Clinical trial NCT02299440: Effects of Ketamine in the Acute Phase of Suicidal Ideation
Official title: Evaluation of the Effects of Ketamine in the Acute Phase of Suicidal Ideation: a Multicenter Randomized Double-blind Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Suicidal Ideation
Keywords: treatment of acute suicidal ideation
ketamine
low-dose ketamine
Lead sponsor: Centre Hospitalier Universitaire de Nīmes
Sponsor class: OTHER
First posted: 2014-11-24
Enrollment: 156
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: BSSI score
timeFrame: Day 3
Secondary outcomes:
measure: The occurrence of a suicide attempt or a completed suicide (yes/no)
timeFrame: 6 weeks
measure: Evaluation of the full spectrum of suicidality using the CSSRS
timeFrame: Baseline (Day-2 to Day 0)
measure: Evaluation of the full spectrum of suicidality using the CSSRS
timeFrame: Day 1
measure: Evaluation of the full spectrum of suicidality using the CSSRS
timeFrame: Day 2
measure: Evaluation of the full spectrum of suicidality using the CSSRS
timeFrame: Day 3
measure: Evaluation of the full spectrum of suicidality using the CSSRS
timeFrame: Day 4
measure: Evaluation of the full spectrum of suicidality using the CSSRS
timeFrame: Week 2
measure: Evaluation of the full spectrum of suicidality using the CSSRS
timeFrame: Week 4
measure: Evaluation of the full spectrum of suicidality using the CSSRS
timeFrame: Week 6
measure: The BSSI score
timeFrame: Baseline (Day-2 to Day 0)
measure: The BSSI score
timeFrame: 40 min after end of 1st perfusion (Day 0)
measure: The BSSI score
timeFrame: 120 min after end of 1st perfusion (Day 0)
measure: The BSSI score
timeFrame: 4 hours after end of 1st perfusion (Day 0)
measure: The BSSI score
timeFrame: Day 1
measure: The BSSI score
timeFrame: Day 2
measure: The BSSI score
timeFrame: Day 4
measure: The BSSI score
timeFrame: Week 2
measure: The BSSI score
timeFrame: Week 4
measure: The BSSI score
timeFrame: Week 6
measure: Evaluation of physical pain using a visual analog scale of 0 to 10 following a Lickert model
timeFrame: Baseline (Day-2 to Day 0)
measure: Evaluation of physical pain using a visual analog scale of 0 to 10 following a Lickert model
timeFrame: 40 min after end of 1st perfusion (Day 0)
measure: Evaluation of physical pain using a visual analog scale of 0 to 10 following a Lickert model
timeFrame: 120 min after end of 1st perfusion (Day 0)
measure: Evaluation of physical pain using a visual analog scale of 0 to 10 following a Lickert model
timeFrame: 4 hours after end of 1st perfusion (Day 0)
measure: Evaluation of physical pain using a visual analog scale of 0 to 10 following a Lickert model
timeFrame: Day 1
measure: Evaluation of physical pain using a visual analog scale of 0 to 10 following a Lickert model
timeFrame: Day 2
measure: Evaluation of physical pain using a visual analog scale of 0 to 10 following a Lickert model
timeFrame: Day 3
measure: Evaluation of physical pain using a visual analog scale of 0 to 10 following a Lickert model
timeFrame: Day 4
measure: Evaluation of physical pain using a visual analog scale of 0 to 10 following a Lickert model
timeFrame: Week 2
measure: Evaluation of physical pain using a visual analog scale of 0 to 10 following a Lickert model
timeFrame: Week 4
measure: Evaluation of physical pain using a visual analog scale of 0 to 10 following a Lickert model
timeFrame: Week 6
measure: Evaluation of mental pain using a visual analog scale of 0 to 10 following a Lickert model
timeFrame: Baseline (Day-2 to Day 0)
measure: Evaluation of mental pain using a visual analog scale of 0 to 10 following a Lickert model
timeFrame: 40 min after end of 1st perfusion (Day 0)
measure: Evaluation of mental pain using a visual analog scale of 0 to 10 following a Lickert model
timeFrame: 120 min after end of 1st perfusion (Day 0)
measure: Evaluation of mental pain using a visual analog scale of 0 to 10 following a Lickert model
