At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 492 enrolled
Drug / intervention
Armodafinil +1 moredrug
Likely dose
Armodafinil 150mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 3 clinical trial evaluating Armodafinil and Placebo for Depression. Completed, enrolled 492 participants across 92 sites in 10 countries.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDepression
CountriesArgentina, Australia, Bulgaria, Canada, France, Poland, South Africa, Spain, Ukraine, United States
Collaborators--
Timeline
Phase 3CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedFeb 2010
Enrollment StartMar 2010
Primary CompletionNov 2012
TodayJul 2026
First PostedFeb 22, 2010
Enrollment StartMar 1, 2010
Primary CompletionNov 1, 2012
TodayJul 2, 2026
Enrollment to primary: 2.7 yearsPosted 16.4 years ago
Interventions
Armodafinildrug
Doses of either 150mg/day or 200 mg/day in tablet form taken orally, once daily in the morning.
Placebodrug
Matching Placebo, also in tablet form taken orally, once daily in the morning.