An Inpatient Study of the Effectiveness and Safety of Depakote ER in the Treatment of Mania/Bipolar Disorder
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|ClinicalTrials.gov Identifier: NCT00060905|
Recruitment Status : Completed
First Posted : May 16, 2003
Last Update Posted : August 4, 2006
|Condition or disease||Intervention/treatment||Phase|
|Bipolar Disorder||Drug: Divalproex Sodium (Depakote ER)||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Enrollment :||370 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||An Inpatient Study of the Effectiveness and Safety of Depakote ER in the Treatment of Mania/Bipolar Disorder|
|Study Start Date :||January 2003|
- 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.
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): NCT00060905
|Study Director:||Global Medical Information - Abbott||Abbott|