Yoav Domany1, Maya Bleich-Cohen2, Ricardo Tarrasch3, Roi Meidan4, Olga Litvak-Lazar5, Nadav Stoppleman6, Shaul Schreiber7, Miki Bloch8, Talma Hendler9, Haggai Sharon10. 1. Senior Psychiatrist,Department of Psychiatry,Tel Aviv Sourasky Medical Center and Sackler School of Medicine,Tel Aviv University,Israeland Postdoctoral Research Fellow,Department of Psychiatry and Behavioral Neuroscience,University of Cincinnati,USA. 2. Senior Researcher,Sagol Brain Institute Tel-Aviv Sourasky Medical Center and Clinical Manager,Brainsway Ltd,Israel. 3. Psychologist, Researcher,Statistician and Educator,Assistant Professor,School of Education and School of Neuroscience,Tel Aviv University,Israel. 4. Physician for Emergency Medicine,Department of Emergency Medicine,Tel Aviv Sourasky Medical Centre,Israel. 5. Research Coordinator,Department of Psychiatry,Tel Aviv Sourasky Medical Centre,Israel. 6. Researcher, Center for Brain Functions Wohl Institute for Advanced Imaging,Tel-Aviv Sourasky Medical,Israel. 7. Director, Department of Psychiatry,Tel Aviv Sourasky Medical CenterandProfessor of Psychiatry,Tel Aviv University,Sackler Faculty of Medicine and Member,Sagol School of Neuroscience,Tel Aviv University,Israel. 8. Head of Inpatient Psychiatric Ward,Tel Aviv Sourasky Medical Centre and Sackler School of Medicine,Tel Aviv University,Israel. 9. Head of Sagol Brain Institute,Wohl Institute for Advanced Imaging,Tel Aviv Sourasky Medical Center,Sackler School of Medicine and Sagol School of Neuroscience,Tel Aviv University,Israel. 10. Senior Physician,Institute of Pain Medicine,Department of Anesthesiology,Pain and Critical Care Medicine,Tel Aviv Sourasky Medical CentreandResearcher, Center for Brain Functions,Wohl Institute for Advanced Imaging,Tel-Aviv Sourasky Medical Centre and Sackler School of Medicine,Tel Aviv University,Israel and Pain Management & Neuromodulation Centre,Guy's & St Thomas' NHS Foundation Trust,UK.
Abstract
BACKGROUND:Ketamine has been demonstrated to improve depressive symptoms.AimsEvaluation 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 either1 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-Åsberg 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.Declaration of interestNone.
RCT Entities:
BACKGROUND:Ketamine has been demonstrated to improve depressive symptoms.AimsEvaluation 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-Åsberg 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.Declaration of interestNone.
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