Intranasal Ketamine for Alleviation of Acute Suicidal Ideation. An Emergency Department, Trans-Diagnostic Approach: Randomized, Double-Blind, Placebo-Controlled, Proof-of-Concept Trial
54 Pages Posted: 9 Apr 2019More...
Background: suicidal patients are often presented to the Emergency Department, where specific treatment is lacking. Ketamine, a rapidly acting antidepressant with anti-suicidal properties might offer relief.
Methods: thirty eligible participants who suffered acute suicidal ideation and required hospitalization were randomized to intranasal ketamine 40mg or placebo, between August 2016 to April 2018. Safety and efficacy evaluations were scheduled for two and four hours, on days 1, 3, 7, and 21 post administration. Primary outcome was suicidal ideation four hours post administration. Randomization was carried out by the pharmacist while the rest of the study group was blinded.
Outcomes: Fifteen subjects were randomised for ketamine and fifteen for control, all were analyzed for primary and secondary outcomes. Four hours post administration the mean difference in suicidal symptoms between the groups, measured by the Montgomery-Åsberg Depression Rating Scale (MADRS) item of suicidal thoughts, was 1.267 (95% confident interval 0.1-2.43, P<0.05) favoring the ketamine group, with suicidal ideation remission rates of 80% of the ketamine group compares with 33% of the controls (p<0.05). The mean difference in depressive symptoms, measured by MADRS, at the same time was 9.75 (95% confident interval 0.72-18.79, P<0.05) favoring the ketamine group. The treatment was safe and well-tolerated.
Interpretation: Intranasal ketamine alleviated suicidal ideation and improved depressive symptoms four hours post ketamine administration. We present an innovative paradigm for the management of suicidal individuals in emergency setting. Future larger-scale studies are warranted to establish treatment recommendation.
Trial Registration Number: ClinicalTrials.gov Identifier: NCT02183272.
Funding Statement: This study was supported by the American Foundation of Suicide Prevention.
Declaration of Interests: All authors declare no conflict of interests.
Ethics Approval Statement: This study was reviewed and approved by the University of Cincinnati Institutional Review Board.
Keywords: suicide, ketamine, emergency department, suicidal ideation
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