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

BIAL - Portela & Ca, S.A.0 个研究点目标入组 160 人开始时间: 2005年9月21日最近更新: 2022年4月19日

研究概览

暂无简介。

•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.

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