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.
Official Title
An Open-Label Extension Study to Assess the Safety of Lamotrigine in Subjects With Bipolar Disorder, Who Are in Remission Following a Manic/Hypomanic Index Episode or a Depressive Index Episode.
Conditions
Bipolar Disorder Type I and Type II
Study Type
Interventional
Study Design
Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety Study
Further Details
Primary Outcome Measures:
- Safety Safety will be evaluated on an ongoing basis during the scheduled visits, either in the clinic or by telephone.
Study Start
December 2005
Eligibility & Criteria
- Ages Eligible for Study: 18 Years and above
- Genders Eligible for Study: Both
Inclusion Criteria:
- completed 32 weeks of open label treatment in study SCA101469 and has responded to lamotrigine therapy
- female of non-childbearing potential or agrees to one of the specified contraceptive methods.
- willing and able to give written informed consent to participate in the study.
Exclusion 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
- known hypersensitivity to lamotrigine
- poses a current or recent serious suicidal or homicidal risk
- combination of carbamazepine and valproate or concurrent lamotrigine therapy
- current or history of substance abuse
- diagnosis of epilepsy or obsessive-compulsive disorder, social phobia, or eating disorder
- significant cardiac, renal, cerebrovascular, or hepatic condition
- unable to understand or implement instructions
- unresolved drug related adverse event or serious adverse event occurring in study SCA101469
Total Enrolment
15
Contact Details
- Greenwich, New South Wales, 2065, Australia
- Brisbane, Queensland, 4000, Australia
- Everton Park, Queensland, 4053, Australia
Contact GlaxoSmithKline for more information
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