Actively Recruiting

Phase Not Applicable
Age: 12Years - 17Years
All Genders
NCT06366334

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

Led by Children's Hospital of Eastern Ontario · Updated on 2024-06-05

20

Participants Needed

1

Research Sites

23 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 12Years - 17Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Responds "yes" to Ask Suicide Screening Question (ASQ) #5 asking if they are having thoughts of killing themselves right now
  • Moderate to severe suicidal ideation, defined as a score  3 on the first 5 questions of the Beck Scale for Suicidal Ideation (SSI5)
  • Age 12 to 17 years, inclusive
  • Medically cleared by treating physician, with no serious physical injury or acute ingestion requiring urgent intervention or monitoring
Not Eligible

You will not qualify if you...

  • Acute intoxication from any substance including alcohol
  • Previously or currently enrolled in this or another clinical trial
  • History of intellectual disability or autism spectrum disorder
  • Active or past psychosis or psychotic disorder
  • History of non-psychiatric neurological disorders such as epilepsy
  • Contraindications to ketamine including allergy, cerebrovascular disease, elevated intracranial pressure, severe hypertension, or severe cardiac problems
  • On an involuntary psychiatric hold
  • Requires physical or chemical restraint
  • History of violence while in hospital
  • Pregnant or breastfeeding
  • Received opioids within 2 hours prior to study screening

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Children's Hospital Of Eastern Ontario

Ottawa, Ontario, Canada, K1H 8L1

Actively Recruiting

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Research Team

M

Maala Bhatt, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

QUADRUPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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