Skip to main content
OpenTrials
Completed

NCT Number: NCT03379480

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Schizophrenia Mental Disorders Schizophrenia Spectrum and Other Psychotic Disorders

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

National Institute of Mental Health and Neurosciences

Bangalore, Karnataka, 560029, India

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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 -

Treatment and study plan

Yoga arm

Behavioral

Yoga module developed for patients with Schizophrenia

Primary outcomes

  1. Improvement in negative symptoms in patients with schizophrenia

    Time frame: 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 outcomes

  1. fMRI changes

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

National Institute of Mental Health and Neuro Sciences, India

Other

Collaborators

  • SCARF (Schizophrenia Research Foundation ,India) Schizophrenia

Registry information

Official study title

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

Acronym: SATYAM

Important dates

Study start
2016
Primary completion
2020
Study completion
2020
First posted
Dec 20, 2017
Registry last updated
Aug 28, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.