Clinical TrialCrossoverKetaminePlaceboCompleted

Effects of single intravenous arketamine dose as an adjunctive therapy for treatment-resistant unipolar depression: a randomized, double-blind, crossover, placebo-controlled trial

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Target Enrollment
10 participants
Study Type
Design
Randomized, double Blind

Study Protocol

Preparation

sessions

Dosing

2 sessions
40 min each

Integration

sessions

Study Arms & Interventions

Arketamine

experimental

Arketamine 0.5 mg/kg administered intravenously over 40 minutes.

Interventions

  • Ketamine0.5 mg/kg
    via IV• single dose per crossover period• 1 doses total

    Pure (R)-ketamine hydrochloride, enantiomeric excess >99.0%; each participant received arketamine in one of two crossover periods.

Placebo

inactive

Saline placebo administered intravenously over 40 minutes.

Interventions

  • Placebo
    via IV• single dose per crossover period• 1 doses total

    Saline placebo; each participant received placebo in one of two crossover periods.

Study Protocol, Arms & Participants

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Study Details

  • Status
    Completed
  • Design
    Randomizeddouble Blind
  • Target Enrollment10 participants
  • Timeline
    Start: 2020-01-24
    End: 2021-12-13
  • Compounds
    KetaminePlacebo

Related Publications

PaywallindividualPrimary

Arketamine as adjunctive therapy for treatment-resistant depression: A placebo-controlled pilot study

This double-blind, cross-over study (n=10) finds that arketamine (35mg/70kg, the 'right-handedness of ketamine) isn't superior to placebo, but does find it to be safe in a population with treatment-resistant depression (TRD).

Published
Journal
Journal of Affective Disorders
Authors
Leal, G. C.

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