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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
156
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).
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)
CHU de Clermont Ferrand - Hôpital Gabriel-Montpied
Clermont-Ferrand, France
CHRU de Lille - Hôpital Michel Fontan
Lille, France
CHRU de Montpellier - Hôpital Lapeyronie
Montpellier, France
Clinique Les Sophoras
Nîmes, France
BSSI score
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).
Time frame: Day 3
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
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
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)
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.
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)
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)
CHRU de Nîmes - Hôpital Universitaire Carémeau
Nîmes, France
APHP - Hôpital Lariboisière
Paris, France
Centre Hospitalier Sainte-Anne
Paris, France
CMME Centre Hospitalier Sainte Anne
Paris, France
CHRU de Tours - Clinique Psychiatrique Universitaire
Saint-Cyr-sur-Loire, France
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
Any abnormal hypertension, pulse oxymetry or cardiac frequency values observed during the study will be noted.
Time frame: 6 weeks
Presence/absence of abnormal monitoring values throughout the study: pulse oxymetry
Any abnormal hypertension, pulse oxymetry or cardiac frequency values observed during the study will be noted.
Time frame: 6 weeks
Presence/absence of abnormal monitoring values throughout the study: cardiac frequency
Any abnormal hypertension, pulse oxymetry or cardiac frequency values observed during the study will be noted.
Time frame: 6 weeks
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
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)
Time frame: 24 hours after the last perfusion