an open-label extension study of lamotrigine in subjects with bipolar disorder

Conditions: 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

Keywords: lamictal lamotrigine open-label extension study bipolar disorder