NCT02299440

Effects of Ketamine in the Acute Phase of Suicidal Ideation

Evaluation of the Effects of Ketamine in the Acute Phase of Suicidal Ideation: a Multicenter Randomized Double-blind Trial

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 156 (actual)
• Sponsor: Centre Hospitalier Universitaire de Nīmes · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Suicidal Ideation

Interventions

Type	Name	Description
OTHER	Baseline evaluation	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).
DRUG	1st perfusion of ketamine	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)
DRUG	1st perfusion of saline	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)
OTHER	Follow-up between perfusions	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.
DRUG	2nd perfusion of ketamine	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)
DRUG	2nd perfusion of saline	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)

Timeline

• Start date: 2015-04-01
• Primary completion: 2019-11-21
• Completion: 2019-11-21
• First posted: 2014-11-24
• Last updated: 2025-12-01

Locations

9 sites across 1 country: France