At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 399 enrolled
Drug / intervention
Armodafinil +1 moredrug
Likely dose
Not stated in 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 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 399 participants across 130 sites in 14 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, Brazil, Bulgaria, Croatia, Finland, Germany, Hungary, Italy, Poland, Serbia, Slovakia, South Africa, Ukraine, United States
Collaborators--
Timeline
Phase 3CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedFeb 2011
Enrollment StartMar 2011
Primary CompletionJul 2013
TodayJul 2026
First PostedFeb 28, 2011
Enrollment StartMar 1, 2011
Primary CompletionJul 1, 2013
TodayJul 2, 2026
Enrollment to primary: 2.3 yearsPosted 15.3 years ago
Interventions
Armodafinildrug
Armodafinil tablets, taken orally, once daily in the morning
Placebodrug
Matching placebo tablets, taken orally, once daily in the morning