Bipolar Disorder Clinical Trial
Official title:
A Pilot Open Study of the Safety and Effectiveness of Lamotrigine for the Treatment of Mania in Youth Ages 6-17 With Bipolar I, Bipolar II, and Bipolar Spectrum Disorders
The main objective of this study is to assess the effectiveness and safety of lamotrigine in the treatment of youth with bipolar and bipolar spectrum disorder. This is an exploratory, 12-week, open-label treatment period, pilot study, of youth ages 6-17, who meet the DSM-IV diagnostic criteria for bipolar I, bipolar II, or bipolar spectrum disorder. The study results will be used to generate hypotheses for a larger randomized controlled clinical trial. Based on the available literature in adults with bipolar disorder, we hypothesized that lamotrigine will be efficacious and well tolerated in youth with pediatric bipolar and bipolar spectrum disorders.
Lamotrigine is a new generation antiepileptic drug, approved by the FDA in 2003 for the
maintenance treatment of adults with Bipolar I disorder to delay the time to occurrence of
mood episodes (depression, mania, hypomania,& mixed episodes) in patients treated for acute
mood episodes with standard therapy. Recent studies have shown that Lamotrigine maintenance
treatment was more robust in bipolar depression.
The study includes 1) use of a 12-week design to document the response rate 2) assessment of
the impact of Lamotrigine on functional capacities and cognition, 3) careful assessment of
safety and tolerability.
;
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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