drugset / Trial / NCT01121536

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

NCT01121536

Phase 3 Terminated 867 enrolled Cephalon
NaSingle-groupOpen-labelTreatment

Summary

The primary objective of this study is to evaluate the safety and tolerability of long term (6 months) armodafinil treatment as adjunctive therapy to mood-stabilizing medications in adults with bipolar I disorder.

Timeline

Start
2010-04-30
Primary completion
2013-10-31
Completion
2013-10-31

Drugs

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

Indications