Study to Evaluate the Efficacy and Safety of Armodafinil Treatment (150 mg/Day) as Adjunctive Therapy in Adults With Major Depression Associated With Bipolar I Disorder

Phase 3 Completed 399 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: 2011-03
Primary completion: 2013-07
Completion: 2013-07

Outcome

Missed primary endpoint

paper The primary efficacy outcome did not reach statistical significance; PMID 26330288 ↗

registry Placebo vs Armodafinil 150 mg/Day; p = 0.2717; Mean Difference (Final Values) -1.4 (95% CI -3.76 to 1.06) NCT01305408 ↗

release “While study 3072 demonstrated a numerical improvement, it did not reach statistical significance in meeting its primary endpoint” tevapharm.com ↗

Publications

Frye MA, Amchin J, Bauer M, Adler C, Yang R, Ketter TA. Randomized, placebo-controlled, adjunctive study of armodafinil for bipolar I depression: implications of novel drug design and heterogeneity of concurrent bipolar maintenance treatments. Int J Bipolar Disord. 2015 Dec;3(1):34. doi: 10.1186/s40345-015-0034-0. Epub 2015 Sep 2.

Drugs

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