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.
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
- 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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Table of Contents
- At a glance
- Trial Overview
- Trial Details
- Trial Centres
- Trial History