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Effects of single intravenous arketamine dose as... — Clinical Trial Details | Blossom

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

Registry

Other / UMIN000038347

Study Protocol

Preparation

sessions

Dosing

2 sessions

40 min each

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: June 1, 2023
Journal: Journal of Affective Disorders
Authors: Leal, G. C.

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 Details

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