Clinical TrialBipolar DisorderKetaminePlaceboCompleted

Ketamine for Suicidality in Bipolar Depression

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

Target Enrollment
16 participants
Study Type
Phase I/II interventional
Design
Randomized, quadruple Blind

Detailed Description

Randomised, double-blind, parallel-group study (n=16) comparing a single IV infusion of ketamine 0.5 mg/kg with midazolam 0.02 mg/kg for rapid reduction of suicidal ideation in bipolar depression.

Participants require voluntary inpatient admission to NYSPI for the infusion phase; follow-up includes weekly research interviews for 6 weeks; non-responders to midazolam may be offered an open ketamine infusion.

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• 1 doses total

    Infusion over ~40 minutes

Midazolam

active comparator

Single IV infusion of midazolam 0.02 mg/kg over ~40 minutes (active comparator); non-responders to midazolam may be offered open ketamine

Interventions

  • Placebo0.02 mg/kg
    via IV• single dose• 1 doses total

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

Participants

Ages
18 – 65
Sexes
Male & Female

Inclusion Criteria

  • INCLUSION CRITERIA:
  • Bipolar 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
  • Patients will only be enrolled if they agree to voluntary admission to an inpatient research unit at the New York State Psychiatric Institute (NYSPI) for infusion phase of treatment.
  • 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, oral contraceptive pills
  • Able to provide informed consent
  • Subjects 61-65 years old must score 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
  • Pregnancy and/or lactation
  • Current psychotic symptoms
  • Contraindication to any study treatment
  • Current or past ketamine abuse or dependence ever (lifetime); any other drug or alcohol dependence within past 6 months; suicidality only due to binge substance use or withdrawal
  • 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

Study Details

  • Status
    Completed
  • Phase
    Phase IPhase II
  • Type
    interventional
  • Design
    Randomizedquadruple Blind
  • Target Enrollment16 participants
  • Timeline
    Start: 2013-01-09
    End: 2018-01-10
  • Compounds
    KetaminePlacebo
  • Topic
    Bipolar Disorder

Locations

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

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