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Lamictal Bipolar Observational Study

Information source: GlaxoSmithKline
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Bipolar Disorder

Intervention: lamotrigine (Drug)

Phase: N/A

Status: Completed

Sponsored by: GlaxoSmithKline

Official(s) and/or principal investigator(s):
GSK Clinical Trials, Study Director, Affiliation: GlaxoSmithKline

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.

Clinical Details

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

Study design: Time Perspective: Prospective

Primary outcome: Occurrence of non-serious rash during 12 weeks of treatment with lamotrigine in patients with bipolar I in Korea

Secondary outcome: CGI-BP at Week 12 and occurrence of adverse events at Week 12

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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

Locations and Contacts

Additional Information

Related publications:

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.

Starting date: March 2007
Last updated: March 15, 2012

Page last updated: August 23, 2015

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