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Severe Mental IllnessLIFETRAINNCT07586150

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

A study testing Semaglutide (SEMA), Exercise module and Anti-inflammatory diet module in people with Severe Mental Illness and Depression / Major Depressive Disorder, run by Ludwig-Maximilians - University of Munich at 5 sites in 3 countries.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 to 65 years
What is being tested?
Semaglutide (SEMA), Exercise module and Anti-inflammatory diet module
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
140 participants
Where
5 sitesin 3 countries
Study dates
Oct 2028to Dec 2030
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to 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.
  • 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
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  • 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 join

  • 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
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  • 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

Trial locations and contacts

5 sites in 3 countries. Contact the study team or a site near you to ask about taking part.

Peter Falkai, MD contact

+49 89 4400 - 55501

peter.falkai@med.uni-muenchen.de

5 sites in 3 countries

Germany2 sites

  • Central Institute of Mental Health

    Mannheim, 68159

  • Department of Psychiatry and Psychotherapy, LMU Klinikum

    München, 80336

Other trials in Germany

Netherlands2 sites

  • University Medical Center Groningen

    Groningen, 9713 GZ

  • University Medical Center Utrecht

    Utrecht, 3584 CX

Other trials in Netherlands

Austria1 site

  • Medical University of Vienna

    Vienna, 1090

Other trials in Austria

About this study

Official title: Personalised Pharmaco-Lifestyle Interventions for Severe Mental Illnesses Enhanced by Digital Health and Immersive Technologies

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.

Being tested
Semaglutide (SEMA), Exercise module, Anti-inflammatory diet module, Sleep intervention module, Social prescribing module
Medical subject headings
Mental Disorders, Depression, Depressive Disorder, Major, Bipolar Disorder, Schizophrenia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Semaglutide (SEMA)Drug

    Once-weekly subcutaneous semaglutide for eligible participants with overweight or obesity and metabolic risk, titrated according to protocol up to 2.4 mg/week as tolerated, followed by tapering after Month 6.

  • Exercise moduleBehavioural

    Personalized moderate-intensity exercise intervention with supervised sessions during the structured phase and supported maintenance, targeting at least 150 minutes of moderate physical activity per week.

  • Anti-inflammatory diet moduleBehavioural

    Structured anti-inflammatory dietary intervention based on the Brain Anti-Inflammatory Nutrition (BrAIN) diet, supported by coaching, recipes, and digital materials.

  • Sleep intervention moduleBehavioural

    Adapted cognitive behavioral therapy for insomnia (SLEEPexpert) including a structured introduction and supported self-management.

  • Social prescribing moduleBehavioural

    Structured intervention to increase social participation, community engagement, and behavioral activation.

  • Closed-loop transcranial alternating current stimulation (CL-tACS)Device

    Optional adjunctive bifrontal closed-loop transcranial alternating current stimulation for participants with prominent depressive symptoms.

  • Structured lifestyle psychoeducationBehavioural

    Control intervention consisting of psychoeducation and counseling on lifestyle domains with self-guided continuation.

  • Sham CL-tACSDevice

    Sham closed-loop transcranial alternating current stimulation in the control arm for eligible participants with prominent depressive symptoms.

Study groups in NCT07586150
Study groupRoleWhat they receive
Personalized pharmaco-lifestyle interventionExperimentalParticipants 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.
Receives: Drug: Semaglutide (SEMA); Behavioral: Exercise module; Behavioral: Anti-inflammatory diet module; Behavioral: Sleep intervention module; Behavioral: Social prescribing module; Device: Closed-loop transcranial alternating current stimulation (CL-tACS)
Structured lifestyle psychoeducation controlActive comparatorParticipants 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.
Receives: Behavioral: Structured lifestyle psychoeducation; Device: Sham CL-tACS

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in Short Form 36 Health Survey (SF-36) Mental Component Summary (MCS) score

    Change from baseline in the SF-36 Mental Component Summary score.

    Measured: Baseline to Month 3

Secondary outcomes (21)

  1. Change in Short Form 36 Health Survey (SF-36) Mental Component Summary score (MCS) at Month 6

    Measured: Baseline to Month 6

  2. Change in Short Form 36 Health Survey (SF-36) Physical Component Summary (PCS) score

    Measured: Baseline to Month 3 and Month 6

  3. Change in Short Form 36 Health Survey (SF-36) total score

    Measured: Baseline to Month 3 and Month 6

  4. Change in MATRICS Consensus Cognitive Battery

    Measured: Baseline to Month 3 and Month 6

  5. Change in Insomnia Severity Index (ISI)

    Measured: Baseline to Month 3 and Month 6

  6. Change in UCLA Loneliness Scale score

    Measured: Baseline to Month 3 and Month 6

  7. Change in International Physical Activity Questionnaire

    Measured: Baseline to Month 3 and Month 6

  8. Change in EQ-5D-3L score

    Measured: Baseline to Month 3 and Month 6

  9. Incidence of adverse events and serious adverse events

    Measured: Baseline through day 240-243

  10. Change in Brief Psychiatric Rating Scale (BPRS) psychotic symptoms

    Measured: Baseline to Month 3 and Month 6

  11. Change in Montgomery-Åsberg Depression Rating Scale (MADRS)

    Measured: Baseline to Month 3 and Month 6

  12. Change in Young Mania Rating Scale (YMRS)

    Measured: Baseline to Month 3 and Month 6

  13. Change in Pittsburgh Sleep Quality Index (PSQI) scores

    Measured: Baseline to Month 3 and Month 6

  14. Change in step aerobic test performance

    Measured: Baseline to Month 3 and Month 6

  15. Change in grip strength

    Measured: Baseline to Month 3 and Month 6

  16. Change in body weight

    Measured: Baseline to Month 3 and Month 6

  17. Change in body mass index (BMI)

    Weight and height will be combined to report BMI in kg/m^2

    Measured: Baseline to Month 3 and Month 6

  18. Change in waist-to-hip ratio

    Measured: Baseline to Month 3 and Month 6

  19. Chage in blood pressure

    Measured: Baseline to Month 3 and Month 6

  20. Change in lean mass

    Measured: Baseline to Month 3 and Month 6

  21. Change in fat mass

    Measured: Baseline to Month 3 and Month 6

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 May 2026
  2. Study startOct 2028 (estimated)
  3. Primary completionJul 2030 (estimated)
  4. Study completionDec 2030 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Participants are randomized in a parallel 1:1 design to either an individualized personalized intervention arm or an active control arm. Within the individualized intervention arm, participants may receive one or more intervention modules according to predefined eligibility criteria, digital decision support, and shared decision-making with the treating clinician.
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
140 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07586150
Sponsor's protocol ID
LIFETRAIN
Other IDs
U1111-1340-3272
Acronym
LIFETRAIN
Status last verified
May 2026
First submitted
9 Apr 2026
Last updated
14 May 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A study testing Semaglutide (SEMA), Exercise module and Anti-inflammatory diet module in people with Severe Mental Illness and Depression / Major Depressive Disorder, run by Ludwig-Maximilians - University of Munich at 5 sites in 3 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 14 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in Germany, Netherlands, Austria. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Peter Falkai, MD (+49 89 4400 - 55501, peter.falkai@med.uni-muenchen.de), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Short Form 36 Health Survey (SF-36) Mental Component Summary (MCS) score (time frame: Baseline to Month 3). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07586150.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 May 2026.

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