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

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.

Study Overview

• Status: Completed
• Conditions: Major Depressive Disorder
• Intervention / Treatment: Behavioral: Sudarshan Kriya Yoga

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.

• Study Type: Interventional
• Enrollment (Actual): 25
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • Mood & Anxiety Disorders Research and Treatment Program

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 67 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Waitlist Control
Experimental: Sudarshan Kriya Yoga	Behavioral: Sudarshan Kriya Yoga; A manual-based yoga program featuring a yoga-breathing meditation technique

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
17-item Hamilton Depression Rating Scale	Baseline to 2 month

Secondary Outcome Measures

Outcome Measure	Time Frame
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 Outcome Measures

Outcome Measure	Time Frame
Serum Inflammatory Markers	Baseline, 1 month, 2 month

Collaborators and Investigators

• Sponsor: University of Pennsylvania

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: October 1, 2014
• Primary Completion (Actual): December 1, 2015
• Study Completion (Actual): December 1, 2015

Study Registration Dates

• First Submitted: November 23, 2015
• First Submitted That Met QC Criteria: November 24, 2015
• First Posted (Estimate): November 30, 2015

Study Record Updates

• Last Update Posted (Estimate): December 8, 2015
• Last Update Submitted That Met QC Criteria: December 7, 2015
• Last Verified: December 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Mood Disorders; Depression; Depressive Disorder; Depressive Disorder, Major
• Other Study ID Numbers: 820672