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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
Information provided by (Responsible Party):

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 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
Primary Completion Date : December 2007
Study Completion Date : December 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Rashes
Drug Information available for: Lamotrigine
U.S. FDA Resources

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

Primary Outcome Measures :
  1. 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 :
  1. CGI-BP at Week 12 and occurrence of adverse events at Week 12 [ Time Frame: 12 weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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

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

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
Study Director: GSK Clinical Trials GlaxoSmithKline

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:
Bipolar I disorder
Non-serious rash

Additional relevant MeSH terms:
Bipolar Disorder
Bipolar and Related Disorders
Mental Disorders
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers