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

Completed · Not applicable

Conditions studied: Bipolar Disorder, Cocaine Dependence, Methamphetamine Dependence

In brief

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.

Key facts

Study ID

NCT00227123

Run by

University of Texas Southwestern Medical Center

People needed

96

Starts

2002-10-01

Expected to finish

2006-11-01

Last updated by the study team

2008-01-04

Who can join

Age: 20 and older, up to 50. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• University of Texas Southwestern Medical Center at Dallas — Dallas, Texas, United States
• Universty of North Texas Health Science Center — Fort Worth, Texas, United States

Full record on ClinicalTrials.gov

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