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A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Trial of the Safety and Efficacy of Fixed-dose Brexpiprazole (OPC-34712) as Adjunctive Therapy in the Treatment of Adults With Major Depressive Disorder With and Without Anxious Distress

Trial Profile

A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Trial of the Safety and Efficacy of Fixed-dose Brexpiprazole (OPC-34712) as Adjunctive Therapy in the Treatment of Adults With Major Depressive Disorder With and Without Anxious Distress

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 01 Oct 2019

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At a glance

  • Drugs Brexpiprazole (Primary)
  • Indications Major depressive disorder
  • Focus Registrational; Therapeutic Use
  • Acronyms Sirius
  • Sponsors Otsuka Pharmaceutical Development & Commercialization
  • Most Recent Events

    • 01 Oct 2019 Results of pooled analysis assessing the effect of adjunctive brexpiprazole on metabolic parameters and body weight in adults with major depressive disorder using pooled data from 4 short-term studies and 1 long-term extension study (NCT01360645, NCT01360632, NCT02196506, NCT01727726, NCT01360866) published in the Journal of Clinical Psychiatry
    • 02 Dec 2018 Results of post-hoc analysis determining the effect of adjunctive brexpiprazole using pooled data from six randomized studies (NCT01360645, NCT01360632, NCT02196506, NCT01727726, NCT00797966, NCT01052077) published in the International Journal of Neuropsychopharmacology
    • 22 May 2018 Results published in the Journal of Clinical Psychiatry
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