Clinical TrialSuicidalityKetaminePlaceboRecruiting

Study of IV Ketamine for Emergency Department Treatment of Adolescent Suicidal Ideation (KSI)

This double-blinded, randomized, placebo-controlled, parallel-arm pilot trial (n=20) will investigate the efficacy of intravenous ketamine (0.5 mg/kg IV) versus saline for emergency department treatment of suicidal ideation in adolescents.

Target Enrollment
20 participants
Study Type
Phase NA interventional
Design
Randomized, quadruple Blind

Detailed Description

Suicidal ideation is common in Canadian adolescents and a frequent reason for emergency department presentation; there are currently no rapid-acting ED treatments for acute suicidal ideation in youth.

This pilot study aims to assess feasibility and preliminary efficacy of a single IV ketamine infusion (0.5 mg/kg, max 50 mg) compared with saline placebo for reducing suicidal ideation in 12–17-year-olds presenting to a paediatric ED.

Design: randomized, quadruple-blind, parallel-group trial (n≈20) with acute assessment of suicidal ideation and short-term follow-up to inform larger paediatric trials and potential ED implementation.

Study Protocol

Preparation

sessions

Dosing

1 sessions
40 min each

Integration

sessions

Study Arms & Interventions

Ketamine

experimental

IV ketamine 0.5 mg/kg (max 50 mg) infused over 40 minutes.

Interventions

  • Ketamine0.5 mg/kg
    via IV• single dose• 1 doses total

    1 mg/mL solution; 50 mg maximum; infusion over 40 minutes.

Normal saline

inactive

IV normal saline volume-matched placebo (0.5 mL/kg, max 50 mL) over 40 minutes.

Interventions

  • Placebo0.5 ml/kg
    via IV• single dose• 1 doses total

    Volume-matched normal saline placebo; 50 mL maximum; infusion over 40 minutes.

Participants

Ages
12 – 17
Sexes
Male & Female

Inclusion Criteria

  • 1. Responds "yes" to Ask Suicide Screening Question (ASQ) #5 at triage ("Are you having thoughts of killing yourself right now?")
  • 2. Moderate to severe suicidal ideation: 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 for participation as judged by treating physician: a) No evidence of serious physical injury requiring urgent intervention; b) No evidence of acute ingestion requiring monitoring, blood tests, imaging or ECG, or if present they have completed required 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 contraindication to ketamine per drug monograph: a) Known allergy or hypersensitivity to ketamine; 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

Study Details

  • Status
    Recruiting
  • Phase
    Phase NA
  • Type
    interventional
  • Design
    Randomizedquadruple Blind
  • Target Enrollment20 participants
  • Timeline
    Start: 2024-01-15
    End: 2024-09-30
  • Compounds
    KetaminePlacebo
  • Topic
    Suicidality

Locations

Children's Hospital Of Eastern Ontario — Ottawa, Ontario, Canada

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