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

Schizophrenia Clinical Trial

— SATYAM  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03379480
• Other study ID #: DST/002/208/2016/00892
• Status: Completed
• Phase: N/A
• Start date: November 11, 2016
• Est. completion date: June 2020

Study information

• Verified date: August 2020
• Source: National Institute of Mental Health and Neuro Sciences, India
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 96
• Est. completion date: June 2020
• Est. primary completion date: June 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

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 -

Related Conditions & MeSH terms

• Schizophrenia

Intervention

Behavioral:
• Yoga arm
Yoga module developed for patients with Schizophrenia

Locations

Country	Name	City	State
India	National Institute of Mental Health and Neurosciences	Bangalore	Karnataka

Sponsors (2)

Lead Sponsor	Collaborator
National Institute of Mental Health and Neuro Sciences, India	SCARF (Schizophrenia Research Foundation ,India) Schizophrenia

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Improvement in negative symptoms in patients with schizophrenia	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.	At the end of 12 weeks of yoga
Secondary	fMRI changes	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.	At the end of 12weeks