A Double-Blind, Placebo-Controlled, Parallel-Group, Fixed-Dosage Study to Evaluate the Efficacy and Safety of Armodafinil Treatment (150 and 200 mg/Day) as Adjunctive Therapy in Adults With Major Depression Associated With Bipolar I Disorder

NCT01072929 Phase 3 COMPLETED Results posted

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.

Details

Lead sponsor	Cephalon
Phase	Phase 3
Status	COMPLETED
Enrolment	433
Start date	2010-01
Completion	2012-03

Conditions

• Depression

Interventions

• Armodafinil
• Placebo

Primary outcomes

• Change From Baseline to Week 8 in the Total Score From the 30-Item Inventory of Depressive Symptomatology-Clinician-Rated (IDS-C30) — Day 0 (baseline), Week 8
  The IDS-C30 is a standardized 30-item, clinician-rated scale to assess the severity of a participant's depressive symptoms. Every effort was made to have the same rater evaluate a participant across all visits. Total scores range from 0-84, with a score of 0 indicating no depression and a score of 84 indicating the most severe depression. Negative change from baseline values indicate improvement in the severity of depression.

Countries

United States