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

Not Applicable

Completed

• Conditions: Schizophrenia

• Registration Number: NCT03379480
• Lead Sponsor: National Institute of Mental Health and Neuro Sciences, India

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-11-11
• Study First Submitted: 2017-12-15
• Study First Submitted QC: 2017-12-15
• Study First Posted: 2017-12-20
• Primary Completion: 2020-06
• Study Completion: 2020-06
• Status Verified: 2020-08
• Last Update Submitted: 2020-08-27
• Last Update Posted: 2020-08-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 96

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 -

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Improvement in negative symptoms in patients with schizophrenia	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.

Secondary Outcome Measures

Name	Time	Method
fMRI changes	At the end of 12weeks	Schizophrenia patients receiving yoga will have higher activation in Medial prefrontal cortex after yoga therapy compared to baseline and compared to those in the wait-list group at 12 weeks.

Trial Locations

Locations (1)

National Institute of Mental Health and Neurosciences; 🇮🇳 Bangalore, Karnataka, India