Trial intelligence / Profile preview

Intravenous Ketamine for Suicidal Ideation in Adolescents

NCT05468840Phase 3

Key facts

Status: Unknown
Start: Jun 2023
Primary completion: Dec 2023
Countries: 1
Sponsor: University of Ottawa
Modality: Small Molecules

Drugs: ketamine
Conditions: suicidal ideation

Overview

Phase 3, randomised, double-blind trial in suicidal ideation comparing Ketamine with Placebo (2 arms). Primary endpoint: Feasibility of the study. Status: unknown.

Design

2 arms

Study design: RandomizedDouble-blind

Ketamine
0.5mg/kg IV Ketamine
Placebo
Normal Saline

Who it enrols

Adolescents (12-17) with moderate to severe suicidal ideation in the ED. Excludes acute intoxication, psychosis, autism, intellectual disability, and those on involuntary psychiatric hold (Form 1).

Endpoints

Primary

Feasibility of the study

Secondary

Beck Scale for Suicidal Ideation (first 5 questions)7 days
Montgomery-Asberg Depression Rating Scale (suicide item #10)7 days
Beck Depression Index (suicide item #9)7 days
Blinding assessment
Admission to Hospital18 months
Length of Stay in Hospital18 months
Revisits to the ED18 months

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