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An 8-Week, 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 Dep...

Mise à jour : Il y a 4 ans
Référence : EUCTR2007-007555-14

An 8-Week, 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

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Extrait

The primary objective of the study is to determine if armodafinil treatment, at a dosage of 150 mg/day, is more effective than placebo treatment as adjunctive therapy for adults who are experiencing a major depressive episode associated with Bipolar I Disorder and who are inadequately responsive to their current treatment for a current major depressive episode. This will be assessed by the change from baseline to endpoint in the total score from the 30-Item Inventory of Depressive Symptomatology-Clinician-Rated (IDS-C30).

Critère d'inclusion

  • Major Depression Associated With Bipolar I Disorder

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