Lamictal Bipolar Observational Study

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ClinicalTrials.gov Identifier: NCT00460226

Recruitment Status : Completed

First Posted : April 13, 2007

Last Update Posted : March 19, 2012

Sponsor:

Information provided by (Responsible Party):

GlaxoSmithKline

Study Description

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.

Condition or disease	Intervention/treatment
Bipolar Disorder	Drug: lamotrigine

Study Design

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Study Type :	Observational
Actual Enrollment :	238 participants
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
Study Start Date :	March 2007
Actual Primary Completion Date :	December 2007
Actual Study Completion Date :	December 2007

Resource links provided by the National Library of Medicine

Genetics Home Reference related topics: Bipolar disorder

MedlinePlus related topics: Rashes

Drug Information available for: Lamotrigine

U.S. FDA Resources

Groups and Cohorts

Group/Cohort	Intervention/treatment
lamotrigine there is only one group.	Drug: lamotrigine lamotrigine treatment for 12weeks

Outcome Measures

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 ]

Secondary Outcome Measures :

CGI-BP at Week 12 and occurrence of adverse events at Week 12 [ Time Frame: 12 weeks ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:	18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No
Sampling Method:	Probability Sample

Study Population

Patient setting and reflecting usual clinical practice in general hospital

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

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00460226

Sponsors and Collaborators

GlaxoSmithKline

Investigators

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Study Director:	GSK Clinical Trials	GlaxoSmithKline

More Information

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.

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Responsible Party:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT00460226 History of Changes
Other Study ID Numbers:	LBI108245
First Posted:	April 13, 2007 Key Record Dates
Last Update Posted:	March 19, 2012
Last Verified:	January 2011

Keywords provided by GlaxoSmithKline:


Korean Bipolar I disorder Non-serious rash Lamotrigine

Additional relevant MeSH terms:

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Bipolar Disorder Bipolar and Related Disorders Mental Disorders Lamotrigine Anticonvulsants Calcium Channel Blockers Membrane Transport Modulators Molecular Mechanisms of Pharmacological Action	Calcium-Regulating Hormones and Agents Physiological Effects of Drugs Antipsychotic Agents Tranquilizing Agents Central Nervous System Depressants Psychotropic Drugs Sodium Channel Blockers

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