Efficacy and Safety of Eslicarbazepine Acetate (BIA 2-093) in Acute Manic Episodes Associated With Bipolar I Disorder
Condition: BIPOLAR I DISORDER
MeSH terms: Mania
Intervention: Eslicarbazepine acetate 1800 mg; Eslicarbazepine acetate 1200 mg; Eslicarbazepine acetate 600 mg; Placebo
Intervention description: Eslicarbazepine acetate to be taken orally, was available as 600 mg tablets.; Eslicarbazepine acetate to be taken orally, was available as 600 mg tablets.; Eslicarbazepine acetate to be taken orally, was available as 600 mg tablets.; Placebo sugar pills
Intervention MeSH terms: Eslicarbazepine acetate
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 38.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: BIPOLAR I DISORDER, Eslicarbazepine acetate

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 therapy in patients with acute mania. The secondary objectives of this study were
      to a) evaluate the safety and tolerability of eslicarbazepine acetate (BIA 2-093)
      administered at doses of 600, 1200, and 1800 mg compared with placebo, b) assess the duration
      to onset of action in the different dose groups, and c) monitor the appearance of depressive
      symptoms.
    

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.