An Open-Label Extension Study Of Lamotrigine In Subjects With Bipolar Disorder
Condition: Bipolar Disorder
MeSH terms: Bipolar Disorder
Intervention: lamotrigine
Intervention MeSH terms: Lamotrigine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 11.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Lamictal; lamotrigine; Open-Label Extension Study; Bipolar Disorder

Summary:

      The precursor study (SCA101469) was an open-label, prospective multicentre study in adult
      subjects diagnosed with bipolar disorder consisting of 36 weeks treatment with lamotrigine.
      The current study is to provide 12 months post study access to open-label lamotrigine for
      participants of the SCA101469 study.
    

Eligibility criteria:

        Inclusion Criteria:

        A subject will be eligible for inclusion in this study only if all of the following
        criteria apply:

          -  completed 32 weeks of open label treatment in study SCA101469 and, in the
             investigators opinion, has responded to lamotrigine therapy

          -  male or female subject

        A female is eligible to enter and participate in this study if she is of:

          1. non-childbearing potential (i.e., physiologically incapable of becoming pregnant,
             including any female who is post-menopausal or sterilised) or,

          2. child-bearing potential, has a negative urine pregnancy test at screening, and agrees
             to one of the following contraceptive methods:

               -  Complete abstinence from intercourse from 2 weeks prior to administration of the
                  study drug, throughout the study, and for a time interval after completion of
                  premature discontinuation from the study to account for elimination of the
                  investigational drug (a minimum of 5 half-lives or longer if the pharmacodynamic
                  profile of the investigational drug warrants a longer time period); or,

               -  Sterilisation of male partner; or,

               -  Implants of levonorgestrel; or,

               -  Injectable progestogen; or,

               -  Oral contraceptive (combined or progestogen only); or,

               -  Any intrauterine device (IUD) with published data showing that the lowest
                  expected failure rate is less than 1% per year (not all IUDs meet this
                  criterion); or,

               -  Any other methods with published data showing that the lowest expected failure
                  rate for that method is less than 1% per year; or,

               -  Barrier method only if used in combination with any of the above acceptable
                  methods.

                    -  willing and able to give written informed consent to participate in the
                       study.

        Exclusion Criteria:

        A subject will not be eligible for inclusion in this study if any of the following criteria
        apply:

          -  subject experienced a 'mood episode' during participation in study SCA101469, or since
             completing participation in study SCA101469.

          -  participation in a clinical drug trial other than SCA101469 within the past 30 days or
             previous participation in this clinical study

          -  known hypersensitivity to lamotrigine

          -  in the investigator's judgement, the subject poses a current serious suicidal or
             homicidal risk, or has made a suicide attempt within the past 6 months.

          -  combination of carbamazepine and valproate

          -  concurrent lamotrigine therapy, other than that commenced in study SCA101469

          -  current or history of substance abuse

          -  diagnosis of epilepsy

          -  diagnosis or history of an obsessive-compulsive disorder, social phobia, or eating
             disorder

          -  significant cardiac, renal, cerebrovascular, or hepatic condition; no significant
             abnormalities in the laboratory tests or ECG recording performed during study
             SCA101469.

          -  unable to understand or implement instructions

          -  unresolved drug related adverse event or serious adverse event occurring in study
             SCA101469