A Breathing-Based Meditation Intervention for Patients With Major Depressive Disorder Following Inadequate Response to Antidepressants: A Randomized Pilot Study. Author: Sharma A1,2, Barrett MS2, Cucchiara AJ3, Gooneratne NS4, Thase ME2 Affiliation: <sup>1</sup>Department of Psychiatry, University of Pennsylvania School of Medicine, 10th Floor, Gates Bldg, 3400 Spruce St, Philadelphia, PA 19104. anup@mail.med.upenn.edu. <sup>2</sup>Department of Psychiatry, University of Pennsylvania, Philadelphia, Pennsylvania, USA. <sup>3</sup>Department of Biostatistics and Epidemiology, University of Pennsylvania, Philadelphia, Pennsylvania, USA. <sup>4</sup>Division of Geriatric Medicine, University of Pennsylvania, Philadelphia, Pennsylvania, USA. Conference/Journal: J Clin Psychiatry. Date published: 2016 Nov 22 Other: Special Notes: doi: 10.4088/JCP.16m10819. [Epub ahead of print] , Word Count: 238 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. PMID: 27898207 DOI: 10.4088/JCP.16m10819