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

NCT06366334 | Recruiting DMC

• 1 other identifier: 23/02E
• 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; Suicidal Ideas

Outcome Measures

Primary Outcomes (1)

• Proportion of eligible participants who complete the study protocol

  This is a feasibility measure; the investigators will report the number of patients who are screened for participation, are eligible, eligible and consent, complete the intervention, complete study follow-up

  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 (MADRS10)

  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

• Assessment of blinding

  Baseline

Other Outcomes (5)

• Safety Outcome 1: Clinically significant tachycardia

  Enrollment visit

• Safety Outcome 2: Clinically significant hypertension

  Enrollment visit

• Safety Outcome 3: Vomiting

  Enrollment visit

Study Arms (2)

Ketamine

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

Normal Saline

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 arm description

Also known as: Ketamine

Ketamine

Normal saline DRUG

See arm description

Normal Saline

Eligibility Criteria

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

You may qualify if:

• Responds "yes" to Ask Suicide Screening Question (ASQ) #5 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 (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.

You may not qualify if:

• Acute intoxication from any substance, including alcohol
• Previously enrolled in the current study or currently enrolled in 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: 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
• On an involuntary psychiatric hold
• Requires physical or chemical restraint
• History of violence while in hospital
• Pregnant or breastfeeding
• Received opioids in the 2-hours prior to study screening

Sponsors & Collaborators

• Children's Hospital of Eastern Ontario: lead

Study Sites (1)

Children's Hospital Of Eastern Ontario

Ottawa, Ontario, K1H 8L1, Canada

RECRUITING

MeSH Terms

Conditions

Suicidal Ideation

Interventions

Ketamine; Saline Solution

Condition Hierarchy (Ancestors)

Suicide; Self-Injurious Behavior; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

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

Study Officials

• Tyrus Crawford, BA

  CHEO

  STUDY DIRECTOR

Central Study Contacts

Maala Bhatt, MD

CONTACT

6137377600; mbhatt@cheo.on.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• 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: Associate Professor of Pediatrics, Director of Emergency Research

Study Record Dates

• First Submitted: April 10, 2024
• First Posted: April 15, 2024
• Study Start: January 15, 2024
• Primary Completion: May 29, 2024
• Study Completion: June 28, 2024
• Last Updated: June 5, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)