

Who can take part

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

Who cannot take part

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

Check if you might fit

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

Are you between 18 and 65 years old?

Where in Netherlands

Also in 2 other countries, 3 sites

University Medical Center GroningenGroningen, NetherlandsContact: Peter Falkai, MDNo longer taking part
University Medical Center UtrechtUtrecht, NetherlandsContact: Peter Falkai, MDNo longer taking part

About the trial

What the trial wants to find out

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.

The 2 groups in the trial

Personalized pharmaco-lifestyle interventionTreatment being tested
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.
Treatment: Semaglutide (SEMA), Exercise module, Anti-inflammatory diet module, Sleep intervention module, Social prescribing module, and Closed-loop transcranial alternating current stimulation (CL-tACS)
Structured lifestyle psychoeducation controlExisting treatment, for comparison
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.
Treatment: Structured lifestyle psychoeducation and Sham CL-tACS