A Randomized Control Trial Comparing Quetiapine to Risperidone in Bipolar Disorder With Stimulant Dependence

• Status: Completed
• Trial end date: 2006-11-01
• Target enrollment: 0
• Participant gender: All

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 methamphetamine dependence.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Texas Southwestern Medical Center
• Collaborators: Stanley Medical Research Institute; University of North Texas Health Science Center
• Treatments: Central Nervous System Stimulants; Quetiapine Fumarate; Risperidone

Criteria

Inclusion criteria:

1. English-speaking men and women (20-50 years old) of all ethnic origins

2. Outpatients with a current DSM-IV diagnosis of bipolar I with or without psychotic features or bipolar II disorder

3. Current cocaine or methamphetamine dependence

4. Currently experiencing hypomanic, manic, or mixed state episodes with a Young Mania Rating Scale23 (YMRS11) score of > 9

5. Currently craving stimulants with a craving score of > 20 on the 10-item, self-reported Stimulant Craving Questionnaire24 (SCQ10)

6. A high school diploma, GED, or Shipley IQ test score of >85.

Exclusion criteria:

1. 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)

2. DSM-IV diagnosis of substance-induced mood disorder

3. Pregnant or breast-feeding

4. History of special education, mental retardation, dementia

5. 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)

6. Central nervous system diseases (e.g., multiple sclerosis, severe head trauma, or seizures)

7. Contraindications or allergic reactions to study medications

8. Currently participating in any other research program

9. Urine positive for glucose or ketones

10. Currently receiving any antipsychotic medications or more than two psychotropic medications

11. Currently receiving benzodiazepines, sedatives or stimulants

12. Any other current substance dependence

13. Cataracts or glaucoma

14. EKG evidence of QT prolongation.