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Lamictal Bipolar Observational Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date April 12, 2007
First Posted Date April 13, 2007
Last Update Posted Date March 19, 2012
Study Start Date March 2007
Actual Primary Completion Date December 2007   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: August 13, 2009)
Occurrence of non-serious rash during 12 weeks of treatment with lamotrigine in patients with bipolar I in Korea [ Time Frame: 12 weeks ]
Original Primary Outcome Measures Not Provided
Change History Complete list of historical versions of study NCT00460226 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: August 13, 2009)
CGI-BP at Week 12 and occurrence of adverse events at Week 12 [ Time Frame: 12 weeks ]
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Lamictal Bipolar Observational Study
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
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.
Detailed Description Not Provided
Study Type Observational
Study Design Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population Patient setting and reflecting usual clinical practice in general hospital
Condition Bipolar Disorder
Intervention Drug: lamotrigine
lamotrigine treatment for 12weeks
Study Groups/Cohorts lamotrigine
there is only one group.
Intervention: Drug: lamotrigine
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: August 13, 2009)
238
Original Enrollment
 (submitted: April 12, 2007)
408
Actual Study Completion Date December 2007
Actual Primary Completion Date December 2007   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Not Provided
Removed Location Countries Korea, Republic of
 
Administrative Information
NCT Number NCT00460226
Other Study ID Numbers LBI108245
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party GlaxoSmithKline
Study Sponsor GlaxoSmithKline
Collaborators Not Provided
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
PRS Account GlaxoSmithKline
Verification Date January 2011