Clinical TrialCompleted

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

BEDROC: Phase 2a proof-of-concept two-part study of R-107, an extended-release ketamine tablet, in treatment-resistant MDD. Part 1: open-label R-107 120 mg/day × 5 days (~200 screened). Part 2: responders randomized to placebo or R-107 (30/60/120/180 mg) twice-weekly for 12 weeks (target 150). Primary outcome: MADRS change from baseline to Day 92. Sponsor: Douglas Pharmaceuticals Ltd. Sites: Australia, New Zealand, Singapore, Taiwan.

Target Enrollment
200 participants
Study Type
Phase II interventional
Design
Randomized, double Blind

Study Details

  • Status
    Completed
  • Phase
    Phase II
  • Type
    interventional
  • Design
    Randomizeddouble Blind
  • Target Enrollment200 participants
  • Timeline
    Start: 2019-05-30
    End: 2021-08-27

Related Publications

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

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

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