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A Phase 3b Efficacy and Safety Study of Adjunctive ALKS 5461 in Treatment Refractory Major Depressive Disorder

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Trial Profile

A Phase 3b Efficacy and Safety Study of Adjunctive ALKS 5461 in Treatment Refractory Major Depressive Disorder

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 09 Apr 2021

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At a glance

  • Drugs Buprenorphine/samidorphan (Primary)
  • Indications Major depressive disorder
  • Focus Registrational; Therapeutic Use
  • Sponsors Alkermes plc

    • Most Recent Events

    • 15 Mar 2021 Results published in the ClinicalTrials.gov Trial Registry
    • 15 Mar 2021 Primary endpoint (Change From Baseline to the End of Treatment (EOT) in the Montgomery Asberg Depression Rating Scale-10 (MADRS-10) Scores) has not been met as per results published in the ClinicalTrials.gov Trial Registry
    • 27 Mar 2020 Status changed from active, no longer recruiting to completed.

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