Lamotrigine for the Treatment of Mania in Youth Ages 6-17 With Bipolar Disorder
Status:
Completed
Trial end date:
2008-04-01
Target enrollment:
Participant gender:
Summary
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.