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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
370
Comprehensive Neuroscience of SCA
Cerritos, California, United States
AVI Clinical Research
Torrance, California, United States
Change from baseline to the final evaluation for the MRS from the SADS-C for the intent-to-treat dataset.
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.
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Washington Hospital Center
Washington D.C., 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
...and 8 more locations