A Double-Blind, Placebo-Controlled, Parallel-Group, Fixed-Dosage Study to Evaluate the Efficacy and Safety of Armodafinil Treatment (150 and 200 mg/Day) as Adjunctive Therapy in Adults With Major Depression Associated With Bipolar I Disorder.

Trial Profile

A Double-Blind, Placebo-Controlled, Parallel-Group, Fixed-Dosage Study to Evaluate the Efficacy and Safety of Armodafinil Treatment (150 and 200 mg/Day) as Adjunctive Therapy in Adults With Major Depression Associated With Bipolar I Disorder.

Completed
Phase of Trial: Phase III

Latest Information Update: 29 Apr 2016

At a glance

  • Drugs Armodafinil (Primary)
  • Indications Bipolar I disorders
  • Focus Registrational; Therapeutic Use
  • Sponsors Cephalon
  • Most Recent Events

    • 22 May 2013 Baseline data presented at the 18th Annual International Meeting of the International Society for Pharmacoeconomics and Outcomes Research.
    • 23 Jan 2013 Positive results that were statistically significant had been reported in May 2012 according to a Teva Pharmaceutical Industries media release.
    • 06 May 2012 Planned number of patients changed from 400 to 660 as reported by European Clinical Trials Database.
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