Clinical TrialParallelPlaceboKetamineKetamineKetamineKetamineCompleted

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.

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

Study Arms & Interventions

Placebo

placebo

Double-blind placebo administered twice weekly for 12 weeks

Interventions

  • Placebo0 mg
    via oral• twice weekly

    Administered as tablets

R-107 30mg

experimental

Double-blind R-107 30 mg administered twice weekly for 12 weeks

Interventions

  • Ketamine30 mg
    via Oral• twice weekly

    Extended-release tablets (R-107)

R-107 60mg

experimental

Double-blind R-107 60 mg administered twice weekly for 12 weeks

Interventions

  • Ketamine60 mg
    via Oral• twice weekly

    Extended-release tablets (R-107)

R-107 120mg

experimental

Double-blind R-107 120 mg administered twice weekly for 12 weeks

Interventions

  • Ketamine120 mg
    via Oral• twice weekly

    Extended-release tablets (R-107)

R-107 180mg

experimental

Double-blind R-107 180 mg administered twice weekly for 12 weeks

Interventions

  • Ketamine180 mg
    via Oral• twice weekly

    Extended-release tablets (R-107)

Study Protocol, Arms & Participants

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Study Details

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

Related Publications

Open AccessindividualPrimary

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
Journal
Nature Medicine
Authors
Glue, P., Loo, C., Fam, J., Lane, H. Y., Young, A., Surnam, P.

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