Lithium Versus Divalproex for Treating Pediatric Bipolar Disorder
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|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)|
|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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|