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A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Trial of the Safety and Efficacy of Two Fixed Doses of OPDC-34712 as Adjunctive Therapy in the Treatment of Adults With Major Depressive Disorder, the Polaris Trial

Trial Profile

A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Trial of the Safety and Efficacy of Two Fixed Doses of OPDC-34712 as Adjunctive Therapy in the Treatment of Adults With Major Depressive Disorder, the Polaris Trial

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 05 Sep 2023

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At a glance

  • Drugs Brexpiprazole (Primary) ; Antidepressants
  • Indications Major depressive disorder
  • Focus Registrational; Therapeutic Use
  • Acronyms Polaris
  • 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
    • 19 Sep 2022 Results of post-hoc analysis (NCT01360645, NCT01360632, NCT02196506 & NCT01727726) assessing the effects of adjunctive brexpiprazole on different symptom clusters in major depressive disorder, published in the Journal of Affective Disorders.
    • 05 Oct 2021 Results of pooled and post hoc analysis from NCT01360645, NCT01360632, NCT02196506 assessing whether baseline level of functioning moderates the benefits of adjunctive brexpiprazole on life engagement, presented at the 34th Annual Congress of the European College of Neuropsychopharmacology
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