Lithium Versus Divalproex for Treating Pediatric Bipolar Disorder
Recruitment status was Active, not recruiting
This study will compare the efficacy of lithium, divalproex, and placebo in treating the acute phase of symptomatic bipolar I disorder, mixed or manic episode, in children and adolescents.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
|Official Title:||Pediatric Bipolar Collaborative Mood Stabilizer Trial|
- YMRS & CGI-I
- CDRS & MRS
|Study Start Date:||March 2001|
To compare the efficacy of LI, DVP, and PBO in the acute phase treatment of symptomatic bipolar I disorder, mixed or manic episode, in children and adolescents. Our hypothesis is that differential efficacy will be observed with the following predicted order of response: DVP = LI > PBO.
- To collect systematic safety data on the incidence of weight gain and the development of insulin resistance and hyperandrogenism in bipolar adolescent females treated with LI, DVP, or LI + DVP.
- To collect data on possible predictors of acute treatment response to the two active treatments.
- To provide descriptive information on the stability of acute phase response to monotherapy with either LI or DVP over 6 months of continuation phase treatment.
- To develop safety and efficacy data about the use of stimulant medications in these subject while treated with a mood stabilizer.
|United States, Ohio|
|University of Cincinnati Medical Center/Medical Sciences Building|
|Cincinnati, Ohio, United States, 45267|
|Principal Investigator:||Robert A Kowatch, MD||University of Cincinnati|