Conditions: Depression
Keywords: Bipolar I Disorder
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 492
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 were administered placebo and titrated to match the armodafinil treatment arms. Total treatment was 8 weeks. arm 2: Participants started the study at a dose of 50mg/day of armodafinil and titrated up in the first week to 150 mg/day. The 150 mg/day dosage was continued for 7 more weeks for a total of 8 weeks of treatment. arm 3: Participants started the study at a dose of 50mg/day of armodafinil and titrated up in the first week to 200 mg/day. The 200 mg/day dosage was continued for 7 more weeks for a total of 8 weeks of treatment. This treatment arm was discontinued via a protocol amendment.

Interventions: intervention 1: Armodafinil intervention 2: Placebo
Intervention descriptions: intervention 1: Doses of either 150mg/day or 200 mg/day in tablet form taken orally, once daily in the morning. intervention 2: Matching Placebo, also in tablet form taken orally, once daily in the morning.

Protocol document: