Last updated: 11/04/2018 08:46:56

Lamictal Bipolar Observational Study

GSK study ID
LBI108245
See study documents
Clinicaltrials.gov ID
NCT00460226
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

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
Trial description: This is multi-center, prospective, observational stud. This study is designed to evaluate the rate of non-serious rash in Korean bipolar I patients.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:

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

Timeframe: 12 weeks

Secondary outcomes:

CGI-BP at Week 12 and occurrence of adverse events at Week 12

Timeframe: 12 weeks

Interventions:
  • Drug: lamotrigine
    • Enrollment:
    238
    Primary completion date:
    Not applicable
    Observational study model:
    Other
    Time perspective:
    Prospective
    Clinical 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.Progress in Neuro-Psychopharmacology & Biological Psychiatry 2009; 33: 1147-1152
    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.Progress in Neuro-Psychopharmacology & Biological Psychiatry 2009; 33: 1147-1152
    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].
    Medical condition
    Bipolar Disorder
    Product
    lamotrigine
    Collaborators
    Not applicable
    Study date(s)
    March 2007 to December 2007
    Type
    Observational
    Phase
    Not applicable

    Participation criteria

    Sex
    Female & Male
    Age
    18+ years
    Accepts healthy volunteers
    No
    • A subject will be eligible for inclusion in this study only if all of the following criteria apply:
    • Provides written informed consent
    • A subject will not be eligible for inclusion in this study if any of the following criteria apply:
    • Previous or current treatment with lamotrigine
    Inclusion and exclusion 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

    Trial location(s)

    This study does not involve prospective enrollment of participants.

    Study documents

    Scientific result summary
    Available language(s): English
    Download document(s)

    If you wish to request for full study report, please contact - [email protected]

    Results overview

    Refer to study documents

    Recruitment status
    Study complete
    Actual primary completion date
    Not applicable
    Actual study completion date
    2007-13-12

    Plain language summaries

    Not applicable. GSK’s transparency policy provides for Plain Language Summaries for Interventional studies.

    Additional information about the trial

    Not applicable
    Participate in clinical trial
    Access to clinical trial data by researchers
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