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.
Minimum age: 18 Years.
Maximum age: N/A.
A subject will be eligible for inclusion in this study only if all of the following
- 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
- 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
- willing and able to give written informed consent to participate in the
A subject will not be eligible for inclusion in this study if any of the following criteria
- 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
- significant cardiac, renal, cerebrovascular, or hepatic condition; no significant
abnormalities in the laboratory tests or ECG recording performed during study
- unable to understand or implement instructions
- unresolved drug related adverse event or serious adverse event occurring in study