March 17, 2009
Phase 2 study of Nuvigil for bipolar depressionCephalon announced positive results from a phase 2 clinical trial of Nuvigil (armodafinil) tablets as adjunctive therapy for treating major depressive disorder in adults with bipolar I disorder.
The eight-week, double-blind, placebo-controlled study evaluated the efficacy and safety of Nuvigil (150 mg/day) as an adjunctive therapy to mood stabilizers in 257 patients with bipolar I disorder, who experienced a major depressive episode that was not completely managed by their other treatments. Patients in the study taking Nuvigil as adjunctive therapy showed improvement of depressive symptoms (p=0.042) as measured on the primary endpoint - the 30-Item Inventory of Depressive Symptomatology, Clinician-Rated (IDS-C30) scale. The IDS-C30 scale is an instrument used to evaluate depressive episodes and associated symptoms.
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