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A Double-Blind, Placebo-Controlled, Parallel-Group, Fixed-Dosage 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
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 | 399 |
| Start date | 2011-03 |
| Completion | 2013-07 |
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, Argentina, Brazil, Bulgaria, Croatia, Finland, Germany, Hungary, Italy, Poland, Serbia, Slovakia, South Africa, Ukraine