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

2010-03

Primary completion

2012-11

Completion

2012-11

Outcome

Missed primary endpoint

registry Placebo vs Armodafinil 150 mg/Day; p = 0.1302; Mean Difference (Final Values) -2.1 (95% CI -4.67 to 0.60) NCT01072630 ↗

paper numerically superior for adjunctive armodafinil 150 mg/day vs adjunctive placebo, but was not statistically significant (p=0.13). PMID 25933099 ↗

Publications

• Ketter TA, Yang R, Frye MA. Adjunctive armodafinil for major depressive episodes associated with bipolar I disorder. J Affect Disord. 2015 Aug 1;181:87-91. doi: 10.1016/j.jad.2015.04.012. Epub 2015 Apr 15.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Armodafinil	Small molecule	150 mg	Oral
Subject	Armodafinil	Small molecule	200 mg	Oral

Indications