EFFICACY AND SAFETY OF ESLICARBAZEPINE ACETATE (BIA 2-093) IN ACUTE MANIC EPISODES ASSOCIATED WITH BIPOLAR I DISORDER IN A DOUBLE-BLIND, RANDOMISED, DOSE-TITRATION, PLACEBO-CONTROLLED, MULTICENTRE CLINICAL TRIAL - NA
- Conditions
- Acute manic episodes associated with bipolar I disoder in a double-blind, randomised, dose-titration, placebo- controlled, multicentre clinical trial
- Registration Number
- EUCTR2005-002131-27-CZ
- Lead Sponsor
- BIAL - Portela & Cª, SA
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 160
Patient must be/ have
-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?
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
Patient must not be/have
-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)
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method