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”

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 Type: Observational

Study Design: Prospective

Study Primary Completion Date: December 2007

Intervention(s) in this Clinical Trial

• Drug: Lamotrigine

Primary Measures

• Occurrence of adverse events after ropinirole administration

Secondary Measures

• Occurrence of unexpected adverse events after ropinirole administration Occurrence of serious adverse events after ropinirole administration Improvement assessment according to the investigator's medical judgement

Inclusion criteria:

• A subject will be eligible for inclusion in this study only if all of the following criteria apply:
• Provides written informed consent
• Male or female age 18 years or older A female subject is eligible to enter and participate in the study if she is of;
• Non-childbearing potential
• Childbearing potential, has a negative pregnancy test at screen
• Diagnosis of bipolar I disorder using DSM-IV criteria

Exclusion criteria:

• A subject will not be eligible for inclusion in this study if any of the following criteria apply:
• Previous or current treatment with lamotrigine
• Presence of a clinically significant psychiatric or physiologic comorbidity, including significant substance abuse, severe depression or mania which is of an unstable or progressive nature that could, in the opinion of the investigator, interfere with participation in this study
• Presence of untreated thyroid disease
• Have active suicidality or homicidality, history of recent suicide attempts within the past year, or, in the investigator's opinion, a marked risk for suicide
• History of severe hepatic or renal insufficiency or significant hematologic disease or other significant medical or psychiatric condition that would interfere with subjects' participation in the study
• Currently participating in another clinical trial, or plans to enroll in another trial while participating in this study
• Currently pregnant or is breastfeeding

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: GlaxoSmithKline

Overall Clinical Trial Officials and Contacts

GSK Clinical Trials, MD Study Director GlaxoSmithKline  

Information obtained from ClinicalTrials.gov on November 20, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00460226

Study ID Number: LBI108245

ClinicalTrials.gov Identifier: NCT00460226

Health Authority: Korea: Food and Drug Administration