A Breathing-Based Meditation Intervention for Patients With Major Depressive Disorder Following Inadequate Response to Antidepressants: A Randomized Pilot Study

Abstract

Objective: To evaluate feasibility, efficacy, and tolerability of Sudarshan Kriya yoga (SKY) as an adjunctive intervention in patients with major depressive disorder (MDD) with inadequate response to antidepressant treatment.

Methods: Patients with MDD (defined by DSM-IV-TR) who were depressed despite ≥ 8 weeks of antidepressant treatment were randomized to SKY or a waitlist control (delayed yoga) arm for 8 weeks. The primary efficacy end point was change in 17-item Hamilton Depression Rating Scale (HDRS-17) total score from baseline to 2 months. The key secondary efficacy end points were change in Beck Depression Inventory (BDI) and Beck Anxiety Inventory (BAI) total scores. Analyses of the intent-to-treat (ITT) and completer sample were performed. The study was conducted at the University of Pennsylvania between October 2014 and December 2015.

Results: In the ITT sample (n = 25), the SKY arm (n = 13) showed a greater improvement in HDRS-17 total score compared to waitlist control (n = 12) (-9.77 vs 0.50, P = .0032). SKY also showed greater reduction in BDI total score versus waitlist control (-17.23 vs -1.75, P = .0101). Mean changes in BAI total score from baseline were significantly greater for SKY than waitlist (ITT mean difference: -5.19; 95% CI, -0.93 to -9.34; P = .0097; completer mean difference: -6.23; 95% CI, -1.39 to -11.07; P = .0005). No adverse events were reported.

Conclusions: Results of this randomized, waitlist-controlled pilot study suggest the feasibility and promise of an adjunctive SKY-based intervention for patients with MDD who have not responded to antidepressants.

Trial registration: ClinicalTrials.gov identifier: NCT02616549.

Conflict of interest statement

Potential conflicts of interest: Dr. Thase has received grants from Agency for Healthcare Research and Quality, Alkermes, Forest, National Institute of Mental Health, Otsuka, PharmaNeuroboost and Roche; has acted as an advisor or consultant for Alkermes, AstraZeneca, Bristol-Myers Squibb, Cerecor, Eli Lilly, Forest, Gerson Lehman Group, GlaxoSmithKline, Guidepoint Global, Lundbeck, MedAvante, Merck, Neuronetics, Novartis, Ortho-McNeil, Otsuka, Pamlab, Pfizer, Shire, Sunovion and Takeda. Drs. Sharma, Barrett, Cucchiara and Gooneratne have no potential conflicts to disclose.

© Copyright 2016 Physicians Postgraduate Press, Inc.

Figures

Figure 1. Study Design and Patient Disposition

Abbreviations: HDRS-17 = 17-item Hamilton Depression Rating Scale, ITT= intent-to-treat.

Figure 2. Mean Change from Baseline in HDRS-17 Score

aBaseline HDRS-17 total scores were 22.0 for SKY (n=13, ITT sample) and 18.6 for waitlist control (n=12) groups. bP values are based on mixed model repeated-measures analysis. Abbreviations: HDRS-17 = 17-item Hamilton Depression Rating Scale, ITT= intent-to-treat, SE=standard error.