This double-blinded, randomized, placebo-controlled, parallel-arm pilot trial (n=20) will investigate the efficacy of intravenous ketamine for emergency department treatment of suicidal ideation (SI) in adolescents.
The study aims to determine the feasibility of using intravenous ketamine to rapidly alleviate SI in adolescents presenting to the emergency department. Adolescents aged 12 to 17 years, with moderate to severe suicidal ideation, who are medically clear and fluent in English or French, will be included. The intervention group will receive an intravenous ketamine infusion, while the control group will receive an intravenous normal saline infusion.
The primary outcome measure is the feasibility of the study, assessed by the percentage of eligible patients able to complete the study protocol. Secondary outcome measures include the distribution of responses to various suicidal ideation assessment tools and treatment efficacy measured at different time points post-treatment start. The study is expected to start in June 2023 and complete in July 2024.
It is conducted at CHEO in Ottawa, Ontario, Canada, and is sponsored by the University of Ottawa.
Trial Details
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.NCT Number NCT05468840
Sponsors & Collaborators
Children's Hospital of Eastern OntarioCHEO is a pediatric health center in Ottawa, Canada, providing specialized care for young patients, including medical, surgical, mental health, & rehabilitation services.
University of Ottawa
The University of Ottawa launched The Psychedelics & Spirituality Studies Initiative (PSSI) in 2021. PSSI is an interdisciplinary group of faculty and graduate students who share a common interest in the study of psychedelics, spirituality and integrative healing.