Clinical TrialSuicidalityKetaminePlaceboUnknown status

Emergency Ketamine Treatment of Suicidal Ideation

The objective of the current program of research will be to test whether intranasal ketamine treatment is more effective than placebo in reducing suicidal ideation in suicidal patients presenting for acute treatment in emergency department settings.

Target Enrollment
60 participants
Study Type
Phase II/III interventional
Design
Randomized, double Blind

Detailed Description

Randomised, double-blind, parallel-group trial (n=60) testing intranasal ketamine (0.2 mg/kg given as two doses on admission) versus saline placebo for reduction of suicidal ideation in emergency department patients.

Secondary objectives examine mu-opioid receptor genotypes and correlations of speech and facial movement patterns with reductions in suicidal ideation.

Study Protocol

Preparation

sessions

Dosing

2 sessions

Integration

sessions

Study Arms & Interventions

Intranasal Ketamine

experimental

Intranasal ketamine 0.2 mg/kg given as two separate doses on the day of admission.

Interventions

  • Ketamine0.2 mg/kg
    via Other• two doses• 2 doses total

    Intranasal administration by physician

Intranasal Saline Placebo

inactive

Intranasal saline placebo given as two separate doses on the day of admission.

Interventions

  • Placebo
    via Other• two doses• 2 doses total

    Saline placebo administered intranasally to match ketamine dosing

Participants

Ages
18 – 65
Sexes
Male & Female

Inclusion Criteria

  • 1. Males and females
  • 2. Ages 18-65
  • 3. All races and ethnicities
  • 4. Willing and able to provide informed consent
  • 5. A cutoff score of >3 on the Beck Scale for Suicidal Ideation
  • 6. >2 on the Columbia Scale for Suicide Severity Rating

Exclusion Criteria

  • 1. Pregnancy or lactation; women of reproductive potential must have a negative urine pregnancy test
  • 2. Post-partum state (within 2 months of delivery)
  • 3. Homicide risk as determined by clinical interview
  • 4. Any of the following Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) diagnoses:
  • 1. Any current primary psychotic disorder
  • 2. Acute intoxication or withdrawal from alcohol or any other substance of abuse, as determined by clinical interview and urine drug screen except opioids
  • 3. Use of any hallucinogen (except cannabis), in the last month
  • 4. Any dissociative disorder
  • 5. Pervasive developmental disorder
  • 6. Cognitive disorder
  • 7. Cluster A personality disorder
  • 8. Anorexia nervosa
  • 5. Treatment with any medication known to affect the N-methyl-D-aspartate (NMDA) receptor system (e.g., lamotrigine, acamprosate, memantine, riluzole, or lithium)
  • 6. Any known hypersensitivity or serious adverse effect with ketamine
  • 7. Any clinically-significant medication or condition that would preclude the use of ketamine

Study Details

  • Status
    Unknown status
  • Phase
    Phase IIPhase III
  • Type
    interventional
  • Design
    Randomizeddouble Blind
  • Target Enrollment60 participants
  • Timeline
    Start: 2016-08-01
    End: 2018-07-01
  • Compounds
    KetaminePlacebo
  • Topic
    Suicidality

Locations

University of Cincinnati — Cincinnati, Ohio, United States

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