At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 433 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 433 participants across 40 sites.
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
CountriesUnited States
Collaborators--
Timeline
Phase 3CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
Enrollment StartJan 2010
First PostedFeb 2010
Primary CompletionMar 2012
TodayJul 2026
First PostedFeb 22, 2010
Enrollment StartJan 1, 2010
Primary CompletionMar 1, 2012
TodayJul 2, 2026
Enrollment to primary: 2.2 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.