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Multicomponent Yoga Intervention for Major Depressive Disorder

Primary Purpose

Major Depressive Disorder

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Sudarshan Kriya Yoga
Sponsored by
University of Pennsylvania
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Major Depressive Disorder

Eligibility Criteria

18 Years - 67 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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
  • 17-item Hamilton Depression Score >14 at screening & baseline visit

Exclusion Criteria:

  • Currently in crisis requiring inpatient treatment
  • Bipolar Disorder, Psychotic Disorder, ADHD, Substance Use Disorder
  • Pregnancy, Epilepsy
  • Initiating psychotherapy or other yoga/meditation program

Sites / Locations

  • Mood & Anxiety Disorders Research and Treatment Program

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Sudarshan Kriya Yoga

Waitlist Control

Arm Description

Outcomes

Primary Outcome Measures

17-item Hamilton Depression Rating Scale

Secondary Outcome Measures

Beck Depression Inventory
Beck Anxiety Inventory
Columbia Suicide Severity Rating Scale

Full Information

First Posted
November 23, 2015
Last Updated
December 7, 2015
Sponsor
University of Pennsylvania
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1. Study Identification

Unique Protocol Identification Number
NCT02616549
Brief Title
Multicomponent Yoga Intervention for Major Depressive Disorder
Official Title
A Randomized Study of a Comprehensive Yoga Intervention for Patients With Major Depressive Disorder With Incomplete Response to Antidepressants
Study Type
Interventional

2. Study Status

Record Verification Date
December 2015
Overall Recruitment Status
Completed
Study Start Date
October 2014 (undefined)
Primary Completion Date
December 2015 (Actual)
Study Completion Date
December 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Pennsylvania

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
According to the World Health Organization, compared to two hundred health conditions, depression is ranked as the second leading cause of disability worldwide. The annual prevalence of Major Depressive Disorder (MDD) in the United States is estimated at 7% and the lifetime risk approximately 17%. Depression is associated with approximately 75% of all deaths by suicide, resulting in immense suffering for families and society at large. 83 billion dollars are spent per year on treatment and lost productivity related to the disorder. Current treatments for MDD have remission rates between 35-50%. Patients who respond to treatment, but do not experience clinical remission are at markedly increased risk for relapse. Approximately 50% of patients treated with two trials of antidepressant interventions do not achieve clinical remission. Consequently, novel evidence-based treatment modalities that can further treat this devastating disorder are needed. Mind-body interventions constitute a large and diverse group of practices that reduce both stress and inflammation and are increasingly being evaluated in the treatment of MDD The 2007 NHIS concluded that 16.6% of U.S. adults, representing 34.1 million Americans, used at least one mind-body intervention in the past year. Initial studies with different mind-body interventions have been shown to improve outcomes in MDD. A recent meta-analysis gave a Grade B for current evidence for the use of yoga as an intervention for MDD. Sudarshan Kriya Yoga (SKY) is a advanced yogic breathing intervention that has been reported to relieve symptoms of major depressive disorder and generalized anxiety disorder. In MDD, SKY can correct the P300 amplitude, decrease plasma cortisol levels and increase plasma prolactin levels. In a small-scale randomized controlled trial, 45 consenting inpatients meeting criteria for DSM-IV severe, melancholic depression were randomized to receive SKY, electroconvulsive therapy (ECT) or imipramine treatment for four weeks (Janakiramaiah et al. 2000). Consequently, the rigorous evaluation of a multicomponent yogic intervention featuring SKY as an adjunctive treatment for adults with MDD warrants further study.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Major Depressive Disorder

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
25 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Sudarshan Kriya Yoga
Arm Type
Experimental
Arm Title
Waitlist Control
Arm Type
No Intervention
Intervention Type
Behavioral
Intervention Name(s)
Sudarshan Kriya Yoga
Intervention Description
A manual-based yoga program featuring a yoga-breathing meditation technique
Primary Outcome Measure Information:
Title
17-item Hamilton Depression Rating Scale
Time Frame
Baseline to 2 month
Secondary Outcome Measure Information:
Title
Beck Depression Inventory
Time Frame
Baseline to 2 month
Title
Beck Anxiety Inventory
Time Frame
Baseline to 2 month
Title
Columbia Suicide Severity Rating Scale
Time Frame
Baseline, 1 month, 2 month
Other Pre-specified Outcome Measures:
Title
Serum Inflammatory Markers
Time Frame
Baseline, 1 month, 2 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
67 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 17-item Hamilton Depression Score >14 at screening & baseline visit Exclusion Criteria: Currently in crisis requiring inpatient treatment Bipolar Disorder, Psychotic Disorder, ADHD, Substance Use Disorder Pregnancy, Epilepsy Initiating psychotherapy or other yoga/meditation program
Facility Information:
Facility Name
Mood & Anxiety Disorders Research and Treatment Program
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
27898207
Citation
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.
Results Reference
derived

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Multicomponent Yoga Intervention for Major Depressive Disorder

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