Journal
BRITISH JOURNAL OF PSYCHIATRY
Volume 214, Issue 1, Pages 20-26Publisher
CAMBRIDGE UNIV PRESS
DOI: 10.1192/bjp.2018.196
Keywords
Depressive disorders; antidepressants; ketamine; treatment resistant depression; randomized controlled trial
Categories
Funding
- Tel Aviv Medical Center Brain Grant 2016
- NARSAD Young Investigator Award, Brain&Behavior Research Foundation
- Oxley Foundation
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Background Ketamine has been demonstrated to improve depressive symptoms. Aims Evaluation of efficacy, safety and feasibility of repeated oral ketamine for out-patients with treatment-resistant depression (TRD). Method In a randomised, double-blind, placebo-controlled, proof-of-concept trial, 41 participants received either 1 mg/kg oral ketamine or placebo thrice weekly for 21 days (ClinicalTrials.gov Identifier: NCT02037503). Evaluation was performed at baseline, 40 and 240 min post administration and on days 3, 7, 14 and 21. The main outcome measure was change in Montgomery-Asberg Depression Rating Scale (MADRS). Results Twenty-two participants were randomised to the ketamine group, and 19 to the control, with 82.5% (n = 33) completing the study. In the ketamine group, a decrease in depressive symptoms was evident at all time points, whereas in the control group a decrease was evident only 40 min post administration. The reduction in MADRS score on day 21 was 12.75 in the ketamine group versus 2.49 points with placebo (P < 0.001). Six participants in the ketamine group (27.3%) achieved remission compared with none of the controls (P < 0.05). The number needed to treat for remission was 3.7. Side-effects were mild and transient. Conclusions Repeated oral ketamine produced rapid and persistent amelioration of depressive symptoms in out-patients with TRD, and was well tolerated. These results suggest that add-on oral ketamine may hold significant promise in the care of patients suffering from TRD in the community.
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