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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00227123
First Posted: September 27, 2005
Last Update Posted: January 4, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Stanley Medical Research Institute
University of North Texas Health Science Center
Information provided by:
University of Texas Southwestern Medical Center
  Purpose
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.

Condition Intervention
Bipolar Disorder Cocaine Dependence Methamphetamine Dependence Drug: quetiapine, risperidone

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized Control Trial Comparing Quetiapine to Risperidone in Bipolar Disorder Outpatients With Current Stimulant Dependence

Resource links provided by NLM:


Further study details as provided by University of Texas Southwestern Medical Center:

Primary Outcome Measures:
  • Mood symptom improvement. [ Time Frame: Baseline to exit ]
  • Cocaine or methamphetamine cravings and use. [ Time Frame: Baseline to exit ]

Secondary Outcome Measures:
  • Body Mass Index [ Time Frame: Baseline to Exit ]

Enrollment: 96
Study Start Date: October 2002
Study Completion Date: November 2006
Arms Assigned Interventions
Active Comparator: 1
Quetiapine versus Risperidone
Drug: quetiapine, risperidone
Flexible dose titrations to 'treat-to-symptoms'
Other Names:
  • Seroquel
  • Risperdal

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 rates as high as 60% with reports of cocaine abuse as high as 30%. Comorbid substance abuse in persons with bipolar disorder is associated with increased hospitalization, poorer psychiatric recovery and treatment response than in patients with bipolar disorder alone. Thus, therapeutic agents that may enhance prognosis by improving psychiatric outcomes, reducing stimulant cravings, and increasing treatment retention are of considerable interest. In a previous study conducted in this lab, we found that conventional neuroleptic agents were associated with an increase in depressive symptoms and a significant increase in stimulant cravings. These results mirror preclinical animal data that show conventional neuroleptics (i.e.haloperidol) with high dopamine receptor binding affinities actually increase cocaine self-administration in rats and monkeys. These results are clinically relevant as persons with bipolar disorder who abuse cocaine and other drugs often receive higher doses of conventional neuroleptics than those without cocaine or other drug abuse. In contrast to conventional neuroleptic therapy, atypical antipsychotics (i.e. quetiapine, risperidone), decrease self-administration of cocaine. The receptor binding profile of the atypical antipsychotics broadly vary although all agents in this drug class are known as serotonin-dopamine antagonists. Quetiapine has 'moderate' dopamine binding, while risperidone has 'high' dopamine receptor binding properties similar to conventional neuroleptic agents. Thus, our hypothesis is that quetiapine may be a more efficacious agent than risperidone in treating bipolar mood symptoms while attenuating drug cravings and use.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00227123


Locations
United States, Texas
University of Texas Southwestern Medical Center at Dallas
Dallas, Texas, United States, 75390
Universty of North Texas Health Science Center
Fort Worth, Texas, United States, 76107
Sponsors and Collaborators
University of Texas Southwestern Medical Center
Stanley Medical Research Institute
University of North Texas Health Science Center
Investigators
Principal Investigator: Vicki A. Nejtek, Ph.D. University of North Texas Health Science Center
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00227123     History of Changes
Other Study ID Numbers: 0602342
02T147
First Submitted: September 23, 2005
First Posted: September 27, 2005
Last Update Posted: January 4, 2008
Last Verified: October 2007

Keywords provided by University of Texas Southwestern Medical Center:
Bipolar, cocaine, methamphetamine,quetiapine,risperidone

Additional relevant MeSH terms:
Disease
Bipolar Disorder
Cocaine-Related Disorders
Pathologic Processes
Bipolar and Related Disorders
Mental Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Risperidone
Quetiapine Fumarate
Central Nervous System Stimulants
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Dopamine Antagonists
Dopamine Agents