Clinical trial NCT02616549: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Major Depressive Disorder
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
First posted: 2015-11-30
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Maximum age (years): 67
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: 17-item Hamilton Depression Rating Scale
timeFrame: Baseline to 2 month
Secondary outcomes:
measure: Beck Depression Inventory
timeFrame: Baseline to 2 month
measure: Beck Anxiety Inventory
timeFrame: Baseline to 2 month
measure: Columbia Suicide Severity Rating Scale
timeFrame: Baseline, 1 month, 2 month
Other outcomes:
measure: Serum Inflammatory Markers
timeFrame: Baseline, 1 month, 2 month
Locations:
city: Philadelphia
country: United States
facility: Mood & Anxiety Disorders Research and Treatment Program
state: Pennsylvania
Study officials:
References:
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.