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

Outcome

Outcome not reported

Stopped (Business): “Business decision related to efficacy rather than tolerability limitations, not stopped for any safety reasons.”

Drugs

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

Indications