At a glance
ClinicalIndex Comparison Record- ✓Age 10–20 years
- ✓Able to swallow tablets
- ✓Diagnosed with bipolar disorder
- ✕General medical conditions such as head injury, epilepsy, endocrine disorders
- ✕Currently taking mood-altering medications such as steroids
- ✕Diagnosed with mental retardation
- ✕Pregnant girls or those planning to become pregnant during study
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Open Trial of Lamotrigine Monotherapy in Pediatric Bipolar Disorder
In Brief
A Phase 2 clinical trial evaluating Lamotrigine for Bipolar Disorder. Completed, enrolled 48 participants across 1 site.
Detailed 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.
Study Details
Timeline
Interventions
It is a mood stabilizer that is clinically the first choice if patients present with depression and is effective in adults for mania in maintenance phase. So it is administered to see how effective it is in children and adolescents. The dose of lamotrigine will be 12.5 mg per day beginning the first day. It is increased in 12.5 mg increments every week until it reaches 50 mg and 25 mg per week of increment thereafter until maximum dose of 150 mg in those below 50 kg and 200-400 mg depending on clinical response in those above 50 kg.