Effects of Ketamine in the Acute Phase of Suicidal Ideation

Phase 3

Completed

• Conditions: Suicidal Ideation
• Interventions: Other: Baseline evaluation; Drug: 1st perfusion of ketamine; Drug: 1st perfusion of saline; Other: Follow-up between perfusions; Drug: 2nd perfusion of ketamine; Drug: 2nd perfusion of saline

• Registration Number: NCT02299440
• Lead Sponsor: Centre Hospitalier Universitaire de Nīmes

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 Timeline

• Study First Submitted: 2014-11-20
• Study First Submitted QC: 2014-11-20
• Study First Posted: 2014-11-24
• Study Start: 2015-04
• Status Verified: 2019-03
• Primary Completion: 2019-03-12
• Study Completion: 2019-03-26
• Last Update Submitted: 2019-05-27
• Last Update Posted: 2019-05-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 156

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ketamine	Baseline evaluation	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
Ketamine	1st perfusion of 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
Ketamine	Follow-up between perfusions	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
Ketamine	2nd perfusion of 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
Placebo/Control	Baseline evaluation	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
Placebo/Control	1st perfusion of saline	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
Placebo/Control	Follow-up between 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
Placebo/Control	2nd perfusion of saline	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

Primary Outcome Measures

Name	Time	Method
BSSI score	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).

Secondary Outcome Measures

Name	Time	Method
The BSSI score	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)
Evaluation of physical pain using a visual analog scale of 0 to 10 following a Lickert model	Week 6
Evaluation of mental pain using a visual analog scale of 0 to 10 following a Lickert model	Week 6
The occurrence of a suicide attempt or a completed suicide (yes/no)	6 weeks
Evaluation of the full spectrum of suicidality using the CSSRS	Week 6
Evaluation of despair using the Beck Hopelessness Scale	Week 6
Evaluation of depression by the clinician (IDS-C30)	Week 6
Evaluation of somatic tolerance of ketamine using the Patient Rated Inventory of Side Effects (PRISE) throughout follow-up	Day 4
Evaluation of psychic tolerance using the Young Mania Rating Scale (YMRS)	Day 4
Presence/absence of abnormal monitoring values throughout the study: cardiac frequency	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)	Week 6
Evaluation of psychic tolerance using the Brief Psychiatric Rating Scale (BPRS)	Day 4
Presence/absence of abnormal monitoring values throughout the study: hypertension	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	6 weeks	Any abnormal hypertension, pulse oxymetry or cardiac frequency values observed during the study will be noted.

Trial Locations

Locations (9)

CHRU de Montpellier - Hôpital Lapeyronie; 🇫🇷 Montpellier, France

CHRU de Nîmes - Hôpital Universitaire Carémeau; 🇫🇷 Nîmes Cedex 09, France

Clinique Les Sophoras; 🇫🇷 Nîmes, France

CHRU de Lille - Hôpital Michel Fontan; 🇫🇷 Lille, France

CHU de Clermont Ferrand - Hôpital Gabriel-Montpied; 🇫🇷 Clermont Ferrand, France

Centre Hospitalier Sainte-Anne; 🇫🇷 Paris cedex 14, France

APHP - Hôpital Lariboisière; 🇫🇷 Paris, France

CMME Centre Hospitalier Sainte Anne; 🇫🇷 Paris, France

CHRU de Tours - Clinique Psychiatrique Universitaire; 🇫🇷 Saint Cyr sur Loire, France