Efficacy and Safety of Eslicarbazepine Acetate (BIA 2-093) in Acute Manic Episodes Associated With Bipolar I Disorder
Status:
Completed
Trial end date:
2006-11-01
Target enrollment:
Participant gender:
Summary
Multicentre, double-blind, randomised, parallel-group, placebo-controlled dose-titration
study; depending on clinical efficacy, up-titration of dosage 3 and 6 days after start of
treatment; maintenance of individual maximum dose for the rest of the total 3-week treatment
period; subsequently, down-titration (according to the dose steps and the time intervals of
up-titration) and administration of an established anti-manic therapy during the tapering-off
period (in patients who discontinued treatment) or entry into a recurrence prevention study
(Protocol PRA+SCO/BIA-2093-205; reported under separate cover) as an option for patients who
responded to the study treatment