drugset / Trial / NCT01072630

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

NCT01072630

Phase 3 Completed 492 enrolled Cephalon
RandomizedParallel-groupQuadruple-blindTreatment

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.

Timeline

Start
2010-03
Primary completion
2012-11
Completion
2012-11

Drugs

EvaluationDrugModalityDoseRoute
Subject Armodafinil Small molecule 150 mg Oral
Subject Armodafinil Small molecule 200 mg Oral

Indications