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A Phase 3, Randomized, Double-blind Study to Evaluate the Safety and Tolerability of Two Titration Schedules for ALKS 5461 for the Adjunctive Treatment of Major Depressive Disorder in Adults With an Inadequate Response to Antidepressant Therapy (the FORWARD-1 Study)

Trial Profile

A Phase 3, Randomized, Double-blind Study to Evaluate the Safety and Tolerability of Two Titration Schedules for ALKS 5461 for the Adjunctive Treatment of Major Depressive Disorder in Adults With an Inadequate Response to Antidepressant Therapy (the FORWARD-1 Study)

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 16 Aug 2019

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At a glance

  • Drugs Buprenorphine/samidorphan (Primary)
  • Indications Major depressive disorder
  • Focus Adverse reactions; Registrational
  • Acronyms FORWARD-1
  • Sponsors Alkermes
  • Most Recent Events

    • 16 Jun 2015 Results will be presented at the American Society of Clinical Psychopharmacology (ASCP) Annual Meeting 2015, according to an Alkermes media release.
    • 09 Oct 2014 Status changed from active, no longer recruiting to completed as reported by ClinicalTrials.gov.
    • 07 Aug 2014 Status changed from recruiting to active, no longer recruiting as reported by ClinicalTrials.gov record.
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