Insight Into Hippocampal Neuroplasticity in Schizophrenia by Investigating Molecular Pathways During Physical Training
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 156
- 试验地点
- 2
- 主要终点
- Hippocampal volume
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
结局指标
主要结局
Hippocampal volume
时间窗: 13 weeks
Change in hippocampal subregion cornu ammonis (CA) 4 volume (∆CA4/DG) and its correlation with polygenetic risk factor (PRS)
次要结局
- Functioning in daily life(13 weeks)
- Symptoms severity(13 weeks)
- Cardiovascular risk factors(13 weeks)
- Cognitive functions(13 weeks)
- Executive functions(13 weeks)
研究者
Lena Deller
Doctoral Candidate
LMU Klinikum