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A Phase 2a, Randomized, Double-blind, Placebo-controlled Proof of Concept Study to Evaluate the Effects of Oral BTRX-335140 (NMRA-335140) Versus Placebo in Subjects With Major Depressive Disorder

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Trial Profile

A Phase 2a, Randomized, Double-blind, Placebo-controlled Proof of Concept Study to Evaluate the Effects of Oral BTRX-335140 (NMRA-335140) Versus Placebo in Subjects With Major Depressive Disorder

Status: Completed
Phase of Trial: Phase II

Latest Information Update: 20 Jul 2023

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At a glance

  • Drugs Navacaprant (Primary)
  • Indications Anhedonia; Major depressive disorder
  • Focus Proof of concept; Therapeutic Use
  • Sponsors BlackThorn Therapeutics; Neumora Therapeutics

    • Most Recent Events

    • 18 Jul 2023 According to Neumora Therapeutics media release, the company announced the positive End-of-Phase 2 meeting with U.S. Food and Drug Administration completed in June 2023
    • 18 Jul 2023 According to Neumora Therapeutics media release, The trial originally enrolled only mild-to-moderate MDD patients in the U.S., and Neumora subsequently amended the inclusion criteria to enroll patients with moderate-to-severe MDD.
    • 18 Jul 2023 Primary endpoint (Hamilton Depression Rating Scale (HAMD-17)) has not been met.

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