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

This study has been completed.
Sponsor:
Collaborators:
Stanley Medical Research Institute
University of North Texas Health Science Center
Information provided by:
University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier:
NCT00227123
First received: September 23, 2005
Last updated: January 3, 2008
Last verified: October 2007
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Ages Eligible for Study:   20 Years to 50 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided by University of Texas Southwestern Medical Center

Additional 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
Study First Received: September 23, 2005
Last Updated: January 3, 2008
Health Authority: United States: Institutional Review Board

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

Additional relevant MeSH terms:
Bipolar Disorder
Disease
Affective Disorders, Psychotic
Mood Disorders
Mental Disorders
Pathologic Processes
Quetiapine
Risperidone
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Psychotropic Drugs
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Dopamine Antagonists
Dopamine Agents

ClinicalTrials.gov processed this record on September 22, 2014