drugset / Trial / NCT00550407

An Evaluation Of BW430C (Lamotrigine) Versus Placebo In The Prevention Of Mood Episodes In Bipolar I Disorder Patients

NCT00550407

Phase 3 Completed 215 enrolled GlaxoSmithKline
RandomizedParallel-groupDouble-blindTreatment

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.

Timeline

Start
2007-11
Primary completion
2009-10
Completion
2009-10

Publications

Drugs

EvaluationDrugModalityDoseRoute
Comparator Lamotrigine Small molecule 100 mg
Comparator Lamotrigine Small molecule 200 mg

Indications