Status:
COMPLETED
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
Multicentre, double-blind, randomised, parallel-group, placebo-controlled dose-titration study; depending on clinical efficacy, up-titration of dosage 3 and 6 days after start of treatment; maintenanc...
Detailed Description
Objectives: The primary objective was to evaluate the dose-dependent efficacy of 2 dose-titration regimens of Eslicarbazepine Acetate (ESL) compared with placebo as therapy in patients with acute man...
Eligibility Criteria
Inclusion
- aged ≥18 years;
- 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) \[8\];
- currently displaying an acute manic (including mixed) episode according to the DSM-IV criteria;
- a Young Mania Rating Scale (YMRS) total score of ≥20;
- symptoms of the 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;
- post-menopausal or otherwise incapable of becoming pregnant by reason of surgery or tubal ligation; women of childbearing potential had to present a serum pregnancy test consistent with a non-gravid state and had to use double-barrier contraception until the post-study visit (PSV).
Exclusion
- a history of schizophrenia or schizoaffective disorder, psychotic features or rapid cycling;
- currently treated with carbamazepine or oxcarbazepine;
- a 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 within the previous 3 months;
- a 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 electrocardiogram (ECG) or laboratory abnormalities;
- calculated creatinine clearance \<30 mL/min \[men: (140-age) x weight / serum creatinine x 72; women: (0.85) (140-age) x weight / serum creatinine x 72. Age in years, weight in kg, and serum creatinine in mg/dL\];
- pregnant or nursing;
- participating in another drug clinical trial within the last 2 months before the randomisation 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;
- a history or presence of bone marrow impairment or depression (introduced by protocol amendment No. 1);
- a history or presence of acute intermittent porphyria (introduced by protocol amendment No. 1).
- Patients receiving treatment for bipolar disorder or other central nervous system disorders at randomisation were excluded from randomisation. If the patients had previously used such medications the following restrictions had to be taken into account:
- Patients treated with bipolar disorder preventive medication (for carbamazepine or oxcarbazepine see exclusion criteria), antidepressants, antipsychotic, anxiolytic, antiparkinsonian, and/or other potentially centrally acting drugs had to be washed-out for at least 2 days prior to randomisation (V2, Day 1).
- Patients treated with lithium or valproate could only be randomised with plasma levels \< 0.5 mmol/L and \< 50 mg/L, respectively.
Key Trial Info
Start Date :
December 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2006
Estimated Enrollment :
161 Patients enrolled
Trial Details
Trial ID
NCT01822678
Start Date
December 1 2005
End Date
November 1 2006
Last Update
March 27 2014
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