Study on Examination of Therapeutic Efficacy and Potential Mechanisms of Yoga Treatment in Schizophrenia (SATYAM)

National Institute of Mental Health and Neuro Sciences, India

Status: Completed

Conditions: Schizophrenia

Treatments: Behavioral: Yoga arm

Study type: Interventional

Funder types: Other

Identifiers

NCT03379480

DST/002/208/2016/00892

Details and patient eligibility

About

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.

Enrollment: 96 patients

Sex: All

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

Schizophrenia Subject

1. ICD (International Classification of Diseases) 10 diagnosis of schizophrenia
2. capacity to provide informed consent, as evaluated by the MacArthur Competence Assessment Tool for Clinical Research
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 (MMSE above24)

Exclusion criteria

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. Any Contraindication to MRI like metal implants or paramagnetic objects within the body or claustrophobia (only for patients undergoing fMRI at NIMHANS)
4. Past history of head injury resulting in loss of consciousness or neurosurgery
5. Concomitant severe medical conditions
6. Change in dose of antipsychotic medication or Electroconvulsive therapy in the past 6weeks
7. Pregnant or lactating -

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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96 participants in 2 patient groups

Yoga arm

Active Comparator group

Description:

Patients with Schizophrenia will undergo 12 sessions of yoga. According to randomization one group of patients will start yoga immediately after recruitment ,whereas another group will go into wait list for 12 weeks after which they will also undergo Yoga treatment.

Treatment:

Behavioral: Yoga arm

Control arm

No Intervention group

Description:

Healthy volunteers who will not receive yoga.