Lithium Versus Divalproex for Treating Pediatric Bipolar Disorder
Recruitment status was Active, not recruiting
|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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00221429
|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|