NCT00481195

Armodafinil Treatment as Adjunctive Therapy in Adults With Major Depression Associated With Bipolar I Disorder

An 8 Week Double Blind, Placebo-Controlled, Parallel Group, Fixed Dosage Study to Evaluate the Efficacy and Safety of Armodafinil Treatment (150mg/Day) as Adjunctive Therapy in Adults With Major Depression Associated With Bipolar I Disorder

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 257 (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 if armodafinil treatment, at a dosage of 150 mg/day, is more effective than placebo treatment as adjunctive therapy for adults who are experiencing a major depressive episode associated with Bipolar I Disorder and who are inadequately responsive to their current treatment for a current major depressive episode.

Conditions

• Bipolar I Depression

Interventions

Type	Name	Description
DRUG	Armodafinil	Patients were randomly assigned to begin oral treatment with armodafinil, which was titrated to 150 mg/day (3 tablets). Armodafinil was titrated up to the target dosage of 150 mg/day (daily dose was administered each morning). Patients began taking blinded armodafinil at a dose of 50 mg/day (1 tablet) on the day following the baseline visit. Doses were increased by 50 mg/day (1 tablet) to a dose of 100 mg/day on Day 2 and 3, and then again by 50 mg /day on day 4 for a target dose of 150 mg/day. Following titration, patients continued taking 150 mg/day of armodafinil for the duration of the study. If a patient was unable to tolerate (recurrent or persistent adverse events) the study drug, 1 reduction in dosage (ie, minimum dosage 100 mg/day \[2 tablets\]) was allowed. The dosage could not be increased after it was decreased.
DRUG	Placebo	Patients were randomly assigned to begin oral treatment with placebo, which was titrated to 3 tablets. Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets. Study drug was titrated up to the target dosage of 3 tablets / day (daily dose was administered each morning). Patients began taking blinded study drug at a dose of 1 tablet daily on the day following the baseline visit. Doses were increased by 1 tablet to a dose of 2 tablets/day on Day 2 and 3, and then again by 1 tablet /day on day 4 for a target dose of 3 tablets/day. Following titration, patients continued taking 3 tablets/day of study drug for the duration of the study. If a patient was unable to tolerate (recurrent or persistent adverse events) the study drug, 1 reduction in dosage (ie, minimum dosage 2 tablets/day) was allowed. The dosage could not be increased after it was decreased.

Timeline

• Start date: 2007-06-01
• Primary completion: 2008-12-01
• Completion: 2008-12-01
• First posted: 2007-06-01
• Last updated: 2013-07-19
• Results posted: 2010-12-20

Locations

55 sites across 4 countries: United States, Bulgaria, Hungary, Romania