Lithium Versus Divalproex for Treating Pediatric Bipolar Disorder
|ClinicalTrials.gov Identifier: NCT00221429|
Recruitment Status : Unknown
Verified November 2002 by National Institute of Mental Health (NIMH).
Recruitment status was: Active, not recruiting
First Posted : September 22, 2005
Last Update Posted : February 23, 2006
|Condition or disease||Intervention/treatment||Phase|
|Bipolar Disorder||Drug: lithium sodium divalproex||Phase 3|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||154 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Pediatric Bipolar Collaborative Mood Stabilizer Trial|
|Study Start Date :||March 2001|
- YMRS & CGI-I
- CDRS & MRS
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|