Trial PaperDepressive DisordersMajor Depressive Disorder (MDD)Treatment-Resistant Depression (TRD)Healthy VolunteersSafety & Risk ManagementKetamine

Intravenous arketamine for treatment-resistant depression: open-label pilot study

This open-label study (n=7) study investigated the antidepressant efficacy of (R-)ketamine (35mg/70kg), which has been implicated by animal studies to be more potent and longer-lasting compared to (S-)ketamine. Results demonstrate (R-)ketamine's ability to produce a fast and robust antidepressant effect in patients with depression, with potentially greater and longer-lasting effects, greater response rate, and a lower remission rate than effects reported for (S-)ketamine, although this study had a small sample size and lacked placebo-control.

Authors

  • Gerard Sanacora
  • Colleen Loo
  • Kenji Hashimoto

Published

European Archives of Psychiatry and Clinical Neuroscience
individual Study

Abstract

Introduction

We aimed to analyze the efcacy and safety of arketamine, the R(−)-enantiomer of ketamine, for treatment-resistant depression (TRD) in humans.

Methods

Open-label pilot trial, seven subjects with TRD received a single intravenous infusion of arketamine (0.5 mg/kg); primary outcome was change in Montgomery-Åsberg Depression Rating Scale (MADRS) 24 h after.

Results

Mean MADRS dropped from 30.7 before infusion to 10.4 after one day, a mean diference of 20.3 points [CI 95% 13.6-27.0; p<0.001]; dissociation was nearly absent.

Discussion

Arketamine might produce fast-onset and sustained antidepressant efects in humans with favorable safety profle, like previously reported with animals; further controlled-trials are needed.

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Research Summary of 'Intravenous arketamine for treatment-resistant depression: open-label pilot study'

Introduction

Over the past two decades, ketamine and its S(+)-enantiomer esketamine have been shown to produce rapid antidepressant effects in major depressive disorder (MDD), including in patients with treatment-resistant depression (TRD). Wider clinical use has been constrained by concerns about abuse potential, psychotomimetic and cardiovascular side-effects, and relatively short duration of benefit. Preclinical work has suggested that the R(-)-enantiomer of ketamine, arketamine, may produce more potent and longer-lasting antidepressant effects than either racemic ketamine or esketamine and with fewer psychotomimetic effects; limited human data from anaesthetic use and a small healthy volunteer study also suggested a favourable safety profile. Leal and colleagues therefore undertook an exploratory human study to evaluate whether a single intravenous infusion of arketamine produces rapid antidepressant effects in TRD and to characterise its acute safety and dissociative profile. The investigation is presented as a first-in-humans clinical evaluation of arketamine's antidepressant action in this population and intended to inform future controlled trials.

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Study Details

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References (9)

Papers cited by this study that are also in Blossom

Antidepressant effects of ketamine in depressed patients

Berman, R. M., Cappiello, A., Anand, A. et al. · Biological Psychiatry (2000)

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Correia-Melo, F. S., Argolo, F. C., Araújo-de-Freitas, L. et al. · Neuropsychiatric Disease And Treatment (2017)

Ketamine administration in depressive disorders: a systematic review and meta-analysis

Fond, G., Loundou, A., Macgregor, A. et al. · Psychopharmacology (2014)

Antidepressant Efficacy of Ketamine in Treatment-Resistant Major Depression: A Two-Site Randomized Controlled Trial

Murrough, J. W., Iosifescu, D. V., Chang, L. C. et al. · American Journal of Psychiatry (2013)

R (−)-ketamine shows greater potency and longer lasting antidepressant effects than S (+)-ketamine

Zhang, J., Hashimoto, K., Li, S. · Pharmacology Biochemistry and Behavior (2014)

R-ketamine: a rapid-onset and sustained antidepressant without psychotomimetic side effects

Yang, C., Shirayama, Y., Zhang, J-C. et al. · Translational Psychiatry (2020)

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Dawson, K., May, A., Carangan, J. M. et al. · MedRvix (2024)

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Rodgers, A., Bahceci, D., Davey, C. G. et al. · Australian and new-zealand Journal of Psychiatry (2023)

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