A Clinical Evaluation Of BW430C (Lamotrigine) In Bipolar I Disorder- Long-term Extension Of Study SCA104779 (NCT00550407) -
Condition: Bipolar Disorder
MeSH terms: Bipolar Disorder
Intervention: BW430C (lamotrigine)
Intervention description: lamotrigine 50mg/day-400mg/day
Intervention MeSH terms: Lamotrigine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 92.0
Sex: All
Minimum age: 20 Years
Healthy volunteers: No
Keywords: Open-label extension; Tolerability; Lamotrigine; Safety; Bipolar I disorder

Summary:

      This study is planned to assess the long-term safety of lamotrigine in Japanese patients with
      bipolar I disorder who will continue into the 52-week extension upon completion of a
      double-blind comparative study (Study No.: SCA104779 (NCT00550407)), i.e. the patients who
      receive the addition of any additional treatment to intervene in a mood episode in the
      double-blind phase or the patients completing the double-blind phase.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Of subjects participating in the preceding double-blind study, those who are judged by
             the investigator/sub-investigator to have well tolerated the double-blind treatment
             and to be eligible for the 52-week extension treatment

          -  Sex: either sex. Female of child-bearing potential will be eligible for inclusion in
             this study. However they have to have a negative pregnancy test at the start of this
             study, agree to further pregnancy testing at the time points determined in study
             assessments and procedures and practice one of the following methods of contraception
             from the start of this study until the end of the follow-up examination:

        Abstinence

        Oral contraceptive, either combined or progestogen alone (except during the Dosage
        Adjustment Phase)

        Injectable progestogen

        Implants of levonorgestrel

        Estrogenic vaginal ring (except during the Dosage Adjustment Phase)

        Percutaneous contraceptive patches (except during the Dosage Adjustment Phase)

        Intrauterine device (IUD) or intrauterine system (IUS) that meets the SOP effectiveness
        criteria as stated in the product label

        Male partner sterilization (vasectomy with documentation of azoospermia) prior to the
        female subject's entry into the study, and this male is the sole partner for that subject

        Double barrier method: condom or occlusive cap (diaphragm or cervical / vault caps) plus
        spermicidal agent (foam / gel / film / cream / suppository)

          -  In/Out patient: Either

          -  Informed consent: the subject capable of giving written informed consent

        Exclusion Criteria:

          -  Has a score of 3 or more on item of the HAM-D related to suicide or is at a high
             suicidal risk in the judgment of the investigator/sub-investigator

          -  Has a history of severe rash or rash due to anti-epileptic drugs

          -  Patients with severe hepatic/renal/cardiac/pulmonary disorder or hematopoietic
             disorder. The severity refers to Grade 3 according to "the Classification of the
             Severity of Adverse Experiences" (PAB/SD Notification No. 80, dated 29 June 1992)

          -  Patients have less than 5 years of remission history from clinically significant
             malignancy (other than e.g. basal cell or squamous cell skin cancer, in-situ carcinoma
             of cervix or prostate CA in situ)

          -  Patients with chronic hepatitis typeB and /or typeC which is positive of hepatitis B
             surface antigen （HBsAg）and/or hepatitis C antibody

          -  Has an acute or chronic illness likely to impair drug absorption, distribution,
             metabolism or excretion or has any unstable physical symptoms likely to require
             hospitalisation during participation in the study

          -  Female patients who are pregnant or lactating, who may be pregnant, or who plan for
             pregnancy during the study

          -  Has a history or current diagnosis of epilepsy

          -  Has received an investigational drug within 30 days of screening

          -  Patients with a history of drug allergy to any ingredient of the test-drug

          -  Patients whom the investigator or sub-investigator considers ineligible for the study