Clinical trial NCT05956327: Insight Into Hippocampal Neuroplasticity in Schizophrenia by Investigating Molecular Pathways During Physical Training
Official title: Insight Into Hippocampal Neuroplasticity in Schizophrenia by Investigating Molecular Pathways During Physical Training
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Schizophrenia
Neuronal Plasticity
Exercise
Lead sponsor: LMU Klinikum
Sponsor class: OTHER
Collaborators: name: German Research Foundation
First posted: 2023-07-21
Enrollment: 156
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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.


Eligibility 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

Primary outcomes:
measure: Hippocampal volume
timeFrame: 13 weeks
Secondary outcomes:
measure: Cognitive functions
timeFrame: 13 weeks
measure: Executive functions
timeFrame: 13 weeks
measure: Symptoms severity
timeFrame: 13 weeks
measure: Functioning in daily life
timeFrame: 13 weeks
measure: Cardiovascular risk factors
timeFrame: 13 weeks
Other outcomes:
Locations:
city: Munich
country: Germany
facility: LMU Klinikum
state: Bavaria
Study officials:
affiliation: Director of the Department of Psychiatry and Psychotherapy, University Hospital, LMU
name: Peter Falkai, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References: