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Effects of Ketamine in the Acute Phase of Suicidal Ideation (KETIS)

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ClinicalTrials.gov Identifier: NCT02299440
Recruitment Status : Completed
First Posted : November 24, 2014
Last Update Posted : May 29, 2019
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Nīmes

Tracking Information
First Submitted Date  ICMJE November 20, 2014
First Posted Date  ICMJE November 24, 2014
Last Update Posted Date May 29, 2019
Actual Study Start Date  ICMJE April 2015
Actual Primary Completion Date March 12, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 4, 2015)
BSSI score [ Time Frame: Day 3 ]
A suicidal ideation score measured using the BSS (Beck et al. 1979) in its hetero questionnaire form ≤ 3 at 24 hours after the second infusion of ketamine or placebo (yes/no). A threshold ≤ 3 separates the resolution of suicidal ideas from their persistence (Holi et al. 2005; DiazGranados et al. 2010).
Original Primary Outcome Measures  ICMJE
 (submitted: November 20, 2014)
BSSI score [ Time Frame: Day 3 ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 31, 2017)
  • The occurrence of a suicide attempt or a completed suicide (yes/no) [ Time Frame: 6 weeks ]
  • Evaluation of the full spectrum of suicidality using the CSSRS [ Time Frame: Baseline (Day-2 to Day 0) ]
  • Evaluation of the full spectrum of suicidality using the CSSRS [ Time Frame: Day 1 ]
  • Evaluation of the full spectrum of suicidality using the CSSRS [ Time Frame: Day 2 ]
  • Evaluation of the full spectrum of suicidality using the CSSRS [ Time Frame: Day 3 ]
  • Evaluation of the full spectrum of suicidality using the CSSRS [ Time Frame: Day 4 ]
  • Evaluation of the full spectrum of suicidality using the CSSRS [ Time Frame: Week 2 ]
  • Evaluation of the full spectrum of suicidality using the CSSRS [ Time Frame: Week 4 ]
  • Evaluation of the full spectrum of suicidality using the CSSRS [ Time Frame: Week 6 ]
  • The BSSI score [ Time Frame: Baseline (Day-2 to Day 0) ]
  • The BSSI score [ Time Frame: 40 min after end of 1st perfusion (Day 0) ]
  • The BSSI score [ Time Frame: 120 min after end of 1st perfusion (Day 0) ]
  • The BSSI score [ Time Frame: 4 hours after end of 1st perfusion (Day 0) ]
  • The BSSI score [ Time Frame: Day 1 ]
  • The BSSI score [ Time Frame: Day 2 ]
  • The BSSI score [ Time Frame: Day 4 ]
  • The BSSI score [ Time Frame: Week 2 ]
  • The BSSI score [ Time Frame: Week 4 ]
  • The BSSI score [ Time Frame: Week 6 ]
  • Evaluation of physical pain using a visual analog scale of 0 to 10 following a Lickert model [ Time Frame: Baseline (Day-2 to Day 0) ]
  • Evaluation of physical pain using a visual analog scale of 0 to 10 following a Lickert model [ Time Frame: 40 min after end of 1st perfusion (Day 0) ]
  • Evaluation of physical pain using a visual analog scale of 0 to 10 following a Lickert model [ Time Frame: 120 min after end of 1st perfusion (Day 0) ]
  • Evaluation of physical pain using a visual analog scale of 0 to 10 following a Lickert model [ Time Frame: 4 hours after end of 1st perfusion (Day 0) ]
  • Evaluation of physical pain using a visual analog scale of 0 to 10 following a Lickert model [ Time Frame: Day 1 ]
  • Evaluation of physical pain using a visual analog scale of 0 to 10 following a Lickert model [ Time Frame: Day 2 ]
  • Evaluation of physical pain using a visual analog scale of 0 to 10 following a Lickert model [ Time Frame: Day 3 ]
  • Evaluation of physical pain using a visual analog scale of 0 to 10 following a Lickert model [ Time Frame: Day 4 ]
  • Evaluation of physical pain using a visual analog scale of 0 to 10 following a Lickert model [ Time Frame: Week 2 ]
  • Evaluation of physical pain using a visual analog scale of 0 to 10 following a Lickert model [ Time Frame: Week 4 ]
  • Evaluation of physical pain using a visual analog scale of 0 to 10 following a Lickert model [ Time Frame: Week 6 ]
  • Evaluation of mental pain using a visual analog scale of 0 to 10 following a Lickert model [ Time Frame: Baseline (Day-2 to Day 0) ]
  • Evaluation of mental pain using a visual analog scale of 0 to 10 following a Lickert model [ Time Frame: 40 min after end of 1st perfusion (Day 0) ]
  • Evaluation of mental pain using a visual analog scale of 0 to 10 following a Lickert model [ Time Frame: 120 min after end of 1st perfusion (Day 0) ]
  • Evaluation of mental pain using a visual analog scale of 0 to 10 following a Lickert model [ Time Frame: 4 hours after end of 1st perfusion (Day 0) ]
  • Evaluation of mental pain using a visual analog scale of 0 to 10 following a Lickert model [ Time Frame: Day 1 ]
  • Evaluation of mental pain using a visual analog scale of 0 to 10 following a Lickert model [ Time Frame: Day 2 ]
  • Evaluation of mental pain using a visual analog scale of 0 to 10 following a Lickert model [ Time Frame: Day 3 ]
  • Evaluation of mental pain using a visual analog scale of 0 to 10 following a Lickert model [ Time Frame: Day 4 ]
  • Evaluation of mental pain using a visual analog scale of 0 to 10 following a Lickert model [ Time Frame: Week 2 ]
  • Evaluation of mental pain using a visual analog scale of 0 to 10 following a Lickert model [ Time Frame: Week 4 ]
  • Evaluation of mental pain using a visual analog scale of 0 to 10 following a Lickert model [ Time Frame: Week 6 ]
  • Evaluation of despair using the Beck Hopelessness Scale [ Time Frame: Baseline (Day-2 to Day 0) ]
  • Evaluation of despair using the Beck Hopelessness Scale [ Time Frame: Day 1 ]
  • Evaluation of despair using the Beck Hopelessness Scale [ Time Frame: Day 2 ]
  • Evaluation of despair using the Beck Hopelessness Scale [ Time Frame: Day 3 ]
  • Evaluation of despair using the Beck Hopelessness Scale [ Time Frame: Day 4 ]
  • Evaluation of despair using the Beck Hopelessness Scale [ Time Frame: Week 2 ]
  • Evaluation of despair using the Beck Hopelessness Scale [ Time Frame: Week 4 ]
  • Evaluation of despair using the Beck Hopelessness Scale [ Time Frame: Week 6 ]
  • Evaluation of depression by the clinician (IDS-C30) [ Time Frame: Baseline (Day-2 to Day 0) ]
  • Evaluation of depression by the clinician (IDS-C30) [ Time Frame: 4 hours after end of 1st perfusion (Day 0) ]
  • Evaluation of depression by the clinician (IDS-C30) [ Time Frame: Day 1 ]
  • Evaluation of depression by the clinician (IDS-C30) [ Time Frame: Day 2 ]
  • Evaluation of depression by the clinician (IDS-C30) [ Time Frame: Day 3 ]
  • Evaluation of depression by the clinician (IDS-C30) [ Time Frame: Day 4 ]
  • Evaluation of depression by the clinician (IDS-C30) [ Time Frame: Week 2 ]
  • Evaluation of depression by the clinician (IDS-C30) [ Time Frame: Week 4 ]
  • Evaluation of depression by the clinician (IDS-C30) [ Time Frame: Week 6 ]
  • Evaluation of somatic tolerance of ketamine using the Patient Rated Inventory of Side Effects (PRISE) throughout follow-up [ Time Frame: Baseline (Day-2 to Day 0) ]
  • Evaluation of somatic tolerance of ketamine using the Patient Rated Inventory of Side Effects (PRISE) throughout follow-up [ Time Frame: Day 1 ]
  • Evaluation of somatic tolerance of ketamine using the Patient Rated Inventory of Side Effects (PRISE) throughout follow-up [ Time Frame: Day 2 ]
  • Evaluation of somatic tolerance of ketamine using the Patient Rated Inventory of Side Effects (PRISE) throughout follow-up [ Time Frame: Day 3 ]
  • Evaluation of somatic tolerance of ketamine using the Patient Rated Inventory of Side Effects (PRISE) throughout follow-up [ Time Frame: Day 4 ]
  • Evaluation of psychic tolerance using the Young Mania Rating Scale (YMRS) [ Time Frame: Baseline (Day-2 to Day 0) ]
  • Evaluation of psychic tolerance using the Young Mania Rating Scale (YMRS) [ Time Frame: Day 1 ]
  • Evaluation of psychic tolerance using the Young Mania Rating Scale (YMRS) [ Time Frame: Day 2 ]
  • Evaluation of psychic tolerance using the Young Mania Rating Scale (YMRS) [ Time Frame: Day 3 ]
  • Evaluation of psychic tolerance using the Young Mania Rating Scale (YMRS) [ Time Frame: Day 4 ]
  • Evaluation of psychic tolerance using the Brief Psychiatric Rating Scale (BPRS) [ Time Frame: Baseline (Day-2 to Day 0) ]
  • Evaluation of psychic tolerance using the Brief Psychiatric Rating Scale (BPRS) [ Time Frame: Day 1 ]
  • Evaluation of psychic tolerance using the Brief Psychiatric Rating Scale (BPRS) [ Time Frame: Day 2 ]
  • Evaluation of psychic tolerance using the Brief Psychiatric Rating Scale (BPRS) [ Time Frame: Day 3 ]
  • Evaluation of psychic tolerance using the Brief Psychiatric Rating Scale (BPRS) [ Time Frame: Day 4 ]
  • Presence/absence of abnormal monitoring values throughout the study: hypertension [ Time Frame: 6 weeks ]
    Any abnormal hypertension, pulse oxymetry or cardiac frequency values observed during the study will be noted.
  • Presence/absence of abnormal monitoring values throughout the study: pulse oxymetry [ Time Frame: 6 weeks ]
    Any abnormal hypertension, pulse oxymetry or cardiac frequency values observed during the study will be noted.
  • Presence/absence of abnormal monitoring values throughout the study: cardiac frequency [ Time Frame: 6 weeks ]
    Any abnormal hypertension, pulse oxymetry or cardiac frequency values observed during the study will be noted.
  • Evaluation of the improvement of the patient's clinical condition using the Clinical Global Impression scale - Improvement (CGI-I) [ Time Frame: Baseline (Day-2 to Day 0) ]
  • Evaluation of the improvement of the patient's clinical condition using the Clinical Global Impression scale - Improvement (CGI-I) [ Time Frame: 40 min after end of 1st perfusion (Day 0) ]
  • Evaluation of the improvement of the patient's clinical condition using the Clinical Global Impression scale - Improvement (CGI-I) [ Time Frame: 120 min after end of 1st perfusion (Day 0) ]
  • Evaluation of the improvement of the patient's clinical condition using the Clinical Global Impression scale - Improvement (CGI-I) [ Time Frame: 4 hours after end of 1st perfusion (Day 0) ]
  • Evaluation of the improvement of the patient's clinical condition using the Clinical Global Impression scale - Improvement (CGI-I) [ Time Frame: Day 1 ]
  • Evaluation of the improvement of the patient's clinical condition using the Clinical Global Impression scale - Improvement (CGI-I) [ Time Frame: Day 2 ]
  • Evaluation of the improvement of the patient's clinical condition using the Clinical Global Impression scale - Improvement (CGI-I) [ Time Frame: 120 min after end of 2nd perfusion (Day 2) ]
  • Evaluation of the improvement of the patient's clinical condition using the Clinical Global Impression scale - Improvement (CGI-I) [ Time Frame: Day 3 ]
  • Evaluation of the improvement of the patient's clinical condition using the Clinical Global Impression scale - Improvement (CGI-I) [ Time Frame: Day 4 ]
  • Evaluation of the improvement of the patient's clinical condition using the Clinical Global Impression scale - Improvement (CGI-I) [ Time Frame: Week 2 ]
  • Evaluation of the improvement of the patient's clinical condition using the Clinical Global Impression scale - Improvement (CGI-I) [ Time Frame: Week 4 ]
  • Evaluation of the improvement of the patient's clinical condition using the Clinical Global Impression scale - Improvement (CGI-I) [ Time Frame: Week 6 ]
  • The BSSI score [ Time Frame: 24 hours after the last perfusion ]
    A suicidal ideation score measured using the BSS (Beck et al. 1979) in its self report questionnaire form ≤ 3 at 24 hours after the second infusion of ketamine or placebo (yes/no). This scale is validated in French (de Man, Balkou & Iglesias 1987); a threshold ≤ 3 separates the resolution of suicidal ideas from their persistence (Holi et al. 2005; DiazGranados et al. 2010)
Original Secondary Outcome Measures  ICMJE
 (submitted: November 20, 2014)
  • The occurrence of a suicide attempt or a completed suicide (yes/no) [ Time Frame: 6 weeks ]
  • Evaluation of the full spectrum of suicidality using the CSSRS [ Time Frame: Baseline (Day-2 to Day 0) ]
  • Evaluation of the full spectrum of suicidality using the CSSRS [ Time Frame: Day 1 ]
  • Evaluation of the full spectrum of suicidality using the CSSRS [ Time Frame: Day 2 ]
  • Evaluation of the full spectrum of suicidality using the CSSRS [ Time Frame: Day 3 ]
  • Evaluation of the full spectrum of suicidality using the CSSRS [ Time Frame: Day 4 ]
  • Evaluation of the full spectrum of suicidality using the CSSRS [ Time Frame: Week 2 ]
  • Evaluation of the full spectrum of suicidality using the CSSRS [ Time Frame: Week 4 ]
  • Evaluation of the full spectrum of suicidality using the CSSRS [ Time Frame: Week 6 ]
  • The BSSI score [ Time Frame: Baseline (Day-2 to Day 0) ]
  • The BSSI score [ Time Frame: 40 min after end of 1st perfusion (Day 0) ]
  • The BSSI score [ Time Frame: 120 min after end of 1st perfusion (Day 0) ]
  • The BSSI score [ Time Frame: 4 hours after end of 1st perfusion (Day 0) ]
  • The BSSI score [ Time Frame: Day 1 ]
  • The BSSI score [ Time Frame: Day 2 ]
  • The BSSI score [ Time Frame: 40 min after end of 2nd perfusion (Day 2) ]
  • The BSSI score [ Time Frame: 120 min after end of 2nd perfusion (Day 2) ]
  • The BSSI score [ Time Frame: 4 hours after end of 2nd perfusion (Day 2) ]
  • The BSSI score [ Time Frame: Day 4 ]
  • The BSSI score [ Time Frame: Week 2 ]
  • The BSSI score [ Time Frame: Week 4 ]
  • The BSSI score [ Time Frame: Week 6 ]
  • Evaluation of physical pain using a visual analog scale of 0 to 10 following a Lickert model [ Time Frame: Baseline (Day-2 to Day 0) ]
  • Evaluation of physical pain using a visual analog scale of 0 to 10 following a Lickert model [ Time Frame: 40 min after end of 1st perfusion (Day 0) ]
  • Evaluation of physical pain using a visual analog scale of 0 to 10 following a Lickert model [ Time Frame: 120 min after end of 1st perfusion (Day 0) ]
  • Evaluation of physical pain using a visual analog scale of 0 to 10 following a Lickert model [ Time Frame: 4 hours after end of 1st perfusion (Day 0) ]
  • Evaluation of physical pain using a visual analog scale of 0 to 10 following a Lickert model [ Time Frame: Day 1 ]
  • Evaluation of physical pain using a visual analog scale of 0 to 10 following a Lickert model [ Time Frame: Day 2 ]
  • Evaluation of physical pain using a visual analog scale of 0 to 10 following a Lickert model [ Time Frame: 40 min after end of 2nd perfusion (Day 2) ]
  • Evaluation of physical pain using a visual analog scale of 0 to 10 following a Lickert model [ Time Frame: 120 min after end of 2nd perfusion (Day 2) ]
  • Evaluation of physical pain using a visual analog scale of 0 to 10 following a Lickert model [ Time Frame: 4 hours after end of 2nd perfusion (Day 2) ]
  • Evaluation of physical pain using a visual analog scale of 0 to 10 following a Lickert model [ Time Frame: Day 3 ]
  • Evaluation of physical pain using a visual analog scale of 0 to 10 following a Lickert model [ Time Frame: Day 4 ]
  • Evaluation of physical pain using a visual analog scale of 0 to 10 following a Lickert model [ Time Frame: Week 2 ]
  • Evaluation of physical pain using a visual analog scale of 0 to 10 following a Lickert model [ Time Frame: Week 4 ]
  • Evaluation of physical pain using a visual analog scale of 0 to 10 following a Lickert model [ Time Frame: Week 6 ]
  • Evaluation of mental pain using a visual analog scale of 0 to 10 following a Lickert model [ Time Frame: Baseline (Day-2 to Day 0) ]
  • Evaluation of mental pain using a visual analog scale of 0 to 10 following a Lickert model [ Time Frame: 40 min after end of 1st perfusion (Day 0) ]
  • Evaluation of mental pain using a visual analog scale of 0 to 10 following a Lickert model [ Time Frame: 120 min after end of 1st perfusion (Day 0) ]
  • Evaluation of mental pain using a visual analog scale of 0 to 10 following a Lickert model [ Time Frame: 4 hours after end of 1st perfusion (Day 0) ]
  • Evaluation of mental pain using a visual analog scale of 0 to 10 following a Lickert model [ Time Frame: Day 1 ]
  • Evaluation of mental pain using a visual analog scale of 0 to 10 following a Lickert model [ Time Frame: Day 2 ]
  • Evaluation of mental pain using a visual analog scale of 0 to 10 following a Lickert model [ Time Frame: 40 min after end of 2nd perfusion (Day 2) ]
  • Evaluation of mental pain using a visual analog scale of 0 to 10 following a Lickert model [ Time Frame: 120 min after end of 2nd perfusion (Day 2) ]
  • Evaluation of mental pain using a visual analog scale of 0 to 10 following a Lickert model [ Time Frame: 4 hours after end of 2nd perfusion (Day 2) ]
  • Evaluation of mental pain using a visual analog scale of 0 to 10 following a Lickert model [ Time Frame: Day 3 ]
  • Evaluation of mental pain using a visual analog scale of 0 to 10 following a Lickert model [ Time Frame: Day 4 ]
  • Evaluation of mental pain using a visual analog scale of 0 to 10 following a Lickert model [ Time Frame: Week 2 ]
  • Evaluation of mental pain using a visual analog scale of 0 to 10 following a Lickert model [ Time Frame: Week 4 ]
  • Evaluation of mental pain using a visual analog scale of 0 to 10 following a Lickert model [ Time Frame: Week 6 ]
  • Evaluation of despair using the Beck Hopelessness Scale [ Time Frame: Baseline (Day-2 to Day 0) ]
  • Evaluation of despair using the Beck Hopelessness Scale [ Time Frame: Day 1 ]
  • Evaluation of despair using the Beck Hopelessness Scale [ Time Frame: Day 2 ]
  • Evaluation of despair using the Beck Hopelessness Scale [ Time Frame: Day 3 ]
  • Evaluation of despair using the Beck Hopelessness Scale [ Time Frame: Day 4 ]
  • Evaluation of despair using the Beck Hopelessness Scale [ Time Frame: Week 2 ]
  • Evaluation of despair using the Beck Hopelessness Scale [ Time Frame: Week 4 ]
  • Evaluation of despair using the Beck Hopelessness Scale [ Time Frame: Week 6 ]
  • Evaluation of depression by the patient (QIDS-SR16) [ Time Frame: Baseline (Day-2 to Day 0) ]
  • Evaluation of depression by the patient (QIDS-SR16) [ Time Frame: 40 min after end of 1st perfusion (Day 0) ]
  • Evaluation of depression by the patient (QIDS-SR16) [ Time Frame: 120 min after end of 1st perfusion (Day 0) ]
  • Evaluation of depression by the patient (QIDS-SR16) [ Time Frame: 40 min after end of 2nd perfusion (Day 2) ]
  • Evaluation of depression by the patient (QIDS-SR16) [ Time Frame: 120 min after end of 2nd perfusion (Day 2) ]
  • Evaluation of depression by the clinician (IDS-C30) [ Time Frame: Baseline (Day-2 to Day 0) ]
  • Evaluation of depression by the clinician (IDS-C30) [ Time Frame: 4 hours after end of 1st perfusion (Day 0) ]
  • Evaluation of depression by the clinician (IDS-C30) [ Time Frame: Day 1 ]
  • Evaluation of depression by the clinician (IDS-C30) [ Time Frame: Day 2 ]
  • Evaluation of depression by the clinician (IDS-C30) [ Time Frame: 4 hours after end of 2nd perfusion (Day 2) ]
  • Evaluation of depression by the clinician (IDS-C30) [ Time Frame: Day 3 ]
  • Evaluation of depression by the clinician (IDS-C30) [ Time Frame: Day 4 ]
  • Evaluation of depression by the clinician (IDS-C30) [ Time Frame: Week 2 ]
  • Evaluation of depression by the clinician (IDS-C30) [ Time Frame: Week 4 ]
  • Evaluation of depression by the clinician (IDS-C30) [ Time Frame: Week 6 ]
  • Evaluation of somatic tolerance of ketamine using the Patient Rated Inventory of Side Effects (PRISE) throughout follow-up [ Time Frame: Baseline (Day-2 to Day 0) ]
  • Evaluation of somatic tolerance of ketamine using the Patient Rated Inventory of Side Effects (PRISE) throughout follow-up [ Time Frame: Day 1 ]
  • Evaluation of somatic tolerance of ketamine using the Patient Rated Inventory of Side Effects (PRISE) throughout follow-up [ Time Frame: Day 2 ]
  • Evaluation of somatic tolerance of ketamine using the Patient Rated Inventory of Side Effects (PRISE) throughout follow-up [ Time Frame: Day 3 ]
  • Evaluation of somatic tolerance of ketamine using the Patient Rated Inventory of Side Effects (PRISE) throughout follow-up [ Time Frame: Day 4 ]
  • Evaluation of psychic tolerance using the Young Mania Rating Scale (YMRS) [ Time Frame: Baseline (Day-2 to Day 0) ]
  • Evaluation of psychic tolerance using the Young Mania Rating Scale (YMRS) [ Time Frame: Day 1 ]
  • Evaluation of psychic tolerance using the Young Mania Rating Scale (YMRS) [ Time Frame: Day 2 ]
  • Evaluation of psychic tolerance using the Young Mania Rating Scale (YMRS) [ Time Frame: Day 3 ]
  • Evaluation of psychic tolerance using the Young Mania Rating Scale (YMRS) [ Time Frame: Day 4 ]
  • Evaluation of psychic tolerance using the Brief Psychiatric Rating Scale (BPRS) [ Time Frame: Baseline (Day-2 to Day 0) ]
  • Evaluation of psychic tolerance using the Brief Psychiatric Rating Scale (BPRS) [ Time Frame: Day 1 ]
  • Evaluation of psychic tolerance using the Brief Psychiatric Rating Scale (BPRS) [ Time Frame: Day 2 ]
  • Evaluation of psychic tolerance using the Brief Psychiatric Rating Scale (BPRS) [ Time Frame: Day 3 ]
  • Evaluation of psychic tolerance using the Brief Psychiatric Rating Scale (BPRS) [ Time Frame: Day 4 ]
  • Presence/absence of abnormal monitoring values throughout the study: hypertension [ Time Frame: 6 weeks ]
    Any abnormal hypertension, pulse oxymetry or cardiac frequency values observed during the study will be noted.
  • Presence/absence of abnormal monitoring values throughout the study: pulse oxymetry [ Time Frame: 6 weeks ]
    Any abnormal hypertension, pulse oxymetry or cardiac frequency values observed during the study will be noted.
