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

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.
 
ClinicalTrials.gov Identifier: NCT00227123
Recruitment Status : Completed
First Posted : September 27, 2005
Last Update Posted : January 4, 2008
Sponsor:
Collaborators:
Stanley Medical Research Institute
University of North Texas Health Science Center
Information provided by:
University of Texas Southwestern Medical Center

Tracking Information
First Submitted Date  ICMJE September 23, 2005
First Posted Date  ICMJE September 27, 2005
Last Update Posted Date January 4, 2008
Study Start Date  ICMJE October 2002
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: January 3, 2008)
  • Mood symptom improvement. [ Time Frame: Baseline to exit ]
  • Cocaine or methamphetamine cravings and use. [ Time Frame: Baseline to exit ]
Original Primary Outcome Measures  ICMJE
 (submitted: September 23, 2005)
  • Manic and depressive symptom improvement.
  • Reduced drug craving and use.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 3, 2008)
Body Mass Index [ Time Frame: Baseline to Exit ]
Original Secondary Outcome Measures  ICMJE
 (submitted: September 23, 2005)
  • Treatment retention.
  • Neurocognitive improvement.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Randomized Control Trial Comparing Quetiapine to Risperidone in Bipolar Disorder With Stimulant Dependence
Official Title  ICMJE A Randomized Control Trial Comparing Quetiapine to Risperidone in Bipolar Disorder Outpatients With Current Stimulant Dependence
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 methamphetamine dependence.
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Bipolar Disorder
  • Cocaine Dependence
  • Methamphetamine Dependence
Intervention  ICMJE Drug: quetiapine, risperidone
Flexible dose titrations to 'treat-to-symptoms'
Other Names:
  • Seroquel
  • Risperdal
Study Arms  ICMJE Active Comparator: 1
Quetiapine versus Risperidone
Intervention: Drug: quetiapine, risperidone
Publications * Nejtek VA, Avila M, Chen LA, Zielinski T, Djokovic M, Podawiltz A, Kaiser K, Bae S, Rush AJ. Do atypical antipsychotics effectively treat co-occurring bipolar disorder and stimulant dependence? A randomized, double-blind trial. J Clin Psychiatry. 2008 Aug;69(8):1257-66.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 3, 2008)
96
Original Enrollment  ICMJE
 (submitted: September 23, 2005)
100
Actual Study Completion Date  ICMJE November 2006
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years to 50 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00227123
Other Study ID Numbers  ICMJE 0602342
02T147
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE University of Texas Southwestern Medical Center
Collaborators  ICMJE
  • Stanley Medical Research Institute
  • University of North Texas Health Science Center
Investigators  ICMJE
Principal Investigator: Vicki A. Nejtek, Ph.D. University of North Texas Health Science Center
PRS Account University of Texas Southwestern Medical Center
Verification Date October 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP