Last updated: 11/04/2018 08:46:56
Lamictal Bipolar Observational Study
Clinicaltrials.gov ID
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Finalized
Finalized
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
Observational study model:
Other
Primary completion date:
Not applicable
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)
No location data available.
Study documents
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Refer to study documents
Recruitment status
Finalized
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
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