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

    • 23 Jan 2013 Top-line results have been reported in a Teva Pharmaceutical Industries media release.
    • 23 Jan 2013 Primary objective of demonstrating statistically significant improvement of armodafinil 150 mg/day vs placebo, as assessed with the 'Inventory-of-Depressive-Symptomatology' (primary endpoint) has not been met.
    • 01 Jan 2013 Status changed from recruiting to completed as reported by ClinicalTrials.gov.
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