At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 215 enrolled
Drug / intervention
lamotrigine +1 moredrug
Likely dose
lamotrigine 100mgfrom 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.
Study SCA104779, an Evaluation of BW430C (Lamotrigine) Versus Placebo in the Prevention of Mood Episodes in Bipolar I Disorder Patients
In Brief
A Phase 3 clinical trial evaluating lamotrigine and Placebo for Bipolar Disorder. Completed, enrolled 215 participants across 60 sites.
Detailed Summary
This study is planned to objectively assess the efficacy and safety of lamotrigine maintenance therapy after symptoms of mood episode had been stabilised by open-label treatment with lamotrigine alone or in combination with other psychotropic medication in patients with bipolar I disorder.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBipolar Disorder
CountriesJapan
Collaborators--
Timeline
Phase 3CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedOct 2007
Enrollment StartNov 2007
Primary CompletionOct 2009
TodayJul 2026
First PostedOct 29, 2007
Enrollment StartNov 1, 2007
Primary CompletionOct 1, 2009
TodayJul 2, 2026
Enrollment to primary: 1.9 yearsPosted 18.7 years ago
Interventions
lamotriginedrug
lamotrigine 100mg/day or 200mg/day
Placebodrug
placebo once daily