Patients with acute manic episode fulfilling DSM-IV criteria for Bipolar I Disorder (i.e., 296.0, 296.4 or 296.6)
Conditions
Sponsors
BIAL - Portela & Ca, S.A.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 18 years or more; DSM-IV criteria for Bipolar I Disorder (i.e., 296.0, 296.4 or 296.6) and for current acute manic (including mixed) episode; YMRS total score = 20; symptoms of current manic episode starting within 2 weeks prior to Randomisation; able to undergo a standard evaluation including clinical interview, ratings and laboratory studies; signed informed consent form (ICF); post-menopausal or otherwise incapable of becoming pregnant by reason of surgery or tubal ligation; in case of woman of childbearing potential, patient presents a serum pregnancy test consistent with a non-gravid state and will use double-barrier contraception until at least the post-study visit Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: history of schizophrenia or schizoaffective disorder; psychotic features; history of rapid cycling; currently treated with carbamazepine or oxcarbazepine; history of unresponsiveness, intolerance or hypersensitivity to related compounds (carbamazepine, oxcarbazepine or licarbazepine); use of depot-neuroleptics in the current manic episode; abuse of stimulating drugs or use of systemic sympathicomimetic drugs within the previous 2 weeks; electroconvulsive therapy (ECT) within the previous 3 months-history of dependence or chronic abuse from alcohol, drugs or medications within the last year; clinically judged to be at risk of harm to self or others; second or third-degree atrioventricular blockade not corrected with a pacemaker; relevant ECG or laboratory abnormalities; calculated creatinine clearance < 30 mL/min; pregnancy or nursing; participation in other drug clinical trial within the last 2 months before randomization visit; not ensured capability to perform the trial or to comply with the study protocol (e.g. mental retardation or severe inability to communicate); any other uncontrolled clinically relevant disorder; previous treatment with study drug Eslicarbazepine acetate (BIA 2-093)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the dose-dependent efficacy of two dose titration regimens of Eslicarbazepine Acetate compared with placebo as therapy in patients with acute mania.;Secondary Objective: To evaluate the safety and tolerability of two dose titration regimens of Eslicarbazepine Acetate in comparison to placebo.;Primary end point(s): Change in the YMRS score at the end of the 3-week treatment period, in the relation to the baseline | — |
Countries
Austria, Czech Republic, Germany, Portugal
Outcome results
None listed