Conditions: Depression
Keywords: Bipolar I Disorder
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 867
Healthy volunteers: no

Brief summary:
The primary objective of this study is to evaluate the safety and tolerability of long term (6 months) armodafinil treatment as adjunctive therapy to mood-stabilizing medications in adults with bipolar I disorder.

Detailed description:

Arms:
arm 1: 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. At the discretion of the investigator, the dosage of armodafinil may be increased to 200 mg/day on day 6 or thereafter, and reduced to 150mg/day if the higher dose is not well tolerated. Treatment was administered for six months.

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

Protocol document: