A Phase 2a Proof-of-Concept Study of R-107 (Extended-Release Ketamine Tablets) for the Treatment of Refractory Major Depressive Disorder (BEDROC)

Randomized Placebo-Controlled Phase 2 Study of Extended-Release Ketamine Tablets (R-107) for Treatment-Resistant Depression - the BEDROC Study

In this phase 2 randomised, placebo‑controlled enrichment study, extended‑release oral ketamine tablets (R‑107) given twice weekly maintained antidepressant response in treatment‑resistant depression, with the 180 mg dose producing a significant 13‑week MADRS improvement versus placebo (least‑square mean difference −6.1, P = 0.019). R‑107 was generally well tolerated with minimal blood‑pressure, sedation or dissociation effects, showed a dose–response reduction in relapse rates, and most dosing was performed at home.

Published

June 24, 2024

Journal

Nature Medicine

Authors

Glue, P., Loo, C., Fam, J., Lane, H. Y., Young, A., Surnam, P.