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

September 23, 2005
January 3, 2008
October 2002
Not Provided
  • Mood symptom improvement. [ Time Frame: Baseline to exit ]
  • Cocaine or methamphetamine cravings and use. [ Time Frame: Baseline to exit ]
  • Manic and depressive symptom improvement.
  • Reduced drug craving and use.
Complete list of historical versions of study NCT00227123 on ClinicalTrials.gov Archive Site
Body Mass Index [ Time Frame: Baseline to Exit ]
  • Treatment retention.
  • Neurocognitive improvement.
Not Provided
Not Provided
 
A Randomized Control Trial Comparing Quetiapine to Risperidone in Bipolar Disorder With Stimulant Dependence
A Randomized Control Trial Comparing Quetiapine to Risperidone in Bipolar Disorder Outpatients With Current Stimulant Dependence

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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Bipolar Disorder
  • Cocaine Dependence
  • Methamphetamine Dependence
Drug: quetiapine, risperidone
Flexible dose titrations to 'treat-to-symptoms'
Other Names:
  • Seroquel
  • Risperdal
Active Comparator: 1
Quetiapine versus Risperidone
Intervention: Drug: quetiapine, risperidone
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.
 
Completed
96
November 2006
Not Provided

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.
Both
20 Years to 50 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00227123
0602342, 02T147
No
Not Provided
University of Texas Southwestern Medical Center
  • Stanley Medical Research Institute
  • University of North Texas Health Science Center
Principal Investigator: Vicki A. Nejtek, Ph.D. University of North Texas Health Science Center
University of Texas Southwestern Medical Center
October 2007

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