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

NCT05468840 | Unknown Phase 3 DMC

• 1 other identifier: 0000001
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Suicidal Ideation

Keywords

ketamine; emergency department; pediatrics

Outcome Measures

Primary Outcomes (1)

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

  Data analysis for feasibility will be descriptive in nature and there will be no formal hypothesis testing. The percentage of eligible patients who complete the study will be reported.

  Baseline

Secondary Outcomes (14)

• Baseline distribution of responses to the first 5 questions of Beck Scale for Suicidal Ideation (SSI5)

  Baseline

• Baseline distribution of responses to the suicide item (#10) from the Montgomery-Asberg Depression Rating Scale (MARDS10)

  Baseline

• Baseline distribution of responses to the suicide item (#9) from the Beck Depression Index (BDI9).

  Baseline

• Baseline pragmatic assessment of the first 5 questions of the Beck Scale for Suicidal Ideation (SSI5), the suicide item (#10) from the Montgomery-Asberg Depression Rating Scale (MADRS10), and the suicide item (#9) from the Beck Depression Index (BDI9).

  Baseline

• Blinding assessment

  Baseline

Study Arms (2)

Intravenous ketamine infusion

EXPERIMENTAL

Participants in the intervention group will receive 0.5mg/kg of 1mg/mL intravenous ketamine (50 mg maximum) over 40 minutes.

Drug: Ketamine Hydrochloride

Intravenous normal saline infusion

PLACEBO COMPARATOR

Participants in the control group will receive 0.5mL/kg intravenous normal saline (50 ml maximum) over 40 minutes.

Drug: Normal saline

Interventions

Ketamine Hydrochloride DRUG

see study arm description

Also known as: ketamine

Intravenous ketamine infusion

Normal saline DRUG

see study arm description

Intravenous normal saline infusion

Eligibility Criteria

• Age: 12 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Responds "yes" to ASQ questionnaire at triage, which asks; "Are you having thoughts of killing yourself right now?"
• Moderate to severe suicidal ideation, defined as score ≥ 3 on the first 5 questions of the Beck Scale for Suicidal Ideation (SSI5)
• Age 12 to 17 years, inclusive
• Medically clear, as judged by the treating physician
• Speaks English or French

You may not qualify if:

• Acute intoxication
• Previously enrolled in the current study or another clinical trial
• History of intellectual disability or autism spectrum disorder by patient/parent report
• Active, or history of, psychosis or psychotic disorder
• History of non-psychiatric neurologic disorder (e.g., epilepsy)
• Any of the following contraindications to ketamine based on the drug monograph:
• Known allergy or hypersensitivity to ketamine by patient history
• History of cerebrovascular accident (stroke or aneurysm)
• History of elevated intracranial pressure or idiopathic intracranial hypertension
• Significant hypertension requiring daily medication
• Severe cardiac decompensation
• On a Form 1
• Requires physical or chemical restraint
• History of violence while in hospital
• Assessment by a mental health practitioner during the current ED visit prior to study enrollment

Sponsors & Collaborators

• University of Ottawa: lead

Study Sites (1)

CHEO

Ottawa, Ontario, K1H 8L1, Canada

Location

Related Publications (1)

• Schlegelmilch M, Plint AC, Barrowman N, Gray C, Bhatt M. Intravenous ketamine for emergency department treatment of suicidal ideation in a paediatric population: protocol for a double-blind, randomised, placebo-controlled, parallel-arm pilot trial (KSI study). BMJ Open. 2024 Jul 5;14(7):e085681. doi: 10.1136/bmjopen-2024-085681.

  PMID: 38969374 DERIVED

MeSH Terms

Conditions

Suicidal Ideation; Emergencies

Interventions

Ketamine; Saline Solution

Condition Hierarchy (Ancestors)

Suicide; Self-Injurious Behavior; Behavioral Symptoms; Behavior; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Central Study Contacts

Michael Schlegelmilch, MD, MPH

CONTACT

1-613-737-7600; mschlegelmilch@cheo.on.ca

Maala Bhatt, MD, Msc

CONTACT

mbhatt@cheo.on.ca

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 11, 2022
• First Posted: July 21, 2022
• Study Start: June 1, 2023
• Primary Completion: December 1, 2023
• Study Completion: July 1, 2024
• Last Updated: February 13, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)