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

Primary Purpose

Schizophrenia

Status

Completed

Phase

Not Applicable

Locations

India

Study Type

Interventional

Intervention

Yoga arm

About this trial

This is an interventional treatment trial for Schizophrenia focused on measuring Schizophrenia, Yoga, fMRI

Eligibility Criteria

18 Years - 45 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

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)

Exclusion Criteria:

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 -

Sites / Locations

National Institute of Mental Health and Neurosciences

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

Yoga arm

Control arm

Arm 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.

Healthy volunteers who will not receive yoga.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

NCT ID

NCT03379480

First Posted

December 15, 2017

Last Updated

August 27, 2020

Sponsor

National Institute of Mental Health and Neuro Sciences, India

Collaborators

SCARF (Schizophrenia Research Foundation ,India) Schizophrenia

1. Study Identification

Unique Protocol Identification Number

NCT03379480

Brief Title

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

Acronym

SATYAM

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2020

Overall Recruitment Status

Completed

Study Start Date

November 11, 2016 (Actual)

Primary Completion Date

June 2020 (Actual)

Study Completion Date

June 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

National Institute of Mental Health and Neuro Sciences, India

Collaborators

SCARF (Schizophrenia Research Foundation ,India) Schizophrenia

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Schizophrenia

Keywords

Schizophrenia, Yoga, fMRI

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

96 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Yoga arm

Arm Type

Active Comparator

Arm Description

Arm Title

Control arm

Arm Type

No Intervention

Arm Description

Healthy volunteers who will not receive yoga.

Intervention Type

Behavioral

Intervention Name(s)

Yoga arm

Intervention Description

Yoga module developed for patients with Schizophrenia

Primary Outcome Measure Information:

Title

Improvement in negative symptoms in patients with schizophrenia

Description

Time Frame

At the end of 12 weeks of yoga

Secondary Outcome Measure Information:

Title

fMRI changes

Description

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.

Time Frame

At the end of 12weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

45 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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) Exclusion Criteria: 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 -

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Naren P Rao, MD

Organizational Affiliation

National Institute of Mental Health and Neuro Sciences, India

Official's Role

Principal Investigator

Facility Information:

Facility Name

National Institute of Mental Health and Neurosciences

City

Bangalore

State/Province

Karnataka

ZIP/Postal Code

560029

Country

India

12. IPD Sharing Statement

Plan to Share IPD

Undecided

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

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