drugset / Trial / NCT00566020

A Clinical Evaluation Of BW430C (Lamotrigine) In Bipolar I Disorder- Long-term Extension Of Study SCA104779 (NCT00550407) -

NCT00566020

Phase 3 Completed 92 enrolled GlaxoSmithKline
Non-randomizedSingle-groupOpen-labelTreatment

Summary

This study is planned to assess the long-term safety of lamotrigine in Japanese patients with bipolar I disorder who will continue into the 52-week extension upon completion of a double-blind comparative study (Study No.: SCA104779 (NCT00550407)), i.e. the patients who receive the addition of any additional treatment to intervene in a mood episode in the double-blind phase or the patients completing the double-blind phase.

Timeline

Start
2008-05
Primary completion
2010-10
Completion
2010-10

Publications

  • Background Tsukasa Koyama, Teruhiko Higuchi, Shigeto Yamawaki, Shigenobu Kanba, Takeshi Terao and Atsuko Shinohara. Study SCA106052, a clinical evaluation of BW430C (lamotrigine) in bipolar I disorder - Long-term extension study -. Rinsho seishin igaku. 2011;40(7):981-995.

Drugs

EvaluationDrugModalityDoseRoute
Subject Lamotrigine Small molecule 50 mg
Subject Lamotrigine Small molecule 400 mg

Indications