A study to look at the use of yoga as a treatment in patients with mental illness (schizophrenia).

Completed

Conditions: Schizophrenia,

Registration Number: CTRI/2017/08/009505

Lead Sponsor: Department of science and technology

Brief Summary: 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.

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 250

Inclusion Criteria

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:â€‹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.

Exclusion Criteria

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.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Improvement in Negative symptoms of schizophrenia	6 weeks of intervention \| 12 weeks of intervention

Secondary Outcome Measures

Name	Time	Method
Improvement in positive symptoms of schizophrenia	Improvement in cognitive functions

Trial Locations

Locations (2): National Institute of Mental Health and Neurosciences
🇮🇳
Bangalore, KARNATAKA, India
SCARF (Schizophrenia Research Foundation ,India)
🇮🇳
Chennai, TAMIL NADU, India
National Institute of Mental Health and Neurosciences
🇮🇳Bangalore, KARNATAKA, India
Dr Naren Rao
Principal investigator
narenrao@nimhans.ac.in