Clinical TrialSuicidalityKetaminePlaceboCompleted

Ketamine in the Treatment of Suicidal Depression

This study is designed to compare the effectiveness of two medications, Ketamine and Midazolam, for rapidly relieving suicidal thoughts in people suffering from depression.

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

Detailed Description

Randomised, double-blind, parallel-group trial in depressed adults with suicidal ideation comparing a single IV infusion of ketamine (0.5 mg/kg) versus midazolam (0.02 mg/kg); infusions administered over ~40 minutes.

Nonresponders who received midazolam may be offered a second ketamine infusion; participants receive weekly follow-up interviews for 6 weeks and may be offered standard antidepressant treatment thereafter. Study requires brief inpatient admission at NYSPI.

Study Protocol

Preparation

sessions

Dosing

1 sessions
40 min each

Integration

sessions

Study Arms & Interventions

Ketamine

experimental

Single IV infusion of ketamine 0.5 mg/kg over ~40 minutes

Interventions

  • Ketamine0.5 mg/kg
    via IV• single dose

    IV infusion over ~40 minutes

Midazolam

active comparator

Single IV infusion of midazolam 0.02 mg/kg over ~40 minutes (active comparator)

Interventions

  • Placebo0.02 mg/kg
    via IV• single dose

    Midazolam 0.02 mg/kg IV over ~40 minutes (active comparator)

Participants

Ages
18 – 65
Sexes
Male & Female

Inclusion Criteria

  • INCLUSION CRITERIA:
  • Unipolar depression with current major depressive episode (MDE). Participants may be psychiatric medication-free, or if on psychiatric medication, not responding adequately given current MDE with suicidal ideation.
  • Moderate to severe suicidal ideation
  • 18-65 years old
  • Participants must agree to a voluntary admission to an inpatient research unit at the New York State Psychiatric Institute (NYSPI) for the infusion(s), for a brief stay, or longer if clinically necessary.
  • Pre-menopausal female participants of child-bearing potential must be willing to use an acceptable form of birth control during study participation such as condoms, diaphragm, or oral contraceptive pills.
  • Able to provide informed consent
  • Participants 61-65 years old must score a 25 or higher on the Mini-Mental State Examination (MMSE) at screening.

Exclusion Criteria

  • EXCLUSION CRITERIA:
  • Unstable medical condition or neurological illness, including baseline hypertension (BP>140/90) or significant history of cardiovascular illness.
  • Significant ECG abnormality
  • Pregnant or lactating
  • Diagnosis of bipolar disorder or psychotic disorder
  • Contraindication to any study treatment.
  • Inadequate understanding of English.
  • Prior ineffective trial of or adverse reaction to Ketamine or Midazolam.
  • Opiate use greater than total daily dose of 20mg Oxycodone or equivalent during the 3 days pre-infusion.
  • A diagnosis of sleep apnea.

Study Details

  • Status
    Completed
  • Phase
    Phase IV
  • Type
    interventional
  • Design
    Randomizedquadruple Blind
  • Target Enrollment82 participants
  • Timeline
    Start: 2021-06-01
    End: 2017-07-31
  • Compounds
    KetaminePlacebo
  • Topic
    Suicidality

Locations

Columbia University/New York State Psychiatric Institute — New York, New York, United States

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