At a glance
ClinicalIndex Comparison RecordPhase 4Completed· 11 enrolled
Drug / intervention
lamotriginedrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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.
In Brief
A Phase 4 clinical trial evaluating lamotrigine for Bipolar Disorder. Completed, enrolled 11 participants across 3 sites.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBipolar Disorder
CountriesAustralia
Collaborators--
Timeline
Phase 4CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartOct 2005
First PostedAug 2006
Primary CompletionFeb 2007
TodayJul 2026
First PostedAug 3, 2006
Enrollment StartOct 1, 2005
Primary CompletionFeb 1, 2007
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 19.9 years ago
Interventions
lamotriginedrug