Back to resultsDepakote ER Therapy for Mania Comorbid With Substance Abuse
Primary Purpose
Bipolar Disorder, Mania, Substance Abuse
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Divalproex ER
Sponsored by
About this trial
This is an interventional treatment trial for Bipolar Disorder focused on measuring Bipolar Disorder, Mania, Substance Abuse, Substance Dependence, Comorbid
Eligibility Criteria
Inclusion Criteria: 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 Criteria: 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.
Sites / Locations
- Creighton University Psychiatry Research Center
Outcomes
Primary Outcome Measures
The primary outcome measures will consist of the total score on the YMRS, and the number of days abstinent from substances of abuse with the TLFB.
Secondary Outcome Measures
The Addiction Severity Index (ASI), Penn Alcohol Craving Scale, and Clinical Global Impression (CGI).
Full Information
NCT ID
NCT00208195
First Posted
September 14, 2005
Last Updated
December 12, 2007
Sponsor
Creighton University
Collaborators
Abbott
1. Study Identification
Unique Protocol Identification Number
NCT00208195
Brief Title
Depakote ER Therapy for Mania Comorbid With Substance Abuse
Official Title
Depakote ER Therapy for Mania Comorbid With Substance Abuse
Study Type
Interventional
2. Study Status
Record Verification Date
December 2007
Overall Recruitment Status
Completed
Study Start Date
March 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
November 2007 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Creighton University
Collaborators
Abbott
4. Oversight
Data Monitoring Committee
No
5. Study Description
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 diagnoses. It is proposed that Depakote ER will decrease scores on the Young Mania Rating Scale and the Substance Abuse Time Line Follow Back.
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 is selected so the efficacy of Depakote ER in this population can be tested.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bipolar Disorder, Mania, Substance Abuse, Substance Dependence
Keywords
Bipolar Disorder, Mania, Substance Abuse, Substance Dependence, Comorbid
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Divalproex ER
Primary Outcome Measure Information:
Title
The primary outcome measures will consist of the total score on the YMRS, and the number of days abstinent from substances of abuse with the TLFB.
Time Frame
Patients will be evaluated on a weekly basis for the first month, then every 2 weeks for the next 2 months, then monthly for the next 3 months for a total study duration of 6 months
Secondary Outcome Measure Information:
Title
The Addiction Severity Index (ASI), Penn Alcohol Craving Scale, and Clinical Global Impression (CGI).
Time Frame
Patients will be evaluated on a weekly basis for the first month, then every 2 weeks for the next 2 months, then monthly for the next 3 months, for a total study duration of 6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
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 Criteria:
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pirzada Sattar, MD
Organizational Affiliation
Creighton University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Creighton University Psychiatry Research Center
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68131
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Depakote ER Therapy for Mania Comorbid With Substance Abuse
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