Clinical TrialSuicidalityKetaminePlaceboWithdrawn

A Study to Decrease Suicidal Thinking Using Ketamine

Randomised, placebo-controlled trial in active-duty military patients hospitalised for suicidal thinking (planned n=40) comparing a single IV bolus of ketamine 0.2 mg/kg versus placebo, with acute monitoring and follow-up to 10 weeks.

Target Enrollment
40 participants
Study Type
Phase III interventional
Design
Randomized, double Blind

Detailed Description

Background: Sub-anesthetic IV ketamine has shown rapid reductions in suicidal ideation in prior studies; this trial tests a single 0.2 mg/kg IV bolus in military patients hospitalised for suicidal thinking.

Design: Randomised, double-blind, parallel-group comparison of ketamine versus placebo with acute monitoring for 240 minutes post-dose and follow-up assessments at next day, discharge, 2 weeks and 10 weeks; safety surveillance via electronic medical record for up to one year.

Study Protocol

Preparation

sessions

Dosing

1 sessions
240 min each

Integration

sessions

Study Arms & Interventions

Ketamine 0.2 mg/kg

experimental

Single IV bolus of ketamine 0.2 mg/kg with monitoring of suicidal thinking and mood.

Interventions

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

    Rapid IV bolus; acute monitoring for 240 minutes post-dose

Placebo

inactive

Placebo IV bolus with identical monitoring schedule.

Interventions

  • Placebo
    via IV• single dose• 1 doses total

    Saline placebo administered as IV bolus

Participants

Ages
18 – 65
Sexes
Male & Female

Inclusion Criteria

  • Inclusion Criteria:
  • Voluntarily, psychiatrically hospitalized at NMCSD within the last 12 hours for suicidal thinking
  • BSS greater than 4
  • BHS greater than 8
  • BDI greater than 19
  • Ability to give informed consent
  • Active duty military status
  • Verified negative pregnancy test for females

Exclusion Criteria

  • Exclusion Criteria:
  • Psychosis or bipolar disorder
  • Pregnancy
  • Involuntary status on presentation to the ED
  • Positive for illicit drugs of abuse
  • Blood alcohol level greater than zero
  • Previous enrollees in this treatment protocol will be excluded from repeat participation
  • Any patient brought for command directed psychiatric evaluation
  • Specific contraindication to the use of ketamine including elevated intracranial pressure, uncontrolled hypertension, coronary artery disease, aneurysms, thyrotoxicosis, congestive heart failure, recent history of head or eye injury, or angina
  • Patients in whom significant elevation of blood pressure would be a serious hazard
  • Concurrent use of contraindicated medications (e.g., conivaptan, dasatinib, peginterferon alfa-2b, quazepam, tocilizumab)

Study Details

  • Status
    Withdrawn
  • Phase
    Phase III
  • Type
    interventional
  • Design
    Randomizeddouble Blind
  • Target Enrollment40 participants
  • Timeline
    Start: 2016-08-01
    End: 2017-08-01
  • Compounds
    KetaminePlacebo
  • Topic
    Suicidality

Locations

Naval Medical Center San Diego — San Diego, California, United States

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