Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 3:53 AM
Ignite Modification Date:
2025-12-25 @ 3:53 AM
NCT ID:
NCT01824602
Eligibility Criteria:
Inclusion Criteria:
* 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 Criteria:
* 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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01824602
Study Brief:
Protocol Section:
NCT01824602