NCT01121536

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

A 6-Month, Open-Label, Flexible-Dosage (150 to 200 mg/Day) Extension Study of the Safety and Efficacy of Armodafinil Treatment as Adjunctive Therapy in Adults With Major Depression Associated With Bipolar I Disorder

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 867 (actual)
• Sponsor: Cephalon · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The primary objective of this study is to evaluate the safety and tolerability of long term (6 months) armodafinil treatment as adjunctive therapy to mood-stabilizing medications in adults with bipolar I disorder.

Conditions

• Depression

Interventions

Type	Name	Description
DRUG	Armodafinil	Armodafinil tablets, taken orally, once daily in the morning

Timeline

• Start date: 2010-04-30
• Primary completion: 2013-10-31
• Completion: 2013-10-31
• First posted: 2010-05-12
• Last updated: 2018-09-21
• Results posted: 2015-01-26

Locations

158 sites across 17 countries: United States, Argentina, Australia, Brazil, Bulgaria, Canada, Croatia, France, Germany, Hungary, Italy, Poland, Serbia, Slovakia, South Africa, Spain, Ukraine