Status:
TERMINATED
Efficacy and Safety of Eslicarbazepine Acetate (BIA 2-093) in Acute Manic Episodes Associated With Bipolar I Disorder
Lead Sponsor:
Bial - Portela C S.A.
Conditions:
BIPOLAR I DISORDER
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The primary study objective was to evaluate the dose-dependent efficacy of eslicarbazepine acetate administered at doses of 600, 1200, and 1800 mg over a 3-week period, compared with placebo, as thera...
Detailed Description
This was a phase II, double-blind, fixed multiple dose, randomised, placebo-controlled, multicentre clinical trial in patients with a diagnosis of bipolar I disorder who experienced an acute manic (in...
Eligibility Criteria
Inclusion
- Aged 18 years or more.
- A documented diagnosis of bipolar I disorder according to the Diagnostic and Statistical Manual of Mental Disorders, 4th Edition (DSM-IV) criteria (i.e., 296.0, 296.4 or 296.6).
- Currently displaying an acute manic (including mixed) episode according to the DSM-IV criteria.
- A Young Mania Rating Scale (YMRS) total score of 20 or greater.
- Symptoms of the current manic episode starting within 2 weeks prior to Randomization (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 (PSV).
Exclusion
- History of schizophrenia or schizoaffective disorder, psychotic features or rapid cycling.
- Currently treated with carbamazepine or oxcarbazepine.
- History of unresponsiveness, intolerance or hypersensitivity to related compounds (carbamazepine, oxcarbazepine or licarbazepine).
- Use of any depot-neuroleptics for the current manic episode
- Abuse of stimulating drugs or use of any systemic sympathicomimetic drug 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.
- Judged clinically 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 \[men: (140-age) x weight / serum creatinine x 72; women: (0.85) (140-age) x weight / serum creatinine x 72. Age in years, weight in kg, and serum creatinine in mg/dl\].
- 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.
Key Trial Info
Start Date :
February 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2006
Estimated Enrollment :
38 Patients enrolled
Trial Details
Trial ID
NCT01824602
Start Date
February 1 2006
End Date
November 1 2006
Last Update
March 27 2014
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