Effects of Ketamine in the Acute Phase of Suicidal Ideation

NCT02299440 | Completed Phase 3 DMC

• 2 other identifiers: PHRC-N/2013/MA-012014-001324-30
• Study Type: interventional
• Target: 156
• Locations: 1 country
• Sites: 9

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.

Conditions

Suicidal Ideation

Keywords

treatment of acute suicidal ideation; ketamine; low-dose ketamine

Outcome Measures

Primary Outcomes (1)

• 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).

  Day 3

Secondary Outcomes (89)

• The occurrence of a suicide attempt or a completed suicide (yes/no)

  6 weeks

• Evaluation of the full spectrum of suicidality using the CSSRS

  Baseline (Day-2 to Day 0)

• Evaluation of the full spectrum of suicidality using the CSSRS

  Day 1

• Evaluation of the full spectrum of suicidality using the CSSRS

  Day 2

• Evaluation of the full spectrum of suicidality using the CSSRS

  Day 3

Study Arms (2)

Ketamine

EXPERIMENTAL

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

Other: Baseline evaluation; Drug: 1st perfusion of ketamine; Other: Follow-up between perfusions; Drug: 2nd perfusion of ketamine

Placebo/Control

PLACEBO COMPARATOR

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

Other: Baseline evaluation; Drug: 1st perfusion of saline; Other: Follow-up between perfusions; Drug: 2nd perfusion of saline

Interventions

Baseline evaluation OTHER

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).

Ketamine; Placebo/Control

1st perfusion of ketamine DRUG

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)

Ketamine

1st perfusion of saline DRUG

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)

Placebo/Control

Follow-up between perfusions OTHER

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.

Ketamine; Placebo/Control

2nd perfusion of ketamine DRUG

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)

Ketamine

2nd perfusion of saline DRUG

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)

Placebo/Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• The patient is participating in another interventional study
• Within the past three months, the patient has participated in another interventional 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

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Nīmes: lead

Study Sites (9)

CHU de Clermont Ferrand - Hôpital Gabriel-Montpied

Clermont-Ferrand, 63003, France

Location

CHRU de Lille - Hôpital Michel Fontan

Lille, 59037, France

Location

CHRU de Montpellier - Hôpital Lapeyronie

Montpellier, 34295, France

Location

Clinique Les Sophoras

Nîmes, 30000, France

Location

CHRU de Nîmes - Hôpital Universitaire Carémeau

Nîmes, 30029, France

Location

APHP - Hôpital Lariboisière

Paris, 75010, France

Location

Centre Hospitalier Sainte-Anne

Paris, 75674, France

Location

CMME Centre Hospitalier Sainte Anne

Paris, 75674, France

Location

CHRU de Tours - Clinique Psychiatrique Universitaire

Saint-Cyr-sur-Loire, 37540, France

Location

Related Publications (2)

• 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.

  PMID: 35110300 RESULT

• 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.

  PMID: 33884617 DERIVED

MeSH Terms

Conditions

Suicidal Ideation

Condition Hierarchy (Ancestors)

Suicide; Self-Injurious Behavior; Behavioral Symptoms; Behavior

Study Officials

• Mocrane Abbar, MD

  Centre Hospitalier Universitaire de Nîmes

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 20, 2014
• First Posted: November 24, 2014
• Study Start: April 1, 2015
• Primary Completion: November 21, 2019
• Study Completion: November 21, 2019
• Last Updated: December 1, 2025

Record last verified: 2019-03

Data Sharing

• IPD Sharing: Will not share

Locations

FR (9)