Clinical TrialSuicidalityKetaminePlaceboKetaminePlaceboCompleted

Treatment of Suicidal Ideation With Intravenous Ketamine Infusion

This study is dedicated to achieving better treatments for suicidal thoughts. Specifically, the investigators are studying the effect of a medication called ketamine to quickly treat suicidal thoughts and depression.

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

Detailed Description

Pilot randomised, quadruple-blind, parallel-design study comparing a single IV infusion of ketamine (0.2 mg/kg) versus saline in patients with suicidal ideation and depression; includes cohorts with and without opioid use disorder.

The intervention is given in addition to usual psychiatric care; safety and change in suicidal ideation and depressive symptoms are primary outcomes in this small, proof-of-concept trial.

Study Protocol

Preparation

sessions

Dosing

1 sessions

Integration

sessions

Study Arms & Interventions

Ketamine (Depression)

experimental

Patients with suicidal ideation and depression (no substance use disorder) receiving IV ketamine 0.2 mg/kg as a one-time dose.

Interventions

  • Ketamine0.2 mg/kg
    via IV• single dose• 1 doses total

    Single IV infusion 0.2 mg/kg

Placebo (Depression)

inactive

Patients with suicidal ideation and depression (no substance use disorder) receiving comparable volume saline infusion.

Interventions

  • Placebo
    via IV• single dose

    Saline infusion (placebo)

Ketamine (Opioid use)

experimental

Patients with suicidal ideation, depression and opioid use disorder receiving IV ketamine 0.2 mg/kg as a one-time dose.

Interventions

  • Ketamine0.2 mg/kg
    via IV• single dose• 1 doses total

    Single IV infusion 0.2 mg/kg

Placebo (Opioid use)

inactive

Patients with suicidal ideation, depression and opioid use disorder receiving comparable volume saline infusion.

Interventions

  • Placebo
    via IV• single dose

    Saline infusion (placebo)

Participants

Ages
19 – 64
Sexes
Male & Female

Inclusion Criteria

  • Inclusion Criteria:
  • 1. Age : 19-64
  • 2. Significant suicidality score on the Columbia Suicide Severity Rating Scale (C-SSRS)
  • 3. Willing and able to provide informed consent.
  • 4. Individuals with current substance abuse are allowed

Exclusion Criteria

  • Exclusion Criteria:
  • 1. Pregnant or lactating; women of reproductive potential must have a negative urine pregnancy test (urine dipstick method)
  • 2. Post-Partum state : defined as being within 2 months of delivery or miscarriage
  • 3. Homicide risk as determined by clinical interview
  • 4. Treatment with any medication known to specifically target the glutamate-NMDA receptor system (ie lamotrigine, acamprosate, memantine, riluzole or lithium)
  • 5. Any known hypersensitivity or serious adverse effect associated with ketamine treatment.
  • 6. Any clinically significant medical condition or therapy that would preclude treatment with ketamine, to include recent myocardial infarction or unstable angina
  • 7. Medically unstable, including acute withdrawal from alcohol or benzodiazepines requiring the use of benzodiazepine treatment.
  • 8. Any of the following DSM-IV diagnoses or categories:
  • * Any current psychosis or history of a non-mood psychotic disorder (e.g., schizophrenia)
  • * Currently in a manic or mixed episode
  • * Current use (defined by urine dipstick test) or abuse of hallucinogenic drugs (except marijuana) such as phencyclidine
  • * Any dissociative disorder
  • * Any pervasive developmental disorder (e.g., autism)
  • * A cognitive disorder (e.g., Alzheimer's Disease)
  • * Cluster A personality disorder (e.g., schizoid or schizotypal); note that cluster B and C personality disorders may be included
  • * Any eating disorder

Study Details

Locations

University of Alabama Birmingham — Birmingham, Alabama, United States

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