An Open-Label Extension Study Of Lamotrigine In Subjects With Bipolar Disorder

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.