An Inpatient Study of the Effectiveness and Safety of Depakote ER in the Treatment of Mania/Bipolar Disorder
- Conditions
- Bipolar Disorder
- Registration Number
- NCT00060905
- Lead Sponsor
- Abbott
- Brief Summary
The purpose of this study is to determine the safety and effectiveness of Depakote ER compared to placebo in the treatment of bipolar disorder, manic or mixed type in adults.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 370
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 for the MRS from the SADS-C for the intent-to-treat dataset.
- Secondary Outcome Measures
Name Time Method Change from baseline to the final evaluation for the Manic Syndrome Scale (MSS), Behavior and Ideation Scale (BIS), BPRS (and published subscales), Global Assessment Scale (GAS), the Nursing Observation Scale for Inpatient Evaluation (NOSIE), and Burden Questionnaire, as well as the percentage of subjects with at least 50% improvement on the MRS.
Trial Locations
- Locations (18)
Comprehensive Neuroscience of SCA
🇺🇸Cerritos, California, United States
AVI Clinical Research
🇺🇸Torrance, California, United States
Washington Hospital Center
🇺🇸Washington, District of Columbia, United States
Mark Lerman, MD
🇺🇸Hoffman Estates, Illinois, United States
University of Louisville Bipolar Research Program
🇺🇸Louisville, Kentucky, United States
Brentwood Research Inst.
🇺🇸Shreveport, Louisiana, United States
Centers for Behavioral Health, LLC
🇺🇸Rockville, Maryland, United States
McLean Hospital
🇺🇸Belmont, Massachusetts, United States
Pioneer Research
🇺🇸Baltimore, Michigan, United States
University of Mississippi Medical Center
🇺🇸Jackson, Mississippi, United States
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