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

NCT ID: NCT00227123

Last Updated: 2008-01-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 96 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2002-10-31
• Study Completion Date: 2006-11-30

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.

Conditions

Bipolar Disorder; Cocaine Dependence; Methamphetamine Dependence

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

1

Quetiapine versus Risperidone

Group Type: ACTIVE_COMPARATOR

quetiapine, risperidone

Intervention Type: DRUG

Flexible dose titrations to 'treat-to-symptoms'

Interventions

quetiapine, risperidone

Flexible dose titrations to 'treat-to-symptoms'

Intervention Type: DRUG

Other Intervention Names

Seroquel; Risperdal

Eligibility 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.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Stanley Medical Research Institute

OTHER

Sponsor Role: collaborator

University of North Texas Health Science Center

OTHER

Sponsor Role: collaborator

University of Texas Southwestern Medical Center

OTHER

Sponsor Role: lead

Principal Investigators

Vicki A. Nejtek, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

University of North Texas Health Science Center

Locations

University of Texas Southwestern Medical Center at Dallas

Dallas, Texas, United States

Universty of North Texas Health Science Center

Fort Worth, Texas, United States

Countries

United States

References

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. doi: 10.4088/jcp.v69n0808.

Reference Type: DERIVED

PMID: 18681757 (View on PubMed)

Other Identifiers

02T147

Identifier Type: -

Identifier Source: secondary_id

0602342

Identifier Type: -

Identifier Source: org_study_id