Lamictal Bipolar Observational Study
Information source: GlaxoSmithKline
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Bipolar I Disorder
Intervention: Lamotrigine (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: GlaxoSmithKline Official(s) and/or principal investigator(s):
GSK Clinical Trials, MD, Study Director, Affiliation: GlaxoSmithKline
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.
Clinical Details
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 design: Prospective
Primary outcome: Occurrence of adverse events after ropinirole administration
Secondary outcome: Occurrence of unexpected adverse events after ropinirole administration
Occurrence of serious adverse events after ropinirole administration
Improvement assessment according to the investigator's medical judgement
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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
Locations and Contacts
GSK Clinical Trials Call Center, Seoul 150-713, Korea, Republic of
Additional Information
Starting date: March 2007
Ending date: December 2007
Last updated: March 27, 2008
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