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Trial record 6 of 2922 for:    "Schizophrenia"

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

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ClinicalTrials.gov Identifier: NCT03379480
Recruitment Status : Recruiting
First Posted : December 20, 2017
Last Update Posted : December 20, 2017
Sponsor:
Collaborator:
SCARF (Schizophrenia Research Foundation ,India) Schizophrenia
Information provided by (Responsible Party):
Dr Naren P Rao, National Institute of Mental Health and Neuro Sciences, India

Brief Summary:
Despite the preliminary evidence, yoga as a treatment for schizophrenia is under-examined.Studies in healthy individuals indicate yoga practices to improveself-reflection. However, whether yoga treatment improves impairments in self- reflection typically seen in patients with schizophrenia is not examined. Hence, In this study we aim to examine whether yoga is efficacious as an add-on treatment in Schizophrenia in a randomized multi-centric trial and also whether yoga improves self-reflection in patients with schizophrenia.

Condition or disease Intervention/treatment Phase
Schizophrenia Behavioral: Yoga arm Not Applicable

Detailed Description:

Despite the preliminary evidence, yoga as a treatment for schizophrenia is under-examined.Importantly, till date no randomized multi-centric trial has examined the efficacy of yoga as an addon treatment for schizophrenia which seriously limits the application of yoga in clinical practice.Moreover, the underlying mechanism by which yoga improves the symptoms of schizophrenia is not completely understood.

Studies in healthy individuals indicate yoga practices to improveself-reflection. However, whether yoga treatment improves impairments in self- reflection typically seen in patients with schizophrenia is not examined.

Thus, the overall goals of this proposal is to examine

  1. whether yoga as is efficacious as an add-on treatment in patients with schizophrenia in a randomised multi-centric trial
  2. whether yoga improves self-reflection in patients with schizophrenia.

To achieve the first aim we aim to examine the efficacy of yoga as an add on treatment to schizophrenia in a multicentric single blind-randomized-control-trial. Five centers would recruit 50 patients each making a cumulative sample of 250 patients. Such a large sample would have the required power to examine the efficacy of yoga as a treatment to schizophrenia. A central stratified random sampling will be used to ensure concealed allocation. Subjects will be randomized to yoga therapy or wait-list control group. Those who are randomized to yoga will receive 12 weeks of yoga. Those who are randomized to wait-list control group will receive yoga after 12 weeks of waiting period. Standardized clinical assessments will be conducted by trained individuals to examine the changes in symptoms of schizophrenia. All subjects will undergo uniform assessments at baseline and after 12 weeks. Those who are in waitlist control group will also undergo assessment at the end of 24 weeks. The effect of yoga treatment compared to waitlist control group will be analysed to see the effect of yoga on symptoms of schizophrenia.

To achieve the second aim (i) we will develop and employ behavioural scale to measure changes in self-reflection based on yoga psychology - Scale for Assessment of Self-reflection. The scale will be developed based on the yoga psychology. The scale would measure the dimensions of self-centrality, body-centrality, cognitive-centrality and content of experience. The scale would be developed at National Institute of Advanced studies and validated at clinical centres. Scale will be administered to a sample of 250 healthy controls and 250 patients (ii) we plan to obtain first in-vivo functional neuroimaging data using functional magnetic resonance imaging(fMRI) to investigate neurobiological effects of yoga treatment in brain regions associated with self reflection. A validated fMRI task which has been used ins chizophrenia patients earlier will be used in the proposed study. The task specifically examines the brain regions involved in the self- reflection ability. A subgroup of patients (n=40) and healthy controls (n=20) at NIMHANS, Bangalore will undergo fMRI scan. 20 patients receiving yoga treatment and 20 patients in wait list control group will undergo fMRI scan before and after 12 weeks to examine the changes in brain activation after yoga treatment. Put together, this unique study brings together experts from psychiatry, philosophy, psychology and neuroimaging, which are complementary to understand the efficacy and mechanism of yoga in Schizophrenia.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Examination of Therapeutic Efficacy and Potential Mechanisms of Yoga Treatment in Schizophrenia
Actual Study Start Date : November 11, 2016
Estimated Primary Completion Date : November 2018
Estimated Study Completion Date : November 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Schizophrenia

Arm Intervention/treatment
Active Comparator: 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.
Behavioral: Yoga arm
Yoga module developed for patients with Schizophrenia

No Intervention: Control arm
Healthy volunteers who will not receive yoga.



Primary Outcome Measures :
  1. Improvement in negative symptoms in patients withschizophrenia [ 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 greater decrease in Scale for Assessment of negative symptoms score]

    2. Schizophrenia patients will have lower activation in medial prefrontal cortex and lower scores on scale for assessment of self-reflection compared to controls



Secondary Outcome Measures :
  1. fMRI changes [ Time Frame: At the end of 12weeks ]
    1. 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.
    2. Schizophrenia patients will have higher scores on scale for assessment of self reflection (which will be developed during study)after yoga therapy compared to baseline and to those in wait list group at 12 weeks.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

Schizophrenia Subject

  1. ICD 10 diagnosis of schizophrenia
  2. capacity to provide informed consent, as evaluated by the MacArthur Competence Assessment Tool for Clinical Research(MacCAT)(Appel baumand Grisso1995);
  3. no other current comorbid axis I diagnosis (except nicotine abuse/dependence) and no general impaired intellectual functioning (Mini-Mental Status Exam, (Folstein, Folstein et al. 1975) MMSE above 24 )

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:

Exclusion criteria for both Patients and controls

  1. Other current comorbid axis I diagnosis (except nicotine abuse/dependence) and general impaired intellectual functioning (Mini-Mental Status Exam, (Folstein, Folstein et al. 1975) MMSE below24),
  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 with in 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 -

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03379480


Contacts
Contact: Dr Naren P Rao, MBBS,MD 9448342379 narenrao@nimhans.ac.in
Contact: Dr.Shivaram Varambally, MBBS,MD 0802699 ext 5253 drvarambally@gmail.com

Locations
India
National Institute of Mental Health and Neurosciences Recruiting
Bangalore, Karnataka, India, 560029
Contact: Naren P Rao, M.B.B.S,MD    9448342379    narenrao@nimhans.ac.in   
Sponsors and Collaborators
National Institute of Mental Health and Neuro Sciences, India
SCARF (Schizophrenia Research Foundation ,India) Schizophrenia
Investigators
Principal Investigator: Dr Naren P Rao, MBBS,MD National Institute of Mental Health and Neuro Sciences, India

Responsible Party: Dr Naren P Rao, Associate Professor ,Department of Psychiatry, NIMHANS, National Institute of Mental Health and Neuro Sciences, India
ClinicalTrials.gov Identifier: NCT03379480     History of Changes
Other Study ID Numbers: DST/002/208/2016/00892
First Posted: December 20, 2017    Key Record Dates
Last Update Posted: December 20, 2017
Last Verified: December 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Dr Naren P Rao, National Institute of Mental Health and Neuro Sciences, India:
Schizophrenia, Yoga, fMRI, self reflection, efficacy

Additional relevant MeSH terms:
Schizophrenia
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders