Clinical TrialDepressive DisordersKetaminePlaceboTerminated

Subanesthetic IV Bolus Ketamine in the Treatment of Acute Depression

The objective of this double-blinded placebo-controlled pilot study is to determine whether a single sub-anesthetic rapid IV bolus dose of ketamine administered to acutely depressed patients with or without suicidality has a significant rapid antidepressant effect in the acutely depressed population.

Target Enrollment
20 participants
Study Type
Phase I interventional
Design
Randomized, double Blind

Detailed Description

Randomised, placebo-controlled ED study comparing a single rapid IV bolus of ketamine (0.2 mg/kg over 1–2 minutes) with saline in acutely depressed admitted patients; acute outcomes measured at 40, 80, 120 and 240 minutes.

Primary outcomes are change in depressive and suicidal ideation scales (BSS, BHS) acutely; secondary outcome is sustained reduction in BDI at 2 weeks. Participants are medically monitored for at least 240 minutes then admitted to psychiatric ward for ≥24 hours and reassessed prior to discharge and at two weeks.

Study Protocol

Preparation

sessions

Dosing

1 sessions
240 min each

Integration

sessions

Study Arms & Interventions

Ketamine

experimental

Single subanesthetic IV bolus ketamine given in ED prior to psychiatric admission; outcomes assessed acutely and at 2 weeks.

Interventions

  • Ketamine0.2 mg/kg
    via IV• single dose

    Rapid IV bolus administered over 1–2 minutes; monitoring for 240 minutes.

Placebo (saline)

inactive

Normal saline IV bolus equal volume to ketamine.

Interventions

  • Placebo
    via IV• single dose

    0.9% normal saline bolus equal volume to active dose.

Participants

Ages
18 – 65
Sexes
Male & Female

Inclusion Criteria

  • Inclusion Criteria:
  • 1. BSS greater than 4
  • 2. BHS greater than 8
  • 3. BDI greater than 19
  • 4. Ability to give informed consent.
  • 5. Active Duty military status.
  • 6. Verified negative qualitative pregnancy test.
  • 7. All participants must be accepted for psychiatric admission to the hospital PRIOR to consideration for enrollment in this study.

Exclusion Criteria

  • Exclusion Criteria:
  • 1. Psychosis or Bipolar Disorder.
  • 2. Pregnancy
  • 3. Involuntary Status on presentation to the ED.
  • 4. UDS positive for illicit drugs of abuse.
  • 5. Blood Alcohol level greater than zero.
  • 6. Previous enrollees in this treatment protocol will be excluded from repeat participation.
  • 7. Any patient brought for command directed psychiatric evaluation.
  • 8. Specific contraindications to the use of ketamine including elevated intracranial pressure, uncontrolled hypertension, coronary artery disease, aneurysms, thyrotoxicosis, CHF, recent head or eye injury, angina; patients in whom significant BP elevation would be hazardous; patients currently using conivaptan, Disatinib, peginterferon alfa-2b, quazepam, tocilizumab.

Study Details

  • Status
    Terminated
  • Phase
    Phase I
  • Type
    interventional
  • Design
    Randomizeddouble Blind
  • Target Enrollment20 participants
  • Timeline
    Start: 2011-01-12
    End: 2013-01-06
  • Compounds
    KetaminePlacebo
  • Topic
    Depressive Disorders

Locations

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

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