A study of effects of Yoga Therapy on immune system functions in schizophrenia

Not Applicable

Completed

• Conditions: Health Condition 1: F202- Catatonic schizophreniaHealth Condition 2: F201- Disorganized schizophreniaHealth Condition 3: F200- Paranoid schizophreniaHealth Condition 4: F205- Residual schizophreniaHealth Condition 5: F251- Schizoaffective disorder, depressive typeHealth Condition 6: F209- Schizophrenia, unspecifiedHealth Condition 7: F203- Undifferentiated schizophrenia

• Registration Number: CTRI/2019/12/022264
• Lead Sponsor: Wellcome Trust DBT India Alliance

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2023-03-03
• Last Update Posted: 29 May 2023

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 90

Inclusion Criteria

For Patients:

1. Diagnosis of schizophrenia (DSM V).

2. Clinical Global Impression â?? Severity (CGI-S)Score equal to or more than 3.

3. Stable medication for 6 weeks.

4. Right-handedness.

5. Written informed consent.

For Healthy Controls:

1. Right-handedness.

2. Written informed consent.

Exclusion Criteria

For Patients:

1. Risk of harm to self or others.

2. Need for Electroconvulsive therapy.

3. Subjects who are already practicing/ recent practice of yoga/ meditation.

4. Recent history of high-grade fever/infection within the past 6 weeks.

5. Co-existing disease that can potentially influence immune system.

6. Treatment with medications known to affect immune system.

7. Significant neurological disorder including seizure disorder or recent head injury.

8. Family history of neurological disorder that may complicate diagnosis (for example Huntingtonâ??s chorea)

9. Co-morbid substance dependence in the past 6 months or substance abuse in the past 1month as per DSM - V, except nicotine.

10. Pregnancy or postpartum ( <6 weeks after delivery)

For Healthy Controls:

1. Diagnosis of a psychiatric disorder.

2. Family history of psychiatric disorder in any of the first-degree relatives

3. Recent history of high-grade fever/infection within the past 6 weeks

4. Co-existing disease including autoimmune/inflammatory conditions that can

potentially influence immune system

5. Treatment with medications known to affect immune systems

6. Pregnancy or postpartum

7. Co-morbid substance dependence in the past 6 months or substance abuse in the past 1month as per DSM - V, except nicotine.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Plasma levels of Interleukin (IL)-1 beta, IL-6, IL-17, IL-10, Complement (C)3, C4 and C5Timepoint: Baseline and <br/ ><br>3 month

Secondary Outcome Measures

Name	Time	Method
Expression of Interleukin (IL)-1 beta, IL-6, IL-17, IL-10, Complement (C)3, C4 and C5 gene in peripheral blood mononuclear cells. <br/ ><br>DNA Methylation pattern of IL-1 beta, IL-6, IL-17, IL-10, C3, C4 and C5 gene in peripheral lymphocytes. <br/ ><br>Brief Cognitive Assessment Tool <br/ ><br>Social Occupational Functioning Scale.Timepoint: Baseline and <br/ ><br>3 month