  • Presence/absence of abnormal monitoring values throughout the study: cardiac frequency [ Time Frame: 6 weeks ]
    Any abnormal hypertension, pulse oxymetry or cardiac frequency values observed during the study will be noted.
  • Evaluation of the improvement of the patient's clinical condition using the Clinical Global Impression scale - Improvement (CGI-I) [ Time Frame: Baseline (Day-2 to Day 0) ]
  • Evaluation of the improvement of the patient's clinical condition using the Clinical Global Impression scale - Improvement (CGI-I) [ Time Frame: 40 min after end of 1st perfusion (Day 0) ]
  • Evaluation of the improvement of the patient's clinical condition using the Clinical Global Impression scale - Improvement (CGI-I) [ Time Frame: 120 min after end of 1st perfusion (Day 0) ]
  • Evaluation of the improvement of the patient's clinical condition using the Clinical Global Impression scale - Improvement (CGI-I) [ Time Frame: 4 hours after end of 1st perfusion (Day 0) ]
  • Evaluation of the improvement of the patient's clinical condition using the Clinical Global Impression scale - Improvement (CGI-I) [ Time Frame: Day 1 ]
  • Evaluation of the improvement of the patient's clinical condition using the Clinical Global Impression scale - Improvement (CGI-I) [ Time Frame: Day 2 ]
  • Evaluation of the improvement of the patient's clinical condition using the Clinical Global Impression scale - Improvement (CGI-I) [ Time Frame: 40 min after end of 2nd perfusion (Day 2) ]
  • Evaluation of the improvement of the patient's clinical condition using the Clinical Global Impression scale - Improvement (CGI-I) [ Time Frame: 120 min after end of 2nd perfusion (Day 2) ]
  • Evaluation of the improvement of the patient's clinical condition using the Clinical Global Impression scale - Improvement (CGI-I) [ Time Frame: 4 hours after end of 2nd perfusion (Day 2) ]
  • Evaluation of the improvement of the patient's clinical condition using the Clinical Global Impression scale - Improvement (CGI-I) [ Time Frame: Day 3 ]
  • Evaluation of the improvement of the patient's clinical condition using the Clinical Global Impression scale - Improvement (CGI-I) [ Time Frame: Day 4 ]
  • Evaluation of the improvement of the patient's clinical condition using the Clinical Global Impression scale - Improvement (CGI-I) [ Time Frame: Week 2 ]
  • Evaluation of the improvement of the patient's clinical condition using the Clinical Global Impression scale - Improvement (CGI-I) [ Time Frame: Week 4 ]
  • Evaluation of the improvement of the patient's clinical condition using the Clinical Global Impression scale - Improvement (CGI-I) [ Time Frame: Week 6 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effects of Ketamine in the Acute Phase of Suicidal Ideation
Official Title  ICMJE Evaluation of the Effects of Ketamine in the Acute Phase of Suicidal Ideation: a Multicenter Randomized Double-blind Trial
Brief Summary 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.
Detailed Description

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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Suicidal Ideation
Intervention  ICMJE
  • Other: Baseline evaluation
    Before perfusions begin, each patient will have a baseline evaluation including the following: the Columbia Suicide Severity Rating Scale (CSSRS), the Beck Scale for Suicide Ideation (BSSI), a physical pain VAS (visual analog scale), a mental pain VAS, the Clinical Global Impressions Scale (CGI-S), Beck's Hopeless scale (BHS), the Inventory of Depressive Symptomatology for the Clinician (IDS-C30), the Patient Rated Inventory of Side Effects (PRISE), the Young Mania Rating Scale (YMRS) and the Brief Psychiatric Rating Scale (BPRS).
  • Drug: 1st perfusion of ketamine
    A 1st perfusion of ketamine is performed: 0.5 mg/kg diluted in saline, administered over 40 minutes by intravenous (IV) pump and cardiorespiratory monitoring. (Day 0)
  • Drug: 1st perfusion of saline
    A 1st perfusion of saline is performed: the same volume of saline as in the ketamine arm, administered over 40 minutes by IV pump and cardiorespiratory monitoring. (Day 0)
  • Other: Follow-up between perfusions
    Patients will be re-evaluated with a selection of questionnaires at 40 minutes, 120 minutes, 4 hours, and 24 hours after the end of the first perfusion, and then again at 48 hours after the end of the first perfusion and right before the second perfusion and then again Day 3, Day 4, Week 2, Week 4 and Week 6.
