Clinical TrialSuicidalityKetaminePlaceboCompleted

Effect of Ketamine vs. Active Placebo on Suicidal Ideation in Depressed Inpatients With Major Depressive Disorder or Bipolar Depression

Pilot double-blind randomized inpatient trial (n=9 actual) comparing IV ketamine (0.5 mg/kg) + TAU vs midazolam (0.045 mg/kg) + TAU, six infusions over two weeks, for reducing suicidal ideation in MDD and bipolar depression.

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

Detailed Description

This double-blind, randomized, parallel-group pilot study tests whether repeated IV ketamine plus treatment as usual reduces suicidal ideation more than an active placebo (midazolam) plus treatment as usual in inpatients with major depressive disorder or bipolar depression.

Participants receive six infusions (0.5 mg/kg ketamine or 0.045 mg/kg midazolam) infused over ~40 minutes across two weeks; primary outcomes include SSI and C-SSRS at days 14 and 42, with MADRS and safety monitoring as secondary measures.

Study Protocol

Preparation

sessions

Dosing

6 sessions
40 min each

Integration

sessions

Study Arms & Interventions

Ketamine + TAU

experimental

IV ketamine plus treatment as usual (TAU); six infusions over two weeks in depressed inpatients with suicidal ideation.

Interventions

  • Ketamine0.5 mg/kg
    via IV• three times weekly for two weeks• 6 doses total

    0.5 mg/kg infused over 40 minutes; infusion may be slowed up to 90 minutes if needed.

  • Compound
    via Other• concomitant

    Treatment as usual (TAU) per site (antidepressant or mood stabiliser as clinically indicated).

Midazolam + TAU

active comparator

Active placebo (midazolam) plus TAU; same schedule as ketamine.

Interventions

  • Placebo0.045 mg/kg
    via IV• three times weekly for two weeks• 6 doses total

    Midazolam 0.045 mg/kg infused over 40 minutes (active placebo).

  • Compound
    via Other• concomitant

    Treatment as usual (TAU).

Participants

Ages
18 – 65
Sexes
Male & Female

Inclusion Criteria

  • Inclusion Criteria:
  • 1. Provision of written informed consent
  • 2. [MDD stream only] Diagnosis of major depressive disorder, currently depressed as determined by DSM-IV diagnostic criteria (confirmed using the MINI)
  • 3. [BD stream only] Diagnosis of bipolar disorder, type I or type II, currently depressed as determined by DSM-IV diagnostic criteria (confirmed using the MINI)
  • 4. Both females and males, aged 18 to 65 years
  • 5. Inpatient status
  • 6. Female patients of childbearing potential must have a negative urine hCG test at enrolment and must be taking or willing to take acceptable contraception during the study if sexually active
  • 7. Ability to understand and comply with study requirements and provide informed consent
  • 8. Suffering from suicidal ideation/attempts as evidenced by a score >0 on either the SSI or CSSRS or both.

Exclusion Criteria

  • Exclusion Criteria:
  • 1. Current or past psychotic symptoms
  • 2. Substance or alcohol dependence at enrollment (except dependence in full remission, and except for caffeine or nicotine dependence), as defined by DSM-IV criteria
  • 3. Opiates, amphetamine, barbiturate, cocaine, cannabis, or hallucinogen abuse by DSM-IV criteria within 4 weeks prior to enrollment
  • 4. Any pervasive developmental disorder (according to DSM-IV criteria)
  • 5. Diagnosis of dementia (according to DSM-IV criteria)
  • 6. Known intolerance or hypersensitivity to ketamine or midazolam as judged by the investigator
  • 7. Significant medical condition that would contraindicate ketamine/midazolam or that is untreated and would need urgent attention (as determined by treating physician)
  • 8. Medical conditions that would significantly affect absorption, distribution, metabolism, or excretion of ketamine or midazolam
  • 9. Unstable or inadequately treated medical illness (e.g., congestive heart failure, angina pectoris, hypertension) as judged by the investigator
  • 10. Any clinically significant deviation from the reference range in clinical laboratory test results as judged by the investigator
  • 11. Pregnancy (or female of child-bearing age not using adequate contraception) or lactation
  • 12. A positive β-hCG test at enrollment
  • 13. Involvement in the planning and conduct of the study
  • 14. Previous enrollment or randomisation in the present study
  • 15. Participation in another drug trial within 4 weeks prior to enrollment (or longer per local requirements)

Study Details

  • Status
    Completed
  • Phase
    Phase I
  • Type
    interventional
  • Design
    Randomizeddouble Blind
  • Target Enrollment9 participants
  • Timeline
    Start: 2016-01-01
    End: 2017-04-01
  • Compounds
    KetaminePlacebo
  • Topic
    Suicidality

Locations

Sunnybook Health Sciences Centre — Toronto, Ontario, Canada

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