Clinical trial NCT01824602 (phase 2, status: terminated)
Conditions: bipolar i disorder
ICD codes: F31.70, F31.71, F31.72, F31.73, F31.74, F31.75, F31.76
Drugs: eslicarbazepine acetate 1800 mg, eslicarbazepine acetate 1200 mg, eslicarbazepine acetate 600 mg, placebo
SMILES: CC(=O)O[C@H]1CC2=CC=CC=C2N(C(N)=O)C2=CC=CC=C12, CC(=O)O[C@H]1CC2=CC=CC=C2N(C(N)=O)C2=CC=CC=C12, CC(=O)O[C@H]1CC2=CC=CC=C2N(C(N)=O)C2=CC=CC=C12, CN1C(=O)C=C(N2CCC[C@@H](N)C2)N(CC2=C(C=CC=C2)C#N)C1=O
Reason stopped: 
    due to a slow recruitment rate
  
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.