An Open-Label Extension Study Of Lamotrigine In Subjects With Bipolar Disorder
Trial overview
Number of participants with Serious Adverse Events (SAEs)
Timeframe: Up to 54 weeks
Participation 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
- 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.
- 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
- willing and able to give written informed consent to participate in the study.
male or female subject A female is eligible to enter and participate in this study if she is of: a)non-childbearing potential (i.e., physiologically incapable of becoming pregnant, including any female who is post-menopausal or sterilised) or, b)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.
- 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
Trial location(s)
Study documents
If you wish to request for full study report, please contact - [email protected]
Results overview
Results posted on ClinicalTrials.gov
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.