Repeated oral ketamine for out-patient treatment of resistant depression: randomised, double-blind, placebo-controlled, proof-of-concept study
| Autor: | Haggai Sharon, Nadav Stoppleman, Maya Bleich-Cohen, Olga Litvak-Lazar, Roi Meidan, Ricardo Tarrasch, Miki Bloch, Talma Hendler, Yoav Domany, Shaul Schreiber |
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| Rok vydání: | 2018 |
| Předmět: |
Placebo
Drug Administration Schedule law.invention Double blind Depressive Disorder Treatment-Resistant 03 medical and health sciences 0302 clinical medicine Double-Blind Method Randomized controlled trial Rating scale law Outpatients Humans Medicine Ketamine 030212 general & internal medicine Depression (differential diagnoses) Randomized Controlled Trials as Topic business.industry medicine.disease 030227 psychiatry Psychiatry and Mental health Treatment Outcome Anesthesia Number needed to treat business Excitatory Amino Acid Antagonists Treatment-resistant depression medicine.drug |
| Zdroj: | British Journal of Psychiatry. 214:20-26 |
| ISSN: | 1472-1465 0007-1250 |
| DOI: | 10.1192/bjp.2018.196 |
| Popis: | BackgroundKetamine 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).MethodIn 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).ResultsTwenty-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.ConclusionsRepeated 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. |
| Databáze: | OpenAIRE |
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