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

NCT ID: NCT03379480

Last Updated: 2020-08-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

96 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-11-11

Study Completion Date

2020-06-30

Brief Summary

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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

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Conditions

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Schizophrenia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Yoga arm

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.

Group Type ACTIVE_COMPARATOR

Yoga arm

Intervention Type BEHAVIORAL

Yoga module developed for patients with Schizophrenia

Control arm

Healthy volunteers who will not receive yoga.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Yoga arm

Yoga module developed for patients with Schizophrenia

Intervention Type BEHAVIORAL

Eligibility Criteria

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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 -
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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SCARF (Schizophrenia Research Foundation ,India) Schizophrenia

UNKNOWN

Sponsor Role collaborator

National Institute of Mental Health and Neuro Sciences, India

OTHER

Sponsor Role lead

Responsible Party

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Dr Naren P Rao

Associate Professor ,Department of Psychiatry, NIMHANS

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Naren P Rao, MD

Role: PRINCIPAL_INVESTIGATOR

National Institute of Mental Health and Neuro Sciences, India

Locations

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National Institute of Mental Health and Neurosciences

Bangalore, Karnataka, India

Site Status

Countries

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India

Other Identifiers

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DST/002/208/2016/00892

Identifier Type: -

Identifier Source: org_study_id

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