Lamictal Bipolar Observational Study

Bipolar Disorder Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00460226
• Other study ID #: LBI108245
• Status: Completed
• Phase: N/A
• First received: April 12, 2007
• Last updated: March 15, 2012
• Start date: March 2007
• Est. completion date: December 2007

Study information

• Verified date: January 2011
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 238
• Est. completion date: December 2007
• Est. primary completion date: December 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Time Perspective: Prospective

Related Conditions & MeSH terms

• Bipolar Disorder

Intervention

Drug:
• lamotrigine
lamotrigine treatment for 12weeks

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Occurrence of non-serious rash during 12 weeks of treatment with lamotrigine in patients with bipolar I in Korea		12 weeks	Yes
Secondary	CGI-BP at Week 12 and occurrence of adverse events at Week 12		12 weeks	Yes