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

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

2010-01

Primary completion

2012-03

Completion

2012-03

Outcome

Met primary endpoint

registry analysis (superiority or other test); Placebo vs Armodafinil 150 mg/Day; p = 0.0097; Mean Difference (Final Values) -3.8 (95% CI -6.58 to -0.92); NCT01072929 ↗

Publications

• Results Calabrese JR, Frye MA, Yang R, Ketter TA; Armodafinil Treatment Trial Study Network. Efficacy and safety of adjunctive armodafinil in adults with major depressive episodes associated with bipolar I disorder: a randomized, double-blind, placebo-controlled, multicenter trial. J Clin Psychiatry. 2014 Oct;75(10):1054-61. doi: 10.4088/JCP.13m08951.

Drugs

Indications