Clinical TrialMajor Depressive Disorder (MDD)KetaminePlaceboCompleted

Ketamine Trial for the Treatment of Depression

Randomised, triple-blind, parallel Phase I trial (n=10) comparing ketamine versus placebo for patients with major depressive disorder and inadequate response to antidepressants.

Target Enrollment
10 participants
Study Type
Phase I interventional
Design
Randomized, triple Blind

Detailed Description

Randomised, triple-masked, parallel-group Phase I study enrolling 10 participants with major depressive disorder (MADRS ≥ 20) and prior inadequate response to at least two antidepressants to compare ketamine with placebo.

Primary purpose is treatment; outcomes and safety assessments follow trial protocol. Eligible and exclusion criteria address psychiatric history, suicide risk, substance use, and contraindications to ketamine.

Study Arms & Interventions

Ketamine

experimental

Active ketamine treatment arm.

Interventions

  • Ketamine

    Drug: Ketamine

Placebo

inactive

Placebo comparator arm.

Interventions

  • Placebo

    Drug: Placebo

Participants

Ages
16 – 99
Sexes
Male & Female

Inclusion Criteria

  • Major depressive disorder for at least three months duration
  • Inadequate response to at least 2 adequate antidepressants
  • MADRS ≥ 20
  • Age ≥ 16 years (16-17 require parental consent)

Exclusion Criteria

  • History of psychosis
  • History of bipolar disorder
  • Any unstable medical or neurologic condition
  • Any Axis I disorder other than MDD judged to be the primary presenting problem
  • Planned major changes to psychotropic medication
  • Significant risk of suicide
  • Planned or probable use of ECT
  • Age under 16 years, or 16-17 years without parental consent
  • Substance abuse or dependence in previous 6 months
  • Any history of abuse of ketamine or phencyclidine
  • Contraindication to the use of ketamine
  • Planned use of ketamine
  • Women of childbearing potential not taking reliable contraception
  • Likely non-compliance with trial treatment
  • Other condition judged by the treating clinician as likely to impact on the ability of the participant to complete the trial

Study Details

Locations

Brain & Mind Research Institute (BMRI), University of Sydney — Camperdown, New South Wales, Australia
Black Dog Institute, University of New South Wales — Sydney, New South Wales, Australia

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