Examination of therapeutic efficacy and potential mechanisms of yoga treatment in schizophrenia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 250
- 试验地点
- 2
- 主要终点
- Improvement in Negative symptoms of schizophrenia
研究概览
简要总结
The goals of this study is to examine whether yoga is efficacious as an add-on treatment in patients with schizophrenia in a randomised multi-centric trial. We would recruit 250 patients over a period of 3 years. Consenting subjects will be randomized to yoga therapy or wait-list control group. Those who are randomized to yoga will receive 12 weeks of yoga. Those who are randomized to wait-list control group will receive yoga after 12 weeks of waiting period. Standardized clinical assessments will be conducted by trained individuals to examine the changes in symptoms of schizophrenia. A subset of subjects will also undergo fMRI scans at baseline and after 12 weeks of intervention. All subjects will undergo uniform assessments at baseline and after 12 weeks. Those who are in waitlist control group will also undergo repeat assessment at the end of 24 weeks. The effect of yoga treatment compared to waitlist control group will be analysed to see the effect of yoga on symptoms of schizophrenia.
研究设计
- 研究类型
- Interventional
- 分配方式
- Stratified randomization
- 盲法
- Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 45.00 Year(s)（—）
- 性别
- All
入选标准
- •Schizophrenia Subject 1)ICD 10diagnosisof schizophrenia 2) capacity to provide informed consent 3)no other current comorbid axis I diagnosis (except nicotine abuse/dependence) and no general impaired intellectual functioning Healthy volunteers:​1) Males and females between 18 and 45 years 2)Capacity to provide informed consent 3) absence of past or present psychiatric illnesses including substance abuse 4) no general impaired intellectual functioning.
排除标准
- •Exclusion criteria for both Patients and controls 1)Other current comorbid axis I diagnosis (except nicotine abuse/dependence) and general impaired intellectual functioning 2) History of alcohol or substance abuse or dependence in the last 12 months (with the exception of nicotine) 3)Past history of head injury resulting in loss of consciousness or neurosurgery 4)Concomitant severe medical conditions 5)Change in dose of antipsychotic medication or Electroconvulsive therapy in the past 6weeks 6)Pregnant or lactating.
结局指标
主要结局
Improvement in Negative symptoms of schizophrenia
时间窗: 6 weeks of intervention | 12 weeks of intervention
次要结局
- Improvement in positive symptoms of schizophrenia(Improvement in cognitive functions)