Exploring how exercise affects brain changes in schizophrenia
Insight Into Hippocampal Neuroplasticity in Schizophrenia by Investigating Molecular Pathways During Physical Training
This study tests whether three months of aerobic exercise can help improve brain changes and symptoms in people with schizophrenia compared to those doing other types of exercises.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 156 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | LMU Klinikum Academic / other |
| Locations | 1 site (Munich, Bavaria) |
| Trial ID | NCT05956327 on ClinicalTrials.gov |
What this trial studies
This study investigates the effects of aerobic endurance training on patients with schizophrenia, focusing on how physical exercise influences neuroplasticity in the hippocampus. Participants will engage in three months of endurance training, while a control group will perform flexibility, strength, and balance exercises. The research aims to understand the relationship between genetic risk factors for schizophrenia and changes in brain structure, specifically in the CA4/DG region of the hippocampus. Additionally, it will assess improvements in clinical symptoms and cognitive performance resulting from the exercise intervention.
Who should consider this trial
Good fit: Ideal candidates for this study are individuals diagnosed with schizophrenia who meet specific clinical criteria and are stable on their antipsychotic medication.
Not a fit: Patients with severe schizophrenia symptoms or those not on stable medication regimens may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to new therapeutic strategies that enhance cognitive and functional outcomes for patients with schizophrenia through physical exercise.
How similar studies have performed: Previous studies have shown positive effects of exercise on cognitive and functional outcomes in schizophrenia, suggesting that this approach may be promising.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Written informed consent for voluntary study participation. * Patients with schizophrenia: diagnosis of schizophrenic psychosis according to ICD10 and DSM V, * Positive And Negative Syndrome Scale (PANSS) total score ≤ 75 before the start of the intervention * Reliable contraception in women of childbearing age * Patients must have been treated with individualized medication according to valid treatment guidelines. All antipsychotic substances are allowed, also as depot medication. Treatment with one as well as with two antipsychotic substances is possible. The additional administration of low- and medium-potency antipsychotic substances as on-demand medication for the treatment of agitation and sleep disorders is possible, provided that the daily dosage of 150 CPZ units is not exceeded. The active substance and dose of the individualized antipsychotic medication used to achieve the inclusion criterion of psychopathological symptom remission must be constant for at least 2 weeks before inclusion in the study. Exclusion Criteria: * Lack of reliability and sanity (examined by an independent psychiatrist) * Positive urine drug screen for illicit drugs (except benzodiazepines) * Acute suicide risk * Other relevant psychiatric axis-I disorders according to the diagnostic testing procedure (Mini International Neuropsychiatric Interview, MINI) * Other relevant neurological or other disorders * Pregnancy or lactation
Where this trial is running
Munich, Bavaria
- LMU Klinikum — Munich, Bavaria, Germany (Recruiting)
Study contacts
- Principal investigator: Peter Falkai, Prof. Dr. — Director of the Department of Psychiatry and Psychotherapy, University Hospital, LMU
- Study coordinator: Isabel Maurus, Dr.
- Email: Isabel.Maurus@med.uni-muenchen.de
- Phone: +49 89 4400 55537
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.