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

Primary Purpose

Suicidal Ideation

Status
Completed
Phase
Phase 3
Locations
France
Study Type
Interventional
Intervention
Baseline evaluation
1st perfusion of ketamine
1st perfusion of saline
Follow-up between perfusions
2nd perfusion of ketamine
2nd perfusion of saline
Sponsored by
Centre Hospitalier Universitaire de Nīmes
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Suicidal Ideation focused on measuring treatment of acute suicidal ideation, ketamine, low-dose ketamine

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • CHU de Clermont Ferrand - Hôpital Gabriel-Montpied
  • CHRU de Lille - Hôpital Michel Fontan
  • CHRU de Montpellier - Hôpital Lapeyronie
  • CHRU de Nîmes - Hôpital Universitaire Carémeau
  • Clinique Les Sophoras
  • Centre Hospitalier Sainte-Anne
  • APHP - Hôpital Lariboisière
  • CMME Centre Hospitalier Sainte Anne
  • CHRU de Tours - Clinique Psychiatrique Universitaire

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Ketamine

Placebo/Control

Arm Description

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

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

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

The occurrence of a suicide attempt or a completed suicide (yes/no)
Evaluation of the full spectrum of suicidality using the CSSRS
Evaluation of the full spectrum of suicidality using the CSSRS
Evaluation of the full spectrum of suicidality using the CSSRS
Evaluation of the full spectrum of suicidality using the CSSRS
Evaluation of the full spectrum of suicidality using the CSSRS
Evaluation of the full spectrum of suicidality using the CSSRS
Evaluation of the full spectrum of suicidality using the CSSRS
Evaluation of the full spectrum of suicidality using the CSSRS
The BSSI score
The BSSI score
The BSSI score
The BSSI score
The BSSI score
The BSSI score
The BSSI score
The BSSI score
The BSSI score
The BSSI score
Evaluation of physical pain using a visual analog scale of 0 to 10 following a Lickert model
Evaluation of physical pain using a visual analog scale of 0 to 10 following a Lickert model
Evaluation of physical pain using a visual analog scale of 0 to 10 following a Lickert model
Evaluation of physical pain using a visual analog scale of 0 to 10 following a Lickert model
Evaluation of physical pain using a visual analog scale of 0 to 10 following a Lickert model
Evaluation of physical pain using a visual analog scale of 0 to 10 following a Lickert model
Evaluation of physical pain using a visual analog scale of 0 to 10 following a Lickert model
Evaluation of physical pain using a visual analog scale of 0 to 10 following a Lickert model
Evaluation of physical pain using a visual analog scale of 0 to 10 following a Lickert model
Evaluation of physical pain using a visual analog scale of 0 to 10 following a Lickert model
Evaluation of physical pain using a visual analog scale of 0 to 10 following a Lickert model
Evaluation of mental pain using a visual analog scale of 0 to 10 following a Lickert model
Evaluation of mental pain using a visual analog scale of 0 to 10 following a Lickert model
Evaluation of mental pain using a visual analog scale of 0 to 10 following a Lickert model
Evaluation of mental pain using a visual analog scale of 0 to 10 following a Lickert model
Evaluation of mental pain using a visual analog scale of 0 to 10 following a Lickert model
Evaluation of mental pain using a visual analog scale of 0 to 10 following a Lickert model
Evaluation of mental pain using a visual analog scale of 0 to 10 following a Lickert model
Evaluation of mental pain using a visual analog scale of 0 to 10 following a Lickert model
Evaluation of mental pain using a visual analog scale of 0 to 10 following a Lickert model
Evaluation of mental pain using a visual analog scale of 0 to 10 following a Lickert model
Evaluation of mental pain using a visual analog scale of 0 to 10 following a Lickert model
Evaluation of despair using the Beck Hopelessness Scale
Evaluation of despair using the Beck Hopelessness Scale
Evaluation of despair using the Beck Hopelessness Scale
