Phase 2
N=48
Lamotrigine Monotherapy in Pediatric Bipolar Disorder
Bipolar Disorder
Bottom Line
View on ClinicalTrials.gov: NCT00176228 ↗Enrolled (actual)
48
Serious AEs
0.0%
Results posted
Jul 2015
Primary outcome: Primary: Young Mania Rating Scale (YMRS), — 19.61; 7.06; 5.68 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Lamotrigine (Drug)
- Age
- Pediatric, Adult · 10+ yrs
- Sex
- All
- Sponsor
- University of Illinois at Chicago
- Primary completion
- Jan 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Young Mania Rating Scale (YMRS), |
19.61; 7.06; 5.68 | — |
| SECONDARY Child Depression Rating Scale (CDRS-R) |
52; 31.39; 26.10 | — |
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, hypomanic, or depressed episodes) in 8-17 year old children. These children and adolescents must be treatment resistant (who failed on two adequate trials of mood stabilizing medications) to qualify for this study. Study 2 is aimed at examining brain activity and/or dysfunction before lamotrigine treatment, and to look for any alteration after lamotrigine treatment. Brain systems associated with attention and emotional processing will targeted.
Eligibility Criteria
Inclusion Criteria
- Ages 10-20
- Must be able to swallow tablets
- Must be diagnosed with bipolar disorder
Exclusion Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT00176228). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.