Clinical TrialSuicidalityKetaminePlaceboTemporarily not available

IM Ketamine vs Midazolam for Suicidal ER Patients

We propose a clinical trial of intramuscular ketamine in depressed ED patients with high-risk suicidality, which if successful would support a novel, easy-to-use, scalable intervention for busy emergency clinicians to implement.

Target Enrollment
90 participants
Study Type
Phase IV interventional
Design
Randomized, quadruple Blind

Detailed Description

Randomised, double-blind, parallel-group trial (2:1 ketamine:midazolam) in adults presenting to the psychiatric ED with suicidality; single IM injection of ketamine 0.5 mg/kg versus midazolam 0.06 mg/kg with monitoring and blood draws, admission for standard inpatient care, and follow-up to 4 weeks post-discharge.

Rationale: rapid reduction of suicidal ideation with subanesthetic ketamine may provide a scalable emergency intervention; biosamples (60 and 90 min) and genetic sample collected for mechanistic analyses.

Operational note: the NYSPI site is paused (institutional pause on human subjects research since June 2023) following an OHRP FWA restriction; other sites remain subject to local approvals.

Study Protocol

Preparation

sessions

Dosing

1 sessions
120 min each

Integration

sessions

Study Arms & Interventions

Ketamine

experimental

IM ketamine 0.5 mg/kg single injection

Interventions

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

    Single IM injection; blood draws at 60 and 90 min; genetic sample stored.

Midazolam

active comparator

IM midazolam 0.06 mg/kg single injection

Interventions

  • Placebo0.06 mg/kg
    via IM• single dose• 1 doses total

    Midazolam 0.06 mg/kg IM single injection (active comparator).

Participants

Ages
18 – 65
Sexes
Male & Female

Inclusion Criteria

  • Inclusion Criteria:
  • DSM5 unipolar or bipolar (I, II, or Unspecified) major depressive episode
  • Presenting to emergency department and assessed by psychiatrist staff as needing inpatient treatment due to suicidality
  • Participant agrees to voluntary inpatient psychiatric admission
  • Beck Scale for Suicidal Ideation score of 4 or higher

Exclusion Criteria

  • Exclusion Criteria:
  • Substance use disorder in past 2 weeks
  • Current psychosis or mania
  • Intellectual disability
  • Inadequate understanding of English and/or lack of capacity for informed consent
  • Pregnancy or lactation
  • Medical contraindication to ketamine or midazolam
  • Unstable medical or neurological illness such as uncontrolled hypertension, significant cardiac arrhythmia, unstable cerebrovascular disease. Chronic, stable medical conditions such as controlled hypertension or diabetes will not be excluded.

Study Details

  • Status
    Temporarily not available
  • Phase
    Phase IV
  • Type
    interventional
  • Design
    Randomizedquadruple Blind
  • Target Enrollment90 participants
  • Timeline
    Start: 2021-01-02
    End: 2025-03-01
  • Compounds
    KetaminePlacebo
  • Topic
    Suicidality

Locations

Comprehensive Psychiatric Emergency Department of Columbia University Medical Center — New York, New York, United States

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