Evaluation of despair using the Beck Hopelessness Scale
Evaluation of despair using the Beck Hopelessness Scale
Evaluation of despair using the Beck Hopelessness Scale
Evaluation of despair using the Beck Hopelessness Scale
Evaluation of despair using the Beck Hopelessness Scale
Evaluation of depression by the clinician (IDS-C30)
Evaluation of depression by the clinician (IDS-C30)
Evaluation of depression by the clinician (IDS-C30)
Evaluation of depression by the clinician (IDS-C30)
Evaluation of depression by the clinician (IDS-C30)
Evaluation of depression by the clinician (IDS-C30)
Evaluation of depression by the clinician (IDS-C30)
Evaluation of depression by the clinician (IDS-C30)
Evaluation of depression by the clinician (IDS-C30)
Evaluation of somatic tolerance of ketamine using the Patient Rated Inventory of Side Effects (PRISE) throughout follow-up
Evaluation of somatic tolerance of ketamine using the Patient Rated Inventory of Side Effects (PRISE) throughout follow-up
Evaluation of somatic tolerance of ketamine using the Patient Rated Inventory of Side Effects (PRISE) throughout follow-up
Evaluation of somatic tolerance of ketamine using the Patient Rated Inventory of Side Effects (PRISE) throughout follow-up
Evaluation of somatic tolerance of ketamine using the Patient Rated Inventory of Side Effects (PRISE) throughout follow-up
Evaluation of psychic tolerance using the Young Mania Rating Scale (YMRS)
Evaluation of psychic tolerance using the Young Mania Rating Scale (YMRS)
Evaluation of psychic tolerance using the Young Mania Rating Scale (YMRS)
Evaluation of psychic tolerance using the Young Mania Rating Scale (YMRS)
Evaluation of psychic tolerance using the Young Mania Rating Scale (YMRS)
Evaluation of psychic tolerance using the Brief Psychiatric Rating Scale (BPRS)
Evaluation of psychic tolerance using the Brief Psychiatric Rating Scale (BPRS)
Evaluation of psychic tolerance using the Brief Psychiatric Rating Scale (BPRS)
Evaluation of psychic tolerance using the Brief Psychiatric Rating Scale (BPRS)
Evaluation of psychic tolerance using the Brief Psychiatric Rating Scale (BPRS)
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.
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.
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.
Evaluation of the improvement of the patient's clinical condition using the Clinical Global Impression scale - Improvement (CGI-I)
Evaluation of the improvement of the patient's clinical condition using the Clinical Global Impression scale - Improvement (CGI-I)
Evaluation of the improvement of the patient's clinical condition using the Clinical Global Impression scale - Improvement (CGI-I)
Evaluation of the improvement of the patient's clinical condition using the Clinical Global Impression scale - Improvement (CGI-I)
Evaluation of the improvement of the patient's clinical condition using the Clinical Global Impression scale - Improvement (CGI-I)
Evaluation of the improvement of the patient's clinical condition using the Clinical Global Impression scale - Improvement (CGI-I)
Evaluation of the improvement of the patient's clinical condition using the Clinical Global Impression scale - Improvement (CGI-I)
Evaluation of the improvement of the patient's clinical condition using the Clinical Global Impression scale - Improvement (CGI-I)
Evaluation of the improvement of the patient's clinical condition using the Clinical Global Impression scale - Improvement (CGI-I)
Evaluation of the improvement of the patient's clinical condition using the Clinical Global Impression scale - Improvement (CGI-I)
Evaluation of the improvement of the patient's clinical condition using the Clinical Global Impression scale - Improvement (CGI-I)
Evaluation of the improvement of the patient's clinical condition using the Clinical Global Impression scale - Improvement (CGI-I)
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)

Full Information

First Posted
November 20, 2014
Last Updated
May 27, 2019
Sponsor
Centre Hospitalier Universitaire de Nīmes
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1. Study Identification

