Insight Into Hippocampal Neuroplasticity in Schizophrenia by Investigating Molecular Pathways During Physical Training

Schizophrenia Clinical Trial

— BrainTrain  

Official title:

Insight Into Hippocampal Neuroplasticity in Schizophrenia by Investigating Molecular Pathways During Physical Training

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05956327
• Other study ID #: BI 576/9-1, FA 241/21-1
• Status: Recruiting
• Phase: N/A
• Start date: September 29, 2023
• Est. completion date: September 2026

Study information

• Verified date: November 2023
• Source: LMU Klinikum
• Contact: Isabel Maurus, Dr.
• Phone: +49 89 4400 55537
• Email: Isabel.Maurus[@]med.uni-muenchen.de
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Aerobic endurance training has shown positive effects on symptoms, cognition, daily functioning, and the structure of the hippocampus in patients with schizophrenia. The study investigates genetic and epigenetic influences on neuroplastic changes following three months of endurance training. A control group performs flexibility, strength, and balance training. The main objective is to examine the association between a genetic risk score for schizophrenia and volume increase in the CA4/DG region of the hippocampus. Additional goals include examining changes in synapses, brain structure, function, and metabolism, as well as clinical symptoms and cognitive performance.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 156
• Est. completion date: September 2026
• Est. primary completion date: September 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Exercise
• Neuronal Plasticity
• Schizophrenia

Intervention

Procedure:
• Aerobic Endurance Training
Aerobic endurance training on a bicycle ergometer (week 1 to 6: three units per week á 40 minutes, week 7 to 12: three units á 45 minutes, in groups of up to three patients over 13 weeks)
• Flexibility, strengthening and balance training
Flexibility, strengthening and balance training (exercises from the areas of stretching, strength, balance and relaxation, 3x40 min from week 1-2, 3x45 min from week 3-4 and 3x50 min from week 5-13, in groups of up to three patients over 13 weeks)

Locations

Country	Name	City	State
Germany	LMU Klinikum	Munich	Bavaria

Sponsors (2)

Lead Sponsor	Collaborator
LMU Klinikum	German Research Foundation

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hippocampal volume	Change in hippocampal subregion cornu ammonis (CA) 4 volume (?CA4/DG) and its correlation with polygenetic risk factor (PRS)	13 weeks
Secondary	Cognitive functions	verbal memory, working memory, motor speed, verbal fluency, attention and speed of information processing assessed by BACS	13 weeks
Secondary	Executive functions	visual attention and task switching (TMT-A, B), episodic memory with the What-Where-When Test and visuo-spatial short- and long-term memory with the Brief Visuospatial Memory Test-Revised (BVMT-R)	13 weeks
Secondary	Symptoms severity	change over study duration assessed by PANSS, BNSS, CDSS	13 weeks
Secondary	Functioning in daily life	Assessed by SOFAS, GAF, FROGS	13 weeks
Secondary	Cardiovascular risk factors	Aerobic fitness levels (W/kg), body weight, waist circumference, body fat, lipid panel, HbA1c, physical activity as assessed with the IPAQ will be evaluated.	13 weeks