Lamictal Bipolar Observational Study

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00460226

Enrollment

238

Registered

2007-04-13

Start date

2007-03-31

Completion date

2007-12-31

Last updated

2012-03-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bipolar Disorder

Keywords

Korean, Bipolar I disorder, Non-serious rash, Lamotrigine

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.

Interventions

DRUGlamotrigine

lamotrigine treatment for 12weeks

Study design

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Occurrence of non-serious rash during 12 weeks of treatment with lamotrigine in patients with bipolar I in Korea	12 weeks

Secondary

Measure	Time frame
CGI-BP at Week 12 and occurrence of adverse events at Week 12	12 weeks

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026