Study of Depakote ER for the Treatment of Mania in Children Ages 6-12 With Bipolar Disorder
Status:
Completed
Trial end date:
2006-11-01
Target enrollment:
Participant gender:
Summary
This is an open-labeled study of Divalproex Sodium Extended Release (Depakote ER), testing
its efficacy for the treatment of mania in children between the ages of 6-12 who have been
diagnosed with Bipolar I, Bipolar II, and Bipolar Spectrum Disorders. This is an exploratory,
pilot study, seeking to determine whether Divalproex Sodium Extended Release is efficacious
and well tolerated in the treatment of youth with pediatric bipolar and bipolar spectrum
disorder, and the study results will be used to generate hypotheses for a larger randomized
controlled clinical trial with explicit hypotheses and sufficient statistical power.