Status:
COMPLETED
Depakote ER Therapy for Mania Comorbid With Substance Abuse
Lead Sponsor:
Creighton University
Collaborating Sponsors:
Abbott
Conditions:
Bipolar Disorder
Mania
Eligibility:
All Genders
19-65 years
Phase:
PHASE4
Brief Summary
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...
Detailed Description
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 i...
Eligibility Criteria
Inclusion
- Ages 19 - 65.
- Diagnosis of mania with comorbid substance confirmed by Structured Clinical Interview for DSM-IV.
- Comorbid diagnoses of anxiety and/or personality disorders are permitted.
- Ability to provide signed informed consent.
- Stable general medical health.
- Ability to attend outpatient research clinic.
Exclusion
- Dangerous to self or others.
- Pregnancy, inability or unwillingness to use approved methods of birth control.
- Inability or unwillingness to provide signed informed consent.
- Diagnosis of schizophrenia, major depressive disorder.
- Inability to attend outpatient research clinic.
- Medical conditions, which would preclude use of Depakote.
- Need for ongoing treatment with medication other than Depakote ER, such as antipsychotic medication.
- Medical instability defined as likelihood of needing to change prescription medication during the course of the study.
Key Trial Info
Start Date :
March 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2007
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT00208195
Start Date
March 1 2004
End Date
November 1 2007
Last Update
December 14 2007
Active Locations (1)
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1
Creighton University Psychiatry Research Center
Omaha, Nebraska, United States, 68131