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Extended-release ketamine tablets for treatment-resistant depression: a randomized placebo-controlled phase 2 trial

Medicine and Health

Extended-release ketamine tablets for treatment-resistant depression: a randomized placebo-controlled phase 2 trial

P. Glue, C. Loo, et al.

This multicenter trial by Paul Glue and colleagues explored the effectiveness of extended-release ketamine tablets (R-107) for treatment-resistant major depression. Results showed significant improvement in depressive symptoms, particularly in the 180 mg group, while maintaining excellent tolerability. Experience minimal side effects like headaches and dizziness, and discover how R-107 is paving a new path in depression treatment.

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Playback language: English
Abstract
This phase 2 multicenter clinical trial investigated the efficacy and safety of extended-release ketamine tablets (R-107) in treating treatment-resistant major depression (TRD). 329 patients were screened, 231 entered an open-label enrichment phase (120 mg R-107 daily for 5 days), and 168 responders were randomized to double-blind treatment (placebo, 30, 60, 120, or 180 mg R-107 twice weekly for 12 weeks). The primary endpoint (least square mean change in MADRS at 13 weeks) was met; the 180 mg group showed a statistically significant improvement compared to placebo (-6.1, 95% CI 1.0 to 11.16, P=0.019). Relapse rates showed a dose response (70.6% placebo to 42.9% 180 mg). Tolerability was excellent, with minimal sedation and dissociation. The most common adverse events were headache, dizziness, and anxiety. R-107 tablets were effective, safe, and well-tolerated in this enriched TRD population.
Publisher
Nature Medicine
Published On
Jul 01, 2024
Authors
Paul Glue, Colleen Loo, Johnson Fam, Hsien-Yuan Lane, Allan H. Young, Peter Surman
Tags
ketamine
treatment-resistant depression
clinical trial
efficacy
safety
adverse events
relapse rates
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