A Phase 3 Efficacy and Safety Study of ALKS 5461 for the Adjunctive Treatment of Major Depressive Disorder

Trial Profile

A Phase 3 Efficacy and Safety Study of ALKS 5461 for the Adjunctive Treatment of Major Depressive Disorder

Completed
Phase of Trial: Phase III

Latest Information Update: 11 May 2017

At a glance

  • Drugs Buprenorphine/samidorphan (Primary)
  • Indications Major depressive disorder
  • Focus Registrational; Therapeutic Use
  • Acronyms FORWARD-4
  • Sponsors Alkermes plc
  • Most Recent Events

    • 11 May 2017 According to an Alkermes media release, pooled data from FORWARD-4 and FORWARD-5 will be presented at the Society of Biological Psychiatry (SOBP) Annual Meeting.
    • 03 Feb 2016 Status changed from active, no longer recruiting to completed as reported by ClinicalTrials.gov.
    • 21 Jan 2016 Primary endpoint (Change from baseline in the MRDRS score) has not been met, according to an Alkermes plc media release.
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