The purpose of this study is to determine the safety and effectiveness of Depakote ER (Divalproex Sodium Extended-Release Tablets) compared to placebo in the treatment of bipolar disorder, manic or mixed type in children and adolescents ages 10-17 years.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
150
Stanford University
Stanford, California, United States
Childrens National Medical Center
Washington D.C., District of Columbia, United States
Change from baseline to the final evaluation in Y-MRS score.
Vital signs
Adverse events
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Unnamed facility
Altamonte Springs, Florida, United States
Professional Clinical Research, Inc.
Miami, Florida, United States
Segal Institute for Clinical Research
North Miami, Florida, United States
Mountain West Clinical Trials
Boise, Idaho, United States
Capstone Clinical Research
Libertyville, Illinois, United States
Cientifica Inc at Praire View, Inc.
Newton, Kansas, United States
Unnamed facility
Lexington, Kentucky, United States
LSU - Health Science Center
New Orleans, Louisiana, United States
...and 6 more locations