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Insight into hippocampal neuroplasticity in schizophrenia by investigating molecular pathways during physical training

Not Applicable
Recruiting
Conditions
F20
Schizophrenia
Registration Number
DRKS00032187
Lead Sponsor
Klinik für Psychiatrie und Psychotherapie, LMU Klinikum
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Recruiting
Sex
All
Target Recruitment
156
Inclusion Criteria

Written informed consent for voluntary study participation. Patients with schizophrenia: diagnosis of schizophrenic psychosis according to ICD10 and DSM V, age between 18 and 65 years, male or female, 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.

Study & Design

Study Type
interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Change in hippocampal subregion cornu ammonis (CA) 4 volume between V1 and V3 (?CA4/DG) (before and after exercise intervention) and its correlation with polygenetic risk factor (PRS)
Secondary Outcome Measures
NameTimeMethod
Change (V3-V2-V1) in neurocognitive test scores, psychopathological symptomatology, functioning, quality of life, vital signs, brain structures and functions (MRI), metabolic parameters, genome-wide micro-RNA, HDAC1 and gene expression, proteins, brain-derived neurotrophic factor (BDNF) levels in plasma, investigation of the influence of genes on symptomatology, cognition, brain structure and function. Furthermore, effects of sub-PRSs of two synapse-associated pathways and comparison with pathways of neuronal cell bodies and perikaryon to prove specificity for synaptic pathways.
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