EFFICACY AND SAFETY OF ESLICARBAZEPINE ACETATE (BIA 2-093) IN ACUTE MANIC EPISODES ASSOCIATED WITH BIPOLAR I DISORDER IN A DOUBLE-BLIND, FIXED MULTIPLE DOSE, RANDOMIZED, PLACEBO-CONTROLLED, MULTICENTRE CLINICAL TRIA
- Conditions
- Patients with acute manic episodes fulfilling DSM-IV criteria for Bipolar I Disorder.
- Registration Number
- EUCTR2005-002133-13-ES
- 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
Patients must be/have:
1. Aged 18 years or more.
2. A documented diagnosis of bipolar I disorder according to the DSM-IV criteria (i.e. 296.0, 296.4 or 296.6).
3. Currently displaying an acute manic (including mixed) episode according to the DSM-IV criteria.
4. A Young Mania Rating Scale (YMRS) total of 20 or greater.
5. Symptoms of current manic episode starting within 2 weeks prior to randomization(V2, Day 1).
6. Able to undergo a standard evaluation, including clinical interview, ratings and laboratory studies.
7. Signed informed consent form (ICF).
8. Post-menopausal or otherwise incapable of becoming pregnant by reason of surgery or tubal ligation. In case of a 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 (PSV).
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
1. History of schizophrenia or schizoaffective disorder, psychotic features or rapid cycling.
2. Currently treated with carbamazepine or oxcarbazepine.
3. History of unresponsiveness, intolerance or hypersensitivity to related compounds (carbamazepine, oxcarbazepine or licarbazepine).
4. Use of any depot-neuroleptics for the current manic episode.
5. Abuse of stimulating drugs of use of any systemic sympathicomimetic drug within the previous 2 weeks.
6. Electroconvulsive therapy (ECT) within the previous 3 months.
7. History of dependence or chronic abuse from alcohol, drugs or medications within the last year.
8. Judged clinically to be at risk of harm to others.
9. Second or third-degree atrioventricular blockade not corrected with a pacemaker.
10. Relevant ECG or laboratory abnormalities.
11. Calculated creatinine clearance <30 ml/min [see Protocol for further details].
12. Pregnancy or nursing.
13. Participation in other drug clinical trial within the last 2 months before Randomization visit.
14. Not ensured capability to perform the trial or to comply with the study protocol (e.g. mental retardation or severe inability to communicate).
15. Any other uncontrolled clinically relevant disorder.
16. Previous treatment with Eslicarbazepine Acetate
There is also a description of Prohibited and Allowed Therapy during the Study Period.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To evaluate the dose-dependent efficacy of Eslicarbazepine Acetate administered at once-daily doses of 600 mg, 1200 mg and 1800 mg over a 3-week period compared with placebo as therapy in patients with acute mania.;Secondary Objective: To evaluate the safety and tolerability of Eslicarbazepine Acetate compared with placebo; to assess the duration to onset of action; to monitor the appearance of depressive symptomatology.;Primary end point(s): Change in Young Mania Rating Scale (YMRS) total score from baseline until the end of the 3 week treatment period.
- Secondary Outcome Measures
Name Time Method