NCT01305408

Study to Evaluate the Efficacy and Safety of Armodafinil Treatment (150 mg/Day) 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 mg/Day) as Adjunctive Therapy in Adults With Major Depression Associated With Bipolar I Disorder

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 399 (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	Armodafinil tablets, taken orally, once daily in the morning
DRUG	Placebo	Matching placebo tablets, taken orally, once daily in the morning

Timeline

• Start date: 2011-03-01
• Primary completion: 2013-07-01
• Completion: 2013-07-01
• First posted: 2011-02-28
• Last updated: 2016-05-26
• Results posted: 2015-01-26

Locations

130 sites across 14 countries: United States, Argentina, Brazil, Bulgaria, Croatia, Finland, Germany, Hungary, Italy, Poland, Serbia, Slovakia, South Africa, Ukraine