Status:
COMPLETED
Lamotrigine Monotherapy in Pediatric Bipolar Disorder
Lead Sponsor:
University of Illinois at Chicago
Collaborating Sponsors:
GlaxoSmithKline
Conditions:
Bipolar Disorder
Eligibility:
All Genders
10-20 years
Phase:
PHASE2
Brief Summary
There are two purposes for this project. Study 1 is intended to study the safety and efficacy of Lamotrigine in stabilizing the mood in all phases of pediatric bipolar disorder (Phases: mixed, manic, ...
Detailed Description
Procedure Study 1 This study is planned to be conducted over 18 months, with an average recruitment of 2 subjects per month. Each subject is involved in the study for 18 to 26 weeks. While the study m...
Eligibility Criteria
Inclusion
- Ages 10-20
- Must be able to swallow tablets
- Must be diagnosed with bipolar disorder
Exclusion
- Children with general medical condition such as head injury, epilepsy, endocrine disorders
- Those who are on mood altering medications such as steroids, and those diagnosed with mental retardation are excluded to avoid confounding and contributing factors to mood swings.
- If we discover during the interview that the parent and/or child does not understand the consent/assent procedures, we will exclude them.
- Girls who are pregnant or plan to become pregnant during the study period will also be excluded from the research. There have been no concerns raised in the literature about the need for birth control practices in males treated with lamotrigine. As such, there are no provisions to exclude males from the research who do not practice birth control.
- We expect only a small number of children to be excluded from the study due to exclusionary criteria. Selection of the subjects is not based on sex, race, or ethnic group.
- For the fMRI study:
- Given the limited size of the magnet bore, individuals with a body weight over two-hundred and fifty pounds will be unable to be tested within the MRI scanner.
- Women in the latter stages of pregnancy may be excluded due to large body size and potential discomfort while in the MRI apparatus. Please note that girls who are taking part in the drug portion of the study (this includes all female subjects except the 5 healthy adult, control women) will be given 3 pregnancy during the drug study. This is to rule out pregnancy since pregnant girls should not be taking the study medications for safety reasons.
- Standard contraindications for fMRI studies include: cardiac pacemaker, aneurysm clip, cochlear implants, shrapnel, history of metal fragments in eyes, claustrophobia
- Participants with an IQ of less than 70 (assessed by WRAT) are likely to be excluded due to difficulties comprehending tasks and procedures
Key Trial Info
Start Date :
February 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2008
Estimated Enrollment :
48 Patients enrolled
Trial Details
Trial ID
NCT00176228
Start Date
February 1 2004
End Date
January 1 2008
Last Update
July 30 2015
Active Locations (1)
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1
NPI, University of Illinois at Chicago
Chicago, Illinois, United States, 60612