Lamictal Bipolar Observational Study

NCT ID: NCT00460226

Last Updated: 2012-03-19

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 238 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2007-03-31
• Study Completion Date: 2007-12-31

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.

Conditions

Bipolar Disorder

Study Design

• Study Time Perspective: PROSPECTIVE

Study Groups

lamotrigine

there is only one group.

lamotrigine

Intervention Type: DRUG

lamotrigine treatment for 12weeks

Interventions

lamotrigine

lamotrigine treatment for 12weeks

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

GlaxoSmithKline

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

References

Woo YS, Bahk WM, Jon DI, Joo YH, Kim W, Seo JS, Ahn YM, Chung SK, Won SH, Shin YC, Yoon BH, Jung SH, Seok JH, Lee YS, Kim Y, Min KJ. Rash in adult patients receiving lamotrigine to treat bipolar I disorder in Korea: a multicenter, prospective, naturalistic, open-label trial. Prog Neuropsychopharmacol Biol Psychiatry. 2009 Oct 1;33(7):1147-52. doi: 10.1016/j.pnpbp.2009.06.010. Epub 2009 Jun 18.

Reference Type: BACKGROUND

PMID: 19540298 (View on PubMed)

Other Identifiers

LBI108245

Identifier Type: -

Identifier Source: org_study_id