Efficacy and Safety of Eslicarbazepine Acetate (BIA 2-093) in Acute Manic Episodes Associated With Bipolar I Disorder
Status:
Terminated
Trial end date:
2006-11-01
Target enrollment:
Participant gender:
Summary
The primary study objective was to evaluate the dose-dependent efficacy of eslicarbazepine
acetate administered at doses of 600, 1200, and 1800 mg over a 3-week period, compared with
placebo, as therapy in patients with acute mania. The secondary objectives of this study were
to a) evaluate the safety and tolerability of eslicarbazepine acetate (BIA 2-093)
administered at doses of 600, 1200, and 1800 mg compared with placebo, b) assess the duration
to onset of action in the different dose groups, and c) monitor the appearance of depressive
symptoms.