A Phase 2, Randomized, Double-blind, Placebo-controlled Study to Evaluate ALKS 5461 in Subjects With Major Depressive Disorder and Inadequate Response to Antidepressant Therapy.

Trial Profile

A Phase 2, Randomized, Double-blind, Placebo-controlled Study to Evaluate ALKS 5461 in Subjects With Major Depressive Disorder and Inadequate Response to Antidepressant Therapy.

Completed
Phase of Trial: Phase II

Latest Information Update: 01 May 2016

At a glance

  • Drugs Buprenorphine/samidorphan (Primary)
  • Indications Major depressive disorder
  • Focus Therapeutic Use
  • Sponsors Alkermes plc
  • Most Recent Events

    • 18 Jul 2013 The company will review phase II data of this drug at its Research and Development (R&D) Day meeting for analysts and investors in July 2013.
    • 17 Apr 2013 Top line interim results published in an Alkermes media release.
    • 17 Apr 2013 Primary endpoint 'significant change in Hamilton-Depression-Rating-Scale vs placebo' has been met, according to an Alkermes media release.
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