Lamictal Bipolar Observational Study

Completed

• Conditions: Bipolar Disorder
• Interventions: Drug: lamotrigine

• Registration Number: NCT00460226
• Lead Sponsor: GlaxoSmithKline

Brief Summary

This is multi-center, prospective, observational stud. This study is designed to evaluate the rate of non-serious rash in Korean bipolar I patients.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-03
• Study First Submitted: 2007-04-12
• Study First Submitted QC: 2007-04-12
• Study First Posted: 2007-04-13
• Primary Completion: 2007-12
• Study Completion: 2007-12
• Status Verified: 2011-01
• Last Update Submitted: 2012-03-15
• Last Update Posted: 2012-03-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 238

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
lamotrigine	lamotrigine	there is only one group.

Primary Outcome Measures

Name	Time	Method
Occurrence of non-serious rash during 12 weeks of treatment with lamotrigine in patients with bipolar I in Korea	12 weeks

Secondary Outcome Measures

Name	Time	Method
CGI-BP at Week 12 and occurrence of adverse events at Week 12	12 weeks