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A Long-term, Phase 3, Multicenter, Open-label Trial to Evaluate the Safety and Tolerability of Oral OPC-34712 as Adjunctive Therapy in Adults With Major Depressive Disorder, the Orion Trial

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Trial Profile

A Long-term, Phase 3, Multicenter, Open-label Trial to Evaluate the Safety and Tolerability of Oral OPC-34712 as Adjunctive Therapy in Adults With Major Depressive Disorder, the Orion Trial

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 05 Sep 2023

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At a glance

  • Drugs Brexpiprazole (Primary) ; Duloxetine; Escitalopram; Fluoxetine; Paroxetine; Sertraline; Venlafaxine
  • Indications Major depressive disorder
  • Focus Adverse reactions; Registrational
  • Acronyms Orion
  • Sponsors Otsuka Pharmaceutical Development & Commercialization

    • Most Recent Events

    • 28 Aug 2023 Results of pooled analysis from (NCT01360645, NCT01360632, NCT02196506, and NCT01360866) assessing effect of adjunctive brexpiprazole on metabolic parameters and body weight in adults with MDD and prediabetes published in the Journal of Clinical Psychiatry
    • 01 Nov 2020 Results of pooled analysis from three short-term clinical studies: NCT01360645, NCT01360632, NCT02196506 and long-term studies: NCT01360866 published in the Journal of Clinical Psychopharmacology
    • 15 Sep 2020 Results (n=1547) of post hoc analysis of completion rates in long-term studies (Orion; NCT01360866 and aripiprazole study (NCT00095745)) assessing completion rates and reasons for discontinuation among patients treated with adjunctive brexpiprazole or adjunctive aripiprazole in MDD, presented at the 33rd Annual Congress of the European College of Neuropsychopharmacology
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