An Outpatient Study of the Effectiveness and Safety of Depakote ER in the Treatment of Mania/Bipolar Disorder in Children and Adolescents
- Conditions
- Bipolar Disorder
- Registration Number
- NCT00067262
- Lead Sponsor
- Abbott
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 150
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Change from baseline to the final evaluation in Y-MRS score.
- Secondary Outcome Measures
Name Time Method Vital signs Adverse events
Related Research Topics
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Trial Locations
- Locations (13)
Stanford University
🇺🇸Stanford, California, United States
Childrens National Medical Center
🇺🇸Washington, District of Columbia, 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
LSU - Health Science Center
🇺🇸New Orleans, Louisiana, United States
Brentwood Research Institute
🇺🇸Shreveport, Louisiana, United States
New Oakland Child/Adoles and Family Center
🇺🇸Clinton Township, Michigan, United States
Scroll for more (3 remaining)Stanford University🇺🇸Stanford, California, United States