Clinical TrialSuicidalityKetamineRecruiting

Understanding and Treating Suicidal Ideation With Ketamine

This open-label, Phase II/III trial (n=36) will study the effects of ketamine (0.5 mg/kg IV infused over 40 minutes, four infusions over two weeks) on suicidal ideation in individuals with major depressive disorder (MDD).

Target Enrollment
36 participants
Study Type
Phase II/III interventional
Design
Non-randomized

Detailed Description

Prospective, open-label single-group study delivering four intravenous ketamine infusions (0.5 mg/kg over 40 minutes) administered twice weekly across two weeks to participants with MDD and active suicidal ideation.

Primary outcomes assess change in suicidal ideation and associated clinical scales; neurobiological mechanisms are examined using advanced diffusion MRI pre-treatment and 24 hours after the fourth infusion.

A mixed-methods approach includes repeated clinical assessments and brief qualitative interviews within 72 hours post-treatment to capture patient-perceived changes in suicidal thinking; target sample size informed by diffusion MRI effect-size considerations.

Study Protocol

Preparation

sessions

Dosing

4 sessions
40 min each

Integration

sessions

Study Arms & Interventions

Ketamine

experimental

Open-label single-group treatment: four IV ketamine infusions over two weeks.

Interventions

  • Ketamine0.5 mg/kg
    via IV• twice weekly• 4 doses total

    0.5 mg/kg infused over 40 minutes; four infusions over two weeks.

Participants

Ages
18 – 65
Sexes
Male & Female

Inclusion Criteria

  • Inclusion Criteria:
  • 1. English speaking
  • 2. Ages 18-65 years old
  • 3. Suicidal ideation severity score ≥3 on the Columbia Suicide Severity Rating Scale (C-SSRS) (Baseline/Screening version) at Screening Visit (active suicidal ideation with any methods)
  • 4. Diagnosis of Major Depressive Disorder (MDD) according to DSM-5
  • 5. Willing to maintain stable doses of concomitant medications throughout the study
  • 6. Be under the care of a designated health care provider (e.g., family physician or psychiatrist) to follow their care after the completion of the study.

Exclusion Criteria

  • Exclusion Criteria:
  • 1. Participants not medically cleared to receive ketamine treatment due to presence of clinically relevant disease (e.g., uncontrolled hypertension, renal or hepatic impairment, significant coronary artery disease, diabetes mellitus, seizure disorder).
  • 2. Known or suspected hypersensitivity or intolerance to ketamine
  • 3. Body mass index (BMI) ≥35
  • 4. History of a primary psychotic disorder (e.g., schizophrenia), or current or recent (<2 years) acute episode of psychosis
  • 5. Current and/or recent history (<12 months) of substance use/dependence (except for caffeine or nicotine) or problematic current alcohol use or dependence as defined by DSM-5 criteria
  • 6. Pregnant, breastfeeding or of childbearing potential and unwilling to use an approved method of contraception during the study
  • 7. History of significant head injury including loss of consciousness >5 minutes
  • 8. Any MRI contraindications
  • 9. Concurrent use of ketamine in any form
  • 10. Concurrent active ECT or repetitive transcranial magnetic stimulation (rTMS) therapy

Study Details

  • Status
    Recruiting
  • Phase
    Phase IIPhase III
  • Type
    interventional
  • Design
    Non-randomized
  • Target Enrollment36 participants
  • Timeline
    Start: 2025-04-08
    End: 2026-10-01
  • Compound
    Ketamine
  • Topic
    Suicidality

Locations

Royal Ottawa Mental Health Centre — Ottawa, Ontario, Canada

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