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Unknown statusPhase 3

Study of IV Ketamine for Emergency Department Treatment of Adolescent Suicidal Ideation

NCT05468840 · University of Ottawa

Closed to entry
Status
Not accepting participants
Phase 3
Phase
20
Target enrolment
1
Study sites
Outside the US

What it is testing

Summary

Approximately 20% of Canadian adolescents experience thoughts of suicide, or suicidal ideation (SI), and suicide is the second leading cause of death among Canadians aged 15-19 years. The emergency department at CHEO sees approximately four patients per day with SI. Even though this is a medical emergency, there are no fast-acting treatments available. Ketamine is a medication that is commonly used to safely sedate children who require painful procedures in the emergency department. For nearly ten years, intravenous ketamine has also been shown to rapidly reduce SI in adults. However, ketamine as a treatment for SI has never been studied in adolescents. The primary study objective is to pilot a clinical trial that investigates intravenous ketamine to emergently treat SI in adolescents. If intravenous ketamine can relieve symptoms of SI for youth, this would have tremendous effects on patients and would dramatically change how physicians treat adolescent mental health emergencies. If ketamine is effective for several weeks, as it is in adults, it will help temporize patients until they receive more long-term psychiatric care. At the system level, it has the potential to reduce emergency visits and lengthy admissions. The investigators feel that the results of this study will be generalizable to pediatric centres across Canada and beyond.

Summary as written by the trial’s own sponsor and published on ClinicalTrials.gov API v2. It is the sponsor’s description, reproduced unedited, not an assessment by this site.

What counts as success

Primary outcome measures

  • Feasibility of the study as measured by the percentage of eligible of patients able to complete the study protocol.

    Measured over Baseline

A trial succeeds or fails on its primary outcome, declared in advance. Everything else it reports is secondary by definition.

Who can take part

Eligibility, as published

12 Years to 17 Years
Ages
All
Sex
Not accepted
Healthy volunteers
Inclusion Criteria 1. Responds "yes" to ASQ questionnaire at triage, which asks; "Are you having thoughts of killing yourself right now?" 2. Moderate to severe suicidal ideation, defined as score ≥ 3 on the first 5 questions of the Beck Scale for Suicidal Ideation (SSI5) 3. Age 12 to 17 years, inclusive 4. Medically clear, as judged by the treating physician 5. Speaks English or French Exclusion Criteria 1. Acute intoxication 2. Previously enrolled in the current study or another clinical trial 3. History of intellectual disability or autism spectrum disorder by patient/parent report 4. Active, or history of, psychosis or psychotic disorder 5. History of non-psychiatric neurologic disorder (e.g., epilepsy) 6. Any of the following contraindications to ketamine based on the drug monograph: 1. Known allergy or hypersensitivity to ketamine by patient history 2. History of cerebrovascular accident (stroke or aneurysm) 3. History of elevated intracranial pressure or idiopathic intracranial hypertension 4. Significant hypertension requiring daily medication 5. Severe cardiac decompensation 7. On a Form 1 8. Requires physical or chemical restraint 9. History of violence while in hospital 10. Assessment by a mental health practitioner during the current ED visit prior to study enrollment 11. Pregnant or breastfeeding

Where

1 study site

FacilityCityRegionCountry
CHEOOttawaOntarioCanada

On the registry

Contact the trial directly

This site does not enrol anyone and is not involved in this trial. To ask about taking part, use the sponsor’s own contact details on the official registry record, which is also where the most current version of everything above lives.

Before you do, the preparation checklist lists what a site will ask you on a first call and what is worth asking them. It is free and collects nothing.

NCT05468840 on ClinicalTrials.gov →

Last updated in the registry 2023-02-13. Registry records change; this page reflects the data build of 2026-08-25.

Related

Where this trial sits