timeFrame: 4 hours after end of 1st perfusion (Day 0)
measure: Evaluation of mental pain using a visual analog scale of 0 to 10 following a Lickert model
timeFrame: Day 1
measure: Evaluation of mental pain using a visual analog scale of 0 to 10 following a Lickert model
timeFrame: Day 2
measure: Evaluation of mental pain using a visual analog scale of 0 to 10 following a Lickert model
timeFrame: Day 3
measure: Evaluation of mental pain using a visual analog scale of 0 to 10 following a Lickert model
timeFrame: Day 4
measure: Evaluation of mental pain using a visual analog scale of 0 to 10 following a Lickert model
timeFrame: Week 2
measure: Evaluation of mental pain using a visual analog scale of 0 to 10 following a Lickert model
timeFrame: Week 4
measure: Evaluation of mental pain using a visual analog scale of 0 to 10 following a Lickert model
timeFrame: Week 6
measure: Evaluation of despair using the Beck Hopelessness Scale
timeFrame: Baseline (Day-2 to Day 0)
measure: Evaluation of despair using the Beck Hopelessness Scale
timeFrame: Day 1
measure: Evaluation of despair using the Beck Hopelessness Scale
timeFrame: Day 2
measure: Evaluation of despair using the Beck Hopelessness Scale
timeFrame: Day 3
measure: Evaluation of despair using the Beck Hopelessness Scale
timeFrame: Day 4
measure: Evaluation of despair using the Beck Hopelessness Scale
timeFrame: Week 2
measure: Evaluation of despair using the Beck Hopelessness Scale
timeFrame: Week 4
measure: Evaluation of despair using the Beck Hopelessness Scale
timeFrame: Week 6
measure: Evaluation of depression by the clinician (IDS-C30)
timeFrame: Baseline (Day-2 to Day 0)
measure: Evaluation of depression by the clinician (IDS-C30)
timeFrame: 4 hours after end of 1st perfusion (Day 0)
measure: Evaluation of depression by the clinician (IDS-C30)
timeFrame: Day 1
measure: Evaluation of depression by the clinician (IDS-C30)
timeFrame: Day 2
measure: Evaluation of depression by the clinician (IDS-C30)
timeFrame: Day 3
measure: Evaluation of depression by the clinician (IDS-C30)
timeFrame: Day 4
measure: Evaluation of depression by the clinician (IDS-C30)
timeFrame: Week 2
measure: Evaluation of depression by the clinician (IDS-C30)
timeFrame: Week 4
measure: Evaluation of depression by the clinician (IDS-C30)
timeFrame: Week 6
measure: Evaluation of somatic tolerance of ketamine using the Patient Rated Inventory of Side Effects (PRISE) throughout follow-up
timeFrame: Baseline (Day-2 to Day 0)
measure: Evaluation of somatic tolerance of ketamine using the Patient Rated Inventory of Side Effects (PRISE) throughout follow-up
timeFrame: Day 1
measure: Evaluation of somatic tolerance of ketamine using the Patient Rated Inventory of Side Effects (PRISE) throughout follow-up
timeFrame: Day 2
measure: Evaluation of somatic tolerance of ketamine using the Patient Rated Inventory of Side Effects (PRISE) throughout follow-up
timeFrame: Day 3
measure: Evaluation of somatic tolerance of ketamine using the Patient Rated Inventory of Side Effects (PRISE) throughout follow-up
timeFrame: Day 4
measure: Evaluation of psychic tolerance using the Young Mania Rating Scale (YMRS)
timeFrame: Baseline (Day-2 to Day 0)
measure: Evaluation of psychic tolerance using the Young Mania Rating Scale (YMRS)
timeFrame: Day 1
measure: Evaluation of psychic tolerance using the Young Mania Rating Scale (YMRS)
timeFrame: Day 2
measure: Evaluation of psychic tolerance using the Young Mania Rating Scale (YMRS)
timeFrame: Day 3
measure: Evaluation of psychic tolerance using the Young Mania Rating Scale (YMRS)
timeFrame: Day 4
measure: Evaluation of psychic tolerance using the Brief Psychiatric Rating Scale (BPRS)
timeFrame: Baseline (Day-2 to Day 0)
measure: Evaluation of psychic tolerance using the Brief Psychiatric Rating Scale (BPRS)
timeFrame: Day 1
measure: Evaluation of psychic tolerance using the Brief Psychiatric Rating Scale (BPRS)
timeFrame: Day 2
