Oral extended-release ketamine shows dose-related benefit in resistant depression

This phase 2 trial provides the first randomized evidence that an extended-release oral ketamine tablet (R-107) can maintain antidepressant response with markedly less dissociation, sedation, and blood pressure change than parenteral or intranasal ketamine.

ketamineR-107esketamineextended-release oral ketaminetreatment-resistant depressionmajor depressive disorderNMDA receptor antagonistphase 2 trialrelapse preventionenrichment designpsychopharmacology Psychiatry / Psychopharmacology

Background Information

Oral ketamine tablets offer new hope for treatment-resistant depression.

Treatment-resistant depression (TRD) is challenging to manage, and an oral formulation of ketamine could offer a new approach with better safety and tolerability. The study found a significant improvement in depression scores with the 180 mg dose of extended-release ketamine, with a least square mean difference of -6.1 compared to placebo at 13 weeks. The study supports the use of extended-release ketamine tablets in TRD, showing both efficacy and good tolerability, with minimal side effects such as sedation and dissociation. Extended-release ketamine tablets show promise for treating TRD with manageable side effects.

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Authors: Glue P, Loo C, Fam J, Lane HY, Young AH, Surman P, BEDROC study investigators

Citation: Glue P, Loo C, Fam J, et al. Extended-release ketamine tablets for treatment-resistant depression: a randomized placebo-controlled phase 2 trial. Nature medicine. 2024;30(7):2004-2009. doi:10.1038/s41591-024-03063-x

Article Links: PubMed · Journal / DOI · Free Full Text (PMC)

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