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

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.

Method: Patients with MDD (defined by DSM-IV-TR) 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 Beck Anxiety Inventory (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.

Conclusion: 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