measure: Evaluation of psychic tolerance using the Brief Psychiatric Rating Scale (BPRS)
timeFrame: Day 3
measure: Evaluation of psychic tolerance using the Brief Psychiatric Rating Scale (BPRS)
timeFrame: Day 4
measure: Presence/absence of abnormal monitoring values throughout the study: hypertension
timeFrame: 6 weeks
measure: Presence/absence of abnormal monitoring values throughout the study: pulse oxymetry
timeFrame: 6 weeks
measure: Presence/absence of abnormal monitoring values throughout the study: cardiac frequency
timeFrame: 6 weeks
measure: Evaluation of the improvement of the patient's clinical condition using the Clinical Global Impression scale - Improvement (CGI-I)
timeFrame: Baseline (Day-2 to Day 0)
measure: Evaluation of the improvement of the patient's clinical condition using the Clinical Global Impression scale - Improvement (CGI-I)
timeFrame: 40 min after end of 1st perfusion (Day 0)
measure: Evaluation of the improvement of the patient's clinical condition using the Clinical Global Impression scale - Improvement (CGI-I)
timeFrame: 120 min after end of 1st perfusion (Day 0)
measure: Evaluation of the improvement of the patient's clinical condition using the Clinical Global Impression scale - Improvement (CGI-I)
timeFrame: 4 hours after end of 1st perfusion (Day 0)
measure: Evaluation of the improvement of the patient's clinical condition using the Clinical Global Impression scale - Improvement (CGI-I)
timeFrame: Day 1
measure: Evaluation of the improvement of the patient's clinical condition using the Clinical Global Impression scale - Improvement (CGI-I)
timeFrame: Day 2
measure: Evaluation of the improvement of the patient's clinical condition using the Clinical Global Impression scale - Improvement (CGI-I)
timeFrame: 120 min after end of 2nd perfusion (Day 2)
measure: Evaluation of the improvement of the patient's clinical condition using the Clinical Global Impression scale - Improvement (CGI-I)
timeFrame: Day 3
measure: Evaluation of the improvement of the patient's clinical condition using the Clinical Global Impression scale - Improvement (CGI-I)
timeFrame: Day 4
measure: Evaluation of the improvement of the patient's clinical condition using the Clinical Global Impression scale - Improvement (CGI-I)
timeFrame: Week 2
measure: Evaluation of the improvement of the patient's clinical condition using the Clinical Global Impression scale - Improvement (CGI-I)
timeFrame: Week 4
measure: Evaluation of the improvement of the patient's clinical condition using the Clinical Global Impression scale - Improvement (CGI-I)
timeFrame: Week 6
measure: The BSSI score
timeFrame: 24 hours after the last perfusion
Other outcomes:
Locations:
city: Clermont Ferrand
country: France
facility: CHU de Clermont Ferrand - Hôpital Gabriel-Montpied
city: Lille
country: France
facility: CHRU de Lille - Hôpital Michel Fontan
city: Montpellier
country: France
facility: CHRU de Montpellier - Hôpital Lapeyronie
city: Nîmes Cedex 09
country: France
facility: CHRU de Nîmes - Hôpital Universitaire Carémeau
city: Nîmes
country: France
facility: Clinique Les Sophoras
city: Paris cedex 14
country: France
facility: Centre Hospitalier Sainte-Anne
city: Paris
country: France
facility: APHP - Hôpital Lariboisière
city: Paris
country: France
facility: CMME Centre Hospitalier Sainte Anne
city: Saint Cyr sur Loire
country: France
facility: CHRU de Tours - Clinique Psychiatrique Universitaire
Study officials:
affiliation: Centre Hospitalier Universitaire de Nîmes
name: Mocrane Abbar, MD
role: STUDY_DIRECTOR
References:
citation: Abbar M, Demattei C, El-Hage W, Llorca PM, Samalin L, Demaricourt P, Gaillard R, Courtet P, Vaiva G, Gorwood P, Fabbro P, Jollant F. Ketamine for the acute treatment of severe suicidal ideation: double blind, randomised placebo controlled trial. BMJ. 2022 Feb 2;376:e067194. doi: 10.1136/bmj-2021-067194.
citation: 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(4):CD013668. doi: 10.1002/14651858.CD013668.pub2.