Conditions: Depression
Keywords: Bipolar I Disorder
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 399
Healthy volunteers: no

Brief summary:
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.

Detailed description:

Arms:
arm 1: Participants began taking placebo to match armodafinil and following the same titration procedure. Treatment was administered for a total of 8 weeks. arm 2: Participants began taking armodafinil at a dosage of 50 mg/day; the dosage was increased by 50 mg/day on days 2 and 4, up to a dosage of 150 mg/day. Treatment was administered for a total of 8 weeks.

Interventions: intervention 1: Armodafinil intervention 2: Placebo
Intervention descriptions: intervention 1: Armodafinil tablets, taken orally, once daily in the morning intervention 2: Matching placebo tablets, taken orally, once daily in the morning

Protocol document: