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
- 发起方
- 入组人数
- 96
- 试验地点
- 2
- 主要终点
- Improvement in negative symptoms in patients with schizophrenia
研究概览
简要总结
The aim of this study is to examine whether yoga is efficacious as an add-on treatment for negative symptoms of schizophrenia in a randomized multi-centric trial and also to examine functional brain changes associated with self-reflection after treatment with yoga.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Schizophrenia Subject
- •ICD (International Classification of Diseases) 10 diagnosis of schizophrenia
- •capacity to provide informed consent, as evaluated by the MacArthur Competence Assessment Tool for Clinical Research
- •no other current comorbid axis I diagnosis (except nicotine abuse/dependence) and no general impaired intellectual functioning
- •Healthy volunteers:
- •Males and females between 18 and 45 years
- •Capacity to provide informed consent
- •absence of past or present psychiatric illnesses including substance abuse 4) no general impaired intellectual functioning (MMSE above24)
排除标准
- •Other current comorbid axis I diagnosis (except nicotine abuse/dependence) and general impaired intellectual functioning
- •History of alcohol or substance abuse or dependence in the last 12 months (with the exception of nicotine)
- •Any Contraindication to MRI like metal implants or paramagnetic objects within the body or claustrophobia (only for patients undergoing fMRI at NIMHANS)
- •Past history of head injury resulting in loss of consciousness or neurosurgery
- •Concomitant severe medical conditions
- •Change in dose of antipsychotic medication or Electroconvulsive therapy in the past 6weeks
- •Pregnant or lactating -
结局指标
主要结局
Improvement in negative symptoms in patients with schizophrenia
时间窗: At the end of 12 weeks of yoga
Schizophrenia patients receiving yoga as add-on treatment will have significant improvement in negative symptoms after yoga therapy compared to those in the wait-list group as reflected by a greater decrease in Scale for Assessment of negative symptoms score. This scale measures negative symptoms on a 25 item, 6-point scale. Items are listed under the five domains of affective blunting, alogia, avolition/apathy, anhedonia/asociality, and attention. A higher score indicates greater severity.
次要结局
- fMRI changes(At the end of 12weeks)
研究者
Dr Naren P Rao
Associate Professor ,Department of Psychiatry, NIMHANS
National Institute of Mental Health and Neuro Sciences, India