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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 Depr...

Mise à jour : Il y a 4 ans
Référence : EUCTR2009-016667-11

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

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Extrait

The primary objective of the study is to determine whether armodafinil treatment, at dosages of 150 and 200 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. Efficacy will be assessed by the mean change from baseline 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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