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

NCT06366334 · KSI · Children's Hospital of Eastern Ontario

Closed to entry
Status
Not accepting participants
Not applicable
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

  • Proportion of eligible participants who 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 Ask Suicide Screening Question (ASQ) #5 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 (deemed fit for participation in the trial), as judged by the treating physician. Minimum criteria required to be deemed medically clear are: a) No evidence of serious physical injury requiring urgent intervention b) No evidence of acute ingestion requiring monitoring, blood tests, imaging or ECG or in the context of acute ingestion they have satisfied the requisite number of hours of post-ingestion monitoring with no further need for intervention. Exclusion Criteria: 1. Acute intoxication from any substance, including alcohol 2. Previously enrolled in the current study or currently enrolled in 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: a) Known allergy or hypersensitivity to ketamine by patient history b) History of cerebrovascular accident (stroke or aneurysm) c) History of elevated intracranial pressure or idiopathic intracranial hypertension d) Significant hypertension requiring daily medication e) Severe cardiac decompensation 7. On an involuntary psychiatric hold 8. Requires physical or chemical restraint 9. History of violence while in hospital 10. Pregnant or breastfeeding 11. Received opioids in the 2-hours prior to study screening

Where

1 study site

FacilityCityRegionCountry
Children's Hospital Of Eastern OntarioOttawaOntarioCanada

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.

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NCT06366334 on ClinicalTrials.gov →

Last updated in the registry 2024-06-05. Registry records change; this page reflects the data build of 2026-08-25.

Related

Where this trial sits