Using IV Ketamine to Treat Suicidal Thoughts in Teens

A Double Blinded, Randomized, Placebo Controlled, Parallel Arm Pilot Trial of Intravenous Ketamine for Emergency Department Treatment of Suicidal Ideation in a Pediatric Population.

This study is testing if giving IV ketamine can quickly help teens with serious suicidal thoughts feel better while they're in the emergency department.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 20 (estimated)
• Ages: 12 Years to 17 Years
• Sex: All
• Sponsor: Children's Hospital of Eastern Ontario (other)
• Locations: 1 site (Ottawa, Ontario)
• Trial ID: NCT06366334 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates the use of intravenous ketamine as a rapid treatment for adolescents experiencing suicidal ideation in the emergency department. Given the high prevalence of suicidal thoughts among Canadian youth and the lack of effective acute interventions, this study aims to assess the feasibility and efficacy of ketamine, which has shown promise in adults, for this vulnerable population. Participants aged 12 to 17 who exhibit moderate to severe suicidal ideation will receive ketamine or a saline placebo, with the goal of determining if ketamine can significantly reduce their suicidal thoughts during their emergency visit.

Who should consider this trial

Good fit: Ideal candidates are adolescents aged 12 to 17 who are experiencing moderate to severe suicidal ideation.

Not a fit: Patients with acute intoxication from substances or those with serious physical injuries requiring urgent intervention may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a fast-acting intervention for adolescents in crisis, potentially saving lives and improving mental health outcomes.

How similar studies have performed: Previous studies have shown that intravenous ketamine can effectively reduce suicidal ideation in adults, but this approach has not yet been tested in adolescents.

Eligibility criteria

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 this trial is running

Ottawa, Ontario

• Children's Hospital Of Eastern Ontario — Ottawa, Ontario, Canada (RECRUITING)

Study contacts

• Study coordinator: Maala Bhatt, MD

Conditions: Suicidal Ideation, Suicidal Ideas