Unique Protocol Identification Number
NCT02299440
Brief Title
Effects of Ketamine in the Acute Phase of Suicidal Ideation
Acronym
KETIS
Official Title
Evaluation of the Effects of Ketamine in the Acute Phase of Suicidal Ideation: a Multicenter Randomized Double-blind Trial
Study Type
Interventional

2. Study Status

Record Verification Date
March 2019
Overall Recruitment Status
Completed
Study Start Date
April 2015 (Actual)
Primary Completion Date
March 12, 2019 (Actual)
Study Completion Date
March 26, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire de Nīmes

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Suicidal Ideation
Keywords
treatment of acute suicidal ideation, ketamine, low-dose ketamine

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
156 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Ketamine
Arm Type
Experimental
Arm Description
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
Arm Title
Placebo/Control
Arm Type
Placebo Comparator
Arm Description
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
Intervention Type
Other
Intervention Name(s)
Baseline evaluation
Intervention Description
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).
Intervention Type
Drug
Intervention Name(s)
1st perfusion of ketamine
Intervention Description
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)
Intervention Type
Drug
Intervention Name(s)
1st perfusion of saline
Intervention Description
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)
Intervention Type
Other
Intervention Name(s)
Follow-up between perfusions
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
2nd perfusion of ketamine
Intervention Description
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)
Intervention Type
Drug
Intervention Name(s)
2nd perfusion of saline
Intervention Description
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)
Primary Outcome Measure Information:
Title
BSSI score
Description
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
Secondary Outcome Measure Information:
Title
The occurrence of a suicide attempt or a completed suicide (yes/no)
Time Frame
6 weeks
Title
Evaluation of the full spectrum of suicidality using the CSSRS
Time Frame
Baseline (Day-2 to Day 0)
Title
Evaluation of the full spectrum of suicidality using the CSSRS
Time Frame
Day 1
Title
Evaluation of the full spectrum of suicidality using the CSSRS
Time Frame
Day 2
Title
Evaluation of the full spectrum of suicidality using the CSSRS
Time Frame
Day 3
Title
Evaluation of the full spectrum of suicidality using the CSSRS
Time Frame
Day 4
Title
Evaluation of the full spectrum of suicidality using the CSSRS
Time Frame
Week 2
Title
Evaluation of the full spectrum of suicidality using the CSSRS
Time Frame
Week 4
Title
Evaluation of the full spectrum of suicidality using the CSSRS
Time Frame
Week 6
Title
The BSSI score
Time Frame
Baseline (Day-2 to Day 0)
Title
The BSSI score
Time Frame
40 min after end of 1st perfusion (Day 0)
Title
The BSSI score
Time Frame
120 min after end of 1st perfusion (Day 0)
Title
The BSSI score
Time Frame
4 hours after end of 1st perfusion (Day 0)
Title
The BSSI score
Time Frame
Day 1
Title
The BSSI score
Time Frame
Day 2
Title
The BSSI score
Time Frame
Day 4
Title
The BSSI score
Time Frame
Week 2
Title
The BSSI score
Time Frame
Week 4
Title
The BSSI score
Time Frame
Week 6
Title
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)
Title
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)
Title
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)
Title
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)
Title
Evaluation of physical pain using a visual analog scale of 0 to 10 following a Lickert model
Time Frame
Day 1
Title
Evaluation of physical pain using a visual analog scale of 0 to 10 following a Lickert model
Time Frame
Day 2
Title
Evaluation of physical pain using a visual analog scale of 0 to 10 following a Lickert model
Time Frame
Day 3
Title
Evaluation of physical pain using a visual analog scale of 0 to 10 following a Lickert model
Time Frame
Day 4
