Suicidal Ideation Clinical Trial
Official title:
Evaluation of the Effects of Ketamine in the Acute Phase of Suicidal Ideation: a Multicenter Randomized Double-blind Trial
The primary objective of this study is to assess the efficacy of ketamine versus a placebo for the short-term (at 72h, i.e. 24h after the last perfusion) relief of suicidal ideation, measured using the BSS hetero questionnaire, in patients hospitalized for suicide risk.
The secondary objectives of this study are to assess:
A. The maintenance of medium-term effectiveness of ketamine on the resolution of suicidal
ideation
B. The evolution of the full spectrum of suicidality under ketamine compared to placebo
C. The evolution of psychic and physical pain scores under ketamine compared to placebo
D. The evolution of Beck Hopelessness score which is a predictor of long-term suicide risk,
under ketamine compared to placebo
E. The early antidepressant efficacy of ketamine in depressed, uni- or bipolar patients
F. The somatic and psychological tolerance of ketamine
G. An overall improvement in the clinical condition of the patient by the practitioner
H. Creation of a biological collection for future ancillary studies dedicated to genetic
analysis (microRNA and mRNA).
I. The efficacy of ketamine versus a placebo for the short-term (at 72h, i.e. 24h after the
last perfusion) relief of suicidal ideation, measured using the BSS self-report
questionnaire, in patients hospitalized for suicide risk.
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