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
1 other identifier
observational
238
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Mar 2007
Shorter than P25 for all trials
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2007
CompletedFirst Submitted
Initial submission to the registry
April 12, 2007
CompletedFirst Posted
Study publicly available on registry
April 13, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2007
CompletedMarch 19, 2012
January 1, 2011
9 months
April 12, 2007
March 15, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Occurrence of non-serious rash during 12 weeks of treatment with lamotrigine in patients with bipolar I in Korea
12 weeks
Secondary Outcomes (1)
CGI-BP at Week 12 and occurrence of adverse events at Week 12
12 weeks
Study Arms (1)
lamotrigine
there is only one group.
Interventions
Eligibility Criteria
Patient setting and reflecting usual clinical practice in general hospital
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- GlaxoSmithKlinelead
Related 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.
PMID: 19540298BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
GSK Clinical Trials
GlaxoSmithKline
Study Design
- Study Type
- observational
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 12, 2007
First Posted
April 13, 2007
Study Start
March 1, 2007
Primary Completion
December 1, 2007
Study Completion
December 1, 2007
Last Updated
March 19, 2012
Record last verified: 2011-01