  • Drug: 2nd perfusion of ketamine
    A 2nd perfusion of ketamine is performed: 0.5 mg/kg diluted in saline, administered over 40 minutes by intravenous (IV) pump and cardiorespiratory monitoring. (Day 2)
  • Drug: 2nd perfusion of saline
    A 2nd perfusion of saline is performed: the same volume of saline as in the ketamine arm, administered over 40 minutes by IV pump and cardiorespiratory monitoring. (Day 2)
Study Arms  ICMJE
  • Experimental: Ketamine

    Patients randomized to this group will be treated via Ketamine infusion.

    Intervention: Baseline evaluation Intervention: 1st perfusion of ketamine Intervention: Follow-up between perfusions Intervention: 2nd perfusion of ketamine Intervention: Follow-up after perfusions

    Interventions:
    • Other: Baseline evaluation
    • Drug: 1st perfusion of ketamine
    • Other: Follow-up between perfusions
    • Drug: 2nd perfusion of ketamine
  • Placebo Comparator: Placebo/Control

    Patients randomized to this group will be treated via saline solution infusion.

    Intervention: Baseline evaluation Intervention: 1st perfusion of saline Intervention: Follow-up between perfusions Intervention: 2nd perfusion of saline Intervention: Follow-up after perfusions

    Interventions:
    • Other: Baseline evaluation
    • Drug: 1st perfusion of saline
    • Other: Follow-up between perfusions
    • Drug: 2nd perfusion of saline
Publications * Witt KG, Hetrick SE, Rajaram G, Hazell P, Taylor Salisbury TL, Townsend E, Hawton K. Psychosocial interventions for self-harm in adults. Cochrane Database Syst Rev. 2021 Apr 22;4:CD013668. doi: 10.1002/14651858.CD013668.pub2.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 20, 2014)
156
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE March 26, 2019
Actual Primary Completion Date March 12, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • French speaking patients freely hospitalized for prevention of suicide and who have a medium or high suicide risk score according to a MINI structured interview
  • The patient is able to understand how the study is carried out and the tests performed
  • The patient is deemed capable of giving his/her informed consent
  • The patient has been correctly informed
  • The patient must have given his/her informed and signed consent.
  • The patient must be insured or beneficiary of a health insurance plan.
  • Presence of suicidal ideation according to the SSI score (score > 3)
  • Negative pregnancy test for women of childbearing age

Exclusion Criteria:

  • The patient is participating in another interventional study
  • Within the past three months, the patient has participated in another interventional study
  • The patient is in an exclusion period determined by a previous study
  • The patient is under judicial protection
  • The patient is an adult under guardianship
  • The patient refuses to sign the consent
  • The patient is not able to understand the informed consent
  • Pregnancy or breastfeeding
  • History of schizophrenia or other psychotic disorders
  • Presence of psychotic symptoms at initial interview
  • Schizoid or schizotypic personality disorder
  • Positive urine screening for illicit substances, excluding cannabis
  • Substance dependence in the preceding month (excluding nicotine or caffeine)
  • Concomitant treatment with electroconvulsive therapy
  • Unstable somatic pathology
  • Clinically significant anomalies found during clinical examination, biological test or ECG
  • Non-stabilized hypertension or hypertension > 180/100
  • Known or suspected contra-indication for ketamine (includes interactions): hypersensitivity to ketamine, hypertension, class IV cardiac insufficiency, history of stroke, hepatic or cutaneous porphyria, history of intracranial hypertension
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02299440
Other Study ID Numbers  ICMJE PHRC-N/2013/MA-01
2014-001324-30 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Centre Hospitalier Universitaire de Nīmes
Study Sponsor  ICMJE Centre Hospitalier Universitaire de Nīmes
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Mocrane Abbar, MD Centre Hospitalier Universitaire de Nîmes
PRS Account Centre Hospitalier Universitaire de Nīmes
Verification Date March 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP