NCT01072929

A Study to Evaluate the Efficacy and Safety of Armodafinil Treatment as Adjunctive Therapy in Adults With Major Depression Associated With Bipolar I Disorder

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 433 (actual)
• Sponsor: Cephalon · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The primary objective of the study is to determine whether armodafinil treatment, at a dosage of 150 mg/day, is more effective than placebo treatment as adjunctive therapy to mood stabilizers for treatment of adults with major depression associated with bipolar I disorder.

Conditions

• Depression

Interventions

Type	Name	Description
DRUG	Armodafinil	Doses of either 150mg/day or 200 mg/day in tablet form taken orally, once daily in the morning.
DRUG	Placebo	Matching Placebo, also in tablet form taken orally, once daily in the morning.

Timeline

• Start date: 2010-01-01
• Primary completion: 2012-03-01
• Completion: 2012-03-01
• First posted: 2010-02-22
• Last updated: 2016-04-27
• Results posted: 2015-01-26

Locations

40 sites across 1 country: United States