Title
Evaluation of physical pain using a visual analog scale of 0 to 10 following a Lickert model
Time Frame
Week 2
Title
Evaluation of physical pain using a visual analog scale of 0 to 10 following a Lickert model
Time Frame
Week 4
Title
Evaluation of physical pain using a visual analog scale of 0 to 10 following a Lickert model
Time Frame
Week 6
Title
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)
Title
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)
Title
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)
Title
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)
Title
Evaluation of mental pain using a visual analog scale of 0 to 10 following a Lickert model
Time Frame
Day 1
Title
Evaluation of mental pain using a visual analog scale of 0 to 10 following a Lickert model
Time Frame
Day 2
Title
Evaluation of mental pain using a visual analog scale of 0 to 10 following a Lickert model
Time Frame
Day 3
Title
Evaluation of mental pain using a visual analog scale of 0 to 10 following a Lickert model
Time Frame
Day 4
Title
Evaluation of mental pain using a visual analog scale of 0 to 10 following a Lickert model
Time Frame
Week 2
Title
Evaluation of mental pain using a visual analog scale of 0 to 10 following a Lickert model
Time Frame
Week 4
Title
Evaluation of mental pain using a visual analog scale of 0 to 10 following a Lickert model
Time Frame
Week 6
Title
Evaluation of despair using the Beck Hopelessness Scale
Time Frame
Baseline (Day-2 to Day 0)
Title
Evaluation of despair using the Beck Hopelessness Scale
Time Frame
Day 1
Title
Evaluation of despair using the Beck Hopelessness Scale
Time Frame
Day 2
Title
Evaluation of despair using the Beck Hopelessness Scale
Time Frame
Day 3
Title
Evaluation of despair using the Beck Hopelessness Scale
Time Frame
Day 4
Title
Evaluation of despair using the Beck Hopelessness Scale
Time Frame
Week 2
Title
Evaluation of despair using the Beck Hopelessness Scale
Time Frame
Week 4
Title
Evaluation of despair using the Beck Hopelessness Scale
Time Frame
Week 6
Title
Evaluation of depression by the clinician (IDS-C30)
Time Frame
Baseline (Day-2 to Day 0)
Title
Evaluation of depression by the clinician (IDS-C30)
Time Frame
4 hours after end of 1st perfusion (Day 0)
Title
Evaluation of depression by the clinician (IDS-C30)
Time Frame
Day 1
Title
Evaluation of depression by the clinician (IDS-C30)
Time Frame
Day 2
Title
Evaluation of depression by the clinician (IDS-C30)
Time Frame
Day 3
Title
Evaluation of depression by the clinician (IDS-C30)
Time Frame
Day 4
Title
Evaluation of depression by the clinician (IDS-C30)
Time Frame
Week 2
Title
Evaluation of depression by the clinician (IDS-C30)
Time Frame
Week 4
Title
Evaluation of depression by the clinician (IDS-C30)
Time Frame
Week 6
Title
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)
Title
Evaluation of somatic tolerance of ketamine using the Patient Rated Inventory of Side Effects (PRISE) throughout follow-up
Time Frame
Day 1
Title
Evaluation of somatic tolerance of ketamine using the Patient Rated Inventory of Side Effects (PRISE) throughout follow-up
Time Frame
Day 2
Title
Evaluation of somatic tolerance of ketamine using the Patient Rated Inventory of Side Effects (PRISE) throughout follow-up
Time Frame
Day 3
Title
Evaluation of somatic tolerance of ketamine using the Patient Rated Inventory of Side Effects (PRISE) throughout follow-up
Time Frame
Day 4
Title
Evaluation of psychic tolerance using the Young Mania Rating Scale (YMRS)
Time Frame
Baseline (Day-2 to Day 0)
Title
Evaluation of psychic tolerance using the Young Mania Rating Scale (YMRS)
Time Frame
Day 1
Title
Evaluation of psychic tolerance using the Young Mania Rating Scale (YMRS)
Time Frame
Day 2
Title
Evaluation of psychic tolerance using the Young Mania Rating Scale (YMRS)
Time Frame
Day 3
Title
Evaluation of psychic tolerance using the Young Mania Rating Scale (YMRS)
Time Frame
Day 4
Title
Evaluation of psychic tolerance using the Brief Psychiatric Rating Scale (BPRS)
Time Frame
Baseline (Day-2 to Day 0)
Title
