This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. We are conducting a four-year, three-site (CHW, Case Western, and University of Cincinnati) study of acute phase treatment of child and adolescent Bipolar I Disorder. The primary aim of this project is to compare the efficacy of Lithium (Li), Divalproex Sodium (DVP), and placebo (PBO) in 8 weeks of acute phase treatment of symptomatic Bipolar I Disorder in children and adolescents ages 7-17 years old. Our hypothesis is that differential efficacy will be observed with the following predicted order of response: DVP=Li>PBO. The secondary aims are: 1) To provide descriptive data and effect size estimates of treatment with Li or DVP. 2) To collect systematic safety data on the incidence of weight gain, polycystic ovaries, and hyperandrogenism in bipolar adolescent females treated with Li or DVP. 3) To collect data on possible predictors of acute treatment response to the two active treatments. 4) To provide descriptive information on the stability of acute phase response to monotherapy with either Li or DVP over 16 weeks of continuation phase treatment. No previous studies have compared Li, DVP, and PBO. This multi-site study will allow for a comparison of whether or not the two active treatments are more efficacious than PBO. Due to the presumed closeness in efficacy between the two active treatments, Li amp; DVP, we do not expect to detect a significant difference between these two groups, but we may find that patients tolerate one of the treatments over another and our pilot data found a 10% difference in response rates between Li and DVP, which is clinically significant. These results will have significant impact on not only clinical treatment of Bipolar Disorder, but also on future research questions on safety and efficacy of such treatments. No studies have looked at the question of weight gain, polycystic ovaries, and endocrine abnormalities in female bipolar adolescents treated with mood stabilizers. Because of the frequent use of mood stabilizers in bipolar adolescents, this is an important area in which to systematically collect prospective data. Results will indicate whether further study in this area is warranted. We will also be able to provide descriptive data and effect size estimates of patients treated with Li or DVP and collect data on possible predictors of acute treatment response to the two active treatments. Lastly, this trail will provide descriptive information on the stability of acute phase response to monotherapy over a 16 week continuation phase. Stability of treatment responses and possible variations on monotherapy treatments would be important future directions for research.
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