Status:
COMPLETED
A Randomized Control Trial Comparing Quetiapine to Risperidone in Bipolar Disorder With Stimulant Dependence
Lead Sponsor:
University of Texas Southwestern Medical Center
Collaborating Sponsors:
Stanley Medical Research Institute
University of North Texas Health Science Center
Conditions:
Bipolar Disorder
Cocaine Dependence
Eligibility:
All Genders
20-50 years
Phase:
NA
Brief Summary
The purpose of this study is to determine whether quetiapine or risperidone are effective in treating mood symptoms, drug cravings and use in bipolar disorder with concurrent cocaine or methamphetamin...
Detailed Description
Bipolar disorder may be associated with the highest rates of substance abuse of any psychiatric illness. Studies suggest that substance abuse in persons with bipolar disorder have lifetime prevalence ...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- English-speaking men and women (20-50 years old) of all ethnic origins
- Outpatients with a current DSM-IV diagnosis of bipolar I with or without psychotic features or bipolar II disorder
- Current cocaine or methamphetamine dependence
- Currently experiencing hypomanic, manic, or mixed state episodes with a Young Mania Rating Scale23 (YMRS11) score of \> 9
- Currently craving stimulants with a craving score of \> 20 on the 10-item, self-reported Stimulant Craving Questionnaire24 (SCQ10)
- A high school diploma, GED, or Shipley IQ test score of \>85.
- Exclusion criteria:
- Inpatients or anyone with a high risk for suicide (i.e., active suicidal ideation with a proposed plan, history of any suicide attempt within the last 6 months)
- DSM-IV diagnosis of substance-induced mood disorder
- Pregnant or breast-feeding
- History of special education, mental retardation, dementia
- HIV/AIDS, reactive hepatitis, hepatic cirrhosis or any active liver disease, personal or familial history of diabetes, personal history of heart disease (i.e., congenital heart abnormalities, congestive heart failure, chronic atrial fibrillation, rheumatic heart disease, heart attack)
- Central nervous system diseases (e.g., multiple sclerosis, severe head trauma, or seizures)
- Contraindications or allergic reactions to study medications
- Currently participating in any other research program
- Urine positive for glucose or ketones
- Currently receiving any antipsychotic medications or more than two psychotropic medications
- Currently receiving benzodiazepines, sedatives or stimulants
- Any other current substance dependence
- Cataracts or glaucoma
- EKG evidence of QT prolongation.
Exclusion
Key Trial Info
Start Date :
October 1 2002
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2006
Estimated Enrollment :
96 Patients enrolled
Trial Details
Trial ID
NCT00227123
Start Date
October 1 2002
End Date
November 1 2006
Last Update
January 4 2008
Active Locations (2)
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1
University of Texas Southwestern Medical Center at Dallas
Dallas, Texas, United States, 75390
2
Universty of North Texas Health Science Center
Fort Worth, Texas, United States, 76107