Clinical TrialSuicidalityKetaminePlaceboUnknown status

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

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.

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

Detailed Description

Pilot randomised, quadruple-blind, placebo-controlled parallel trial testing a single 0.5 mg/kg IV ketamine infusion (max 50 mg over 40 minutes) versus saline in adolescents (12–17 years) presenting to the ED with acute suicidal ideation.

Primary objective is feasibility and preliminary efficacy for rapid reduction in suicidal ideation; outcomes include SI measures, safety, and short-term clinical course with follow-up as specified in the protocol.

Study Protocol

Preparation

sessions

Dosing

1 sessions
40 min each

Integration

sessions

Study Arms & Interventions

IV ketamine

experimental

Single intravenous infusion of ketamine 0.5 mg/kg (max 50 mg) over 40 minutes.

Interventions

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

    50 mg maximum; 1 mg/mL concentration; administered over 40 min

Normal saline

inactive

Intravenous normal saline placebo 0.5 mL/kg (max 50 mL) over 40 minutes.

Interventions

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

    0.5 mL/kg, 50 mL maximum; matched infusion over 40 min

Participants

Ages
12 – 17
Sexes
Male & Female

Inclusion Criteria

  • Inclusion Criteria
  • 1. Responds "yes" to ASQ questionnaire at triage, which asks; "Are you having thoughts of killing yourself right now?"
  • 2. Moderate to severe suicidal ideation, defined as 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, as judged by the treating physician
  • 5. Speaks English or French

Exclusion Criteria

  • Exclusion Criteria
  • 1. Acute intoxication
  • 2. Previously enrolled in the current study or 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 of the following contraindications to ketamine based on the drug monograph:
  • 1. Known allergy or hypersensitivity to ketamine by patient history
  • 2. History of cerebrovascular accident (stroke or aneurysm)
  • 3. History of elevated intracranial pressure or idiopathic intracranial hypertension
  • 4. Significant hypertension requiring daily medication
  • 5. Severe cardiac decompensation
  • 7. On a Form 1
  • 8. Requires physical or chemical restraint
  • 9. History of violence while in hospital
  • 10. Assessment by a mental health practitioner during the current ED visit prior to study enrollment
  • 11. Pregnant or breastfeeding

Study Details

  • Status
    Unknown status
  • Phase
    Phase III
  • Type
    interventional
  • Design
    Randomizedquadruple Blind
  • Target Enrollment20 participants
  • Timeline
    Start: 2023-06-01
    End: 2024-07-31
  • Compounds
    KetaminePlacebo
  • Topic
    Suicidality

Locations

CHEO — Ottawa, Ontario, Canada

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