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

ConditionsSevere Mental IllnessDepression / Major Depressive DisorderBipolar Disorder (BD)Schizophrenia
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorLudwig-Maximilians - University of Munich

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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 module

    Behavioral

    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 module

    Behavioral

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

  • Sleep intervention module

    Behavioral

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

  • Social prescribing module

    Behavioral

    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 psychoeducation

    Behavioral

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

  • Sham CL-tACS

    Device

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

Treatment groups

140 Participants
are divided into 2 treatment groups
Group A: Personalized pharmaco-lifestyle interventionExperimental treatment 6 interventions
Group B: Structured lifestyle psychoeducation controlActive comparator 2 interventions

Trial outcomes

Primary outcomes

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.

Time frame
Baseline to Month 3

Secondary outcomes

1

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

Time frame
Baseline to Month 6
2

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

Time frame
Baseline to Month 3 and Month 6
3

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

Time frame
Baseline to Month 3 and Month 6
4

Change in MATRICS Consensus Cognitive Battery

Time frame
Baseline to Month 3 and Month 6

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Ludwig-Maximilians - University of Munich

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: