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Sponsors and Collaborators: |
Creighton University Abbott |
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Information provided by: | Creighton University |
ClinicalTrials.gov Identifier: | NCT00208195 |
The purpose of this study is to ascertain whether Depakote ER (Divalproex ER) has efficacy in the treatment of patients with bipolar disorder in the manic phase, who also have comorbid substance abuse diagnoses. It is proposed that Depakote ER will decrease scores on the Young Mania Rating Scale and the Substance Abuse Time Line Follow Back.
Condition | Intervention | Phase |
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Bipolar Disorder Mania Substance Abuse Substance Dependence |
Drug: Divalproex ER |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Active Control, Single Group Assignment, Efficacy Study |
Official Title: | Depakote ER Therapy for Mania Comorbid With Substance Abuse |
Enrollment: | 20 |
Study Start Date: | March 2004 |
Study Completion Date: | November 2007 |
This study will be performed in male and female subjects with a diagnosis of bipolar disorder in the manic phase of the illness who also have a comorbid diagnosis of substance abuse. This population is selected so the efficacy of Depakote ER in this population can be tested.
Ages Eligible for Study: | 19 Years to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
United States, Nebraska | |
Creighton University Psychiatry Research Center | |
Omaha, Nebraska, United States, 68131 |
Principal Investigator: | Pirzada Sattar, MD | Creighton University |
Responsible Party: | Creighton University ( Syed Pirzada Sattar, M.D. ) |
Study ID Numbers: | 03-13258 |
Study First Received: | September 14, 2005 |
Last Updated: | December 12, 2007 |
ClinicalTrials.gov Identifier: | NCT00208195 |
Health Authority: | United States: Institutional Review Board |
Bipolar Disorder Mania Substance Abuse Substance Dependence Comorbid |
Affective Disorders, Psychotic Mental Disorders Bipolar Disorder Mood Disorders |
Substance-Related Disorders Disorders of Environmental Origin Psychotic Disorders Valproic Acid |