Evaluation of psychic tolerance using the Brief Psychiatric Rating Scale (BPRS)
Time Frame
Day 1
Title
Evaluation of psychic tolerance using the Brief Psychiatric Rating Scale (BPRS)
Time Frame
Day 2
Title
Evaluation of psychic tolerance using the Brief Psychiatric Rating Scale (BPRS)
Time Frame
Day 3
Title
Evaluation of psychic tolerance using the Brief Psychiatric Rating Scale (BPRS)
Time Frame
Day 4
Title
Presence/absence of abnormal monitoring values throughout the study: hypertension
Description
Any abnormal hypertension, pulse oxymetry or cardiac frequency values observed during the study will be noted.
Time Frame
6 weeks
Title
Presence/absence of abnormal monitoring values throughout the study: pulse oxymetry
Description
Any abnormal hypertension, pulse oxymetry or cardiac frequency values observed during the study will be noted.
Time Frame
6 weeks
Title
Presence/absence of abnormal monitoring values throughout the study: cardiac frequency
Description
Any abnormal hypertension, pulse oxymetry or cardiac frequency values observed during the study will be noted.
Time Frame
6 weeks
Title
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)
Title
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)
Title
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)
Title
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)
Title
Evaluation of the improvement of the patient's clinical condition using the Clinical Global Impression scale - Improvement (CGI-I)
Time Frame
Day 1
Title
Evaluation of the improvement of the patient's clinical condition using the Clinical Global Impression scale - Improvement (CGI-I)
Time Frame
Day 2
Title
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)
Title
Evaluation of the improvement of the patient's clinical condition using the Clinical Global Impression scale - Improvement (CGI-I)
Time Frame
Day 3
Title
Evaluation of the improvement of the patient's clinical condition using the Clinical Global Impression scale - Improvement (CGI-I)
Time Frame
Day 4
Title
Evaluation of the improvement of the patient's clinical condition using the Clinical Global Impression scale - Improvement (CGI-I)
Time Frame
Week 2
Title
Evaluation of the improvement of the patient's clinical condition using the Clinical Global Impression scale - Improvement (CGI-I)
Time Frame
Week 4
Title
Evaluation of the improvement of the patient's clinical condition using the Clinical Global Impression scale - Improvement (CGI-I)
Time Frame
Week 6
Title
The BSSI score
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mocrane Abbar, MD
Organizational Affiliation
Centre Hospitalier Universitaire de Nîmes
Official's Role
Study Director
Facility Information:
Facility Name
CHU de Clermont Ferrand - Hôpital Gabriel-Montpied
City
Clermont Ferrand
ZIP/Postal Code
63003
Country
France
Facility Name
CHRU de Lille - Hôpital Michel Fontan
City
Lille
ZIP/Postal Code
59037
Country
France
Facility Name
CHRU de Montpellier - Hôpital Lapeyronie
City
Montpellier
ZIP/Postal Code
34295
Country
France
Facility Name
CHRU de Nîmes - Hôpital Universitaire Carémeau
City
Nîmes Cedex 09
ZIP/Postal Code
30029
Country
France
Facility Name
Clinique Les Sophoras
City
Nîmes
ZIP/Postal Code
30000
Country
France
Facility Name
Centre Hospitalier Sainte-Anne
City
Paris cedex 14
ZIP/Postal Code
75674
Country
France
Facility Name
APHP - Hôpital Lariboisière
City
Paris
ZIP/Postal Code
75010
Country
France
Facility Name
CMME Centre Hospitalier Sainte Anne
City
Paris
ZIP/Postal Code
75674
Country
France
Facility Name
CHRU de Tours - Clinique Psychiatrique Universitaire
City
Saint Cyr sur Loire
ZIP/Postal Code
37540
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
35110300
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.
Results Reference
derived
PubMed Identifier
33884617
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.
Results Reference
derived

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Effects of Ketamine in the Acute Phase of Suicidal Ideation

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