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 TRIA
- Conditions
- Acute manic episodes associated with bipolar I disorder in a double-blind, randomised, dose-titration, placebo-controlled, multicentre clinical trial
- Registration Number
- EUCTR2005-002131-27-PT
- Lead Sponsor
- Bial - Portela & Cª, S.A.
- 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 (V2, Day 1); 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.
Concomitant medication: Patients currently treated with bipolar disorder preventive medication (for carbamazepine or oxcarbazepine see exclusion criteria) or antidepressants must be washed-out for at least two days prior to Randomization (V2, Day 1). Patients can only get randomized with lithium plasma levels < 0.5 mmol/L or valproic acid plasma level < 50 mg/L. Benzodiazepines should be permitted on the following lorazepam (or equivalent) doses: Dose ? 8 mg/day in Week 1, Dose ? 4 mg/day in Week 2 and Dose ? 2 mg/day in Week 3, but not within 4 hours before YMRS assessment.
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
Patients 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 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