Lamictal Bipolar Observational Study
This study has been completed.
Information provided by (Responsible Party):
First received: April 12, 2007
Last updated: March 15, 2012
Last verified: January 2011
This is multi-center, prospective, observational stud. This study is designed to evaluate the rate of non-serious rash in Korean bipolar I patients.
|Study Design:||Time Perspective: Prospective|
|Official Title:||A Multi-centre, Observational Study to Evaluate the Incidence of Non-serious Rash in Korean Bipolar I Patients With Lamotrigine Therapy in Real World Setting|
Resource links provided by NLM:
U.S. FDA Resources
Further study details as provided by GlaxoSmithKline:
Primary Outcome Measures:
- Occurrence of non-serious rash during 12 weeks of treatment with lamotrigine in patients with bipolar I in Korea [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- CGI-BP at Week 12 and occurrence of adverse events at Week 12 [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
|Study Start Date:||March 2007|
|Study Completion Date:||December 2007|
|Primary Completion Date:||December 2007 (Final data collection date for primary outcome measure)|
there is only one group.
lamotrigine treatment for 12weeks
Contacts and Locations