Multicomponent Yoga Intervention for Major Depressive Disorder
A Randomized Study of a Comprehensive Yoga Intervention for Patients With Major Depressive Disorder With Incomplete Response to Antidepressants
1 other identifier
interventional
25
1 country
1
Brief Summary
The purpose of this study is to evaluate the efficacy of a multi-component yoga intervention featuring Sudarshan Kriya Yoga (SKY) as an adjunctive treatment for patients with Major Depressive Disorders with incomplete response to antidepressants.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2 major-depressive-disorder
Started Oct 2014
Shorter than P25 for phase_2 major-depressive-disorder
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2014
CompletedFirst Submitted
Initial submission to the registry
November 23, 2015
CompletedFirst Posted
Study publicly available on registry
November 30, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2015
CompletedDecember 8, 2015
December 1, 2015
1.2 years
November 23, 2015
December 7, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
17-item Hamilton Depression Rating Scale
Baseline to 2 month
Secondary Outcomes (3)
Beck Depression Inventory
Baseline to 2 month
Beck Anxiety Inventory
Baseline to 2 month
Columbia Suicide Severity Rating Scale
Baseline, 1 month, 2 month
Other Outcomes (1)
Serum Inflammatory Markers
Baseline, 1 month, 2 month
Study Arms (2)
Sudarshan Kriya Yoga
EXPERIMENTALWaitlist Control
NO INTERVENTIONInterventions
A manual-based yoga program featuring a yoga-breathing meditation technique
Eligibility Criteria
You may qualify if:
- DSM-IV Major Depressive Disorder
- Able to give informed consent
- Aged 18-67
- Currently in outpatient care for MDD
- On a stable antidepressant regimen for at least 2 months
- item Hamilton Depression Score \>14 at screening \& baseline visit
You may not qualify if:
- Currently in crisis requiring inpatient treatment
- Bipolar Disorder, Psychotic Disorder, ADHD, Substance Use Disorder
- Pregnancy, Epilepsy
- Initiating psychotherapy or other yoga/meditation program
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Mood & Anxiety Disorders Research and Treatment Program
Philadelphia, Pennsylvania, 19104, United States
Related Publications (1)
Sharma A, Barrett MS, Cucchiara AJ, Gooneratne NS, Thase ME. A Breathing-Based Meditation Intervention for Patients With Major Depressive Disorder Following Inadequate Response to Antidepressants: A Randomized Pilot Study. J Clin Psychiatry. 2017 Jan;78(1):e59-e63. doi: 10.4088/JCP.16m10819.
PMID: 27898207DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 23, 2015
First Posted
November 30, 2015
Study Start
October 1, 2014
Primary Completion
December 1, 2015
Study Completion
December 1, 2015
Last Updated
December 8, 2015
Record last verified: 2015-12