A 12-week, Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Trial of Aripiprazole Intramuscular Depot (OPC-14597, Lu AF41155) in the Acute Treatment of Adults With Schizophrenia

Trial Profile

A 12-week, Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Trial of Aripiprazole Intramuscular Depot (OPC-14597, Lu AF41155) in the Acute Treatment of Adults With Schizophrenia

Completed
Phase of Trial: Phase III

Latest Information Update: 05 Apr 2017

At a glance

  • Drugs Aripiprazole (Primary)
  • Indications Schizophrenia
  • Focus Registrational; Therapeutic Use
  • Sponsors Otsuka Pharmaceutical Development & Commercialization
  • Most Recent Events

    • 05 Apr 2017 Results (n=329) of post hoc analysis assessing the efficacy of AOM 400 in improving the PANSS Marder factors, published in the Journal of Clinical Psychopharmacology
    • 03 Feb 2016 Results published in Lundbeck A/S media release.
    • 03 Feb 2016 According to Lundbeck A/S media release, company announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion for a type-II variation related to the update of the European summary of the product characteristics (SmPC) for Abilify Maintena. The application was submitted to the European Medicines Agency (EMA) and the assessment started end November 2015.
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