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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00208143
Other study ID # IRUSQUET00292
Secondary ID
Status Completed
Phase Phase 4
First received September 13, 2005
Last updated December 11, 2007
Start date November 2003
Est. completion date December 2005

Study information

Verified date October 2006
Source Creighton University
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial Summary

It is hypothesized that the atypical antipsychotic, Seroquel, will cause significant reduction in drug and alcohol cravings in patients with schizophrenia and comorbid cocaine and/methamphetamine dependence compared to the atypical antipsychotic, risperidone (Risperdal).

Patients treated with Seroquel will have less use of cocaine and/or methamphetamine as measured by the Time Line Follow-back, over a 24-week follow-up period.


Description:

Schizophrenia is a serious mental illness that afflicts approximately 1% of the population (1). Often these patients have comorbid cocaine and amphetamine dependence, which increases the severity of psychotic symptoms associated with schizophrenia, decreases treatment compliance and worsens prognosis.

The treatment of schizophrenia with comorbid cocaine and/or amphetamine dependence is complex and involves adherence to psychiatric medications, most often antipsychotic agents, along with participation in specific substance abuse treatment such as structured living, attendance at self-help group meetings, individual and group therapy and a commitment to sobriety. In the absence of specific pharmacotherapy of cocaine and amphetamine dependence, various antipsychotic medications have been compared to see if they impact comorbid cocaine and amphetamine abuse in addition to their antipsychotic effects.

The primary objective of this study is to test whether Seroquel as a mono-therapy decreases cocaine and/or methamphetamine use in patients with schizophrenia as compared to risperidone.


Recruitment information / eligibility

Status Completed
Enrollment 20
Est. completion date December 2005
Est. primary completion date
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 19 Years to 65 Years
Eligibility Inclusion Criteria:

1. Ages 19 - 65.

2. Diagnosis of schizophrenia or schizoaffective disorder with comorbid cocaine and/or amphetamine abuse/dependence as confirmed by Structured Clinical Interview for DSM-IV.

3. Comorbid diagnoses of depression, anxiety and/or personality disorders are permitted.

4. Ability to provide signed informed consent.

5. Stable general medical health.

Exclusion Criteria:

1. Dangerous to self or others.

2. Pregnancy, inability or unwillingness to use approved methods of birth control.

3. Inability or unwillingness to provide signed informed consent.

4. Diagnosis of bipolar disorder, primary major depressive disorder (As major Axis I diagnosis).

5. Inability to attend outpatient research clinic.

6. Medical conditions, which would preclude use of Seroquel.

7. Absolute need for ongoing treatment with antipsychotic other than Seroquel.

8. Medical instability defined as likelihood of needing to change prescription medication during the course of the study.

9. Patients currently taking quetiapine or risperidone.

10. Patients with unsuccessful treatment with quetiapine or risperidone.

11. Subjects with a HAM-D score of =20 at screening.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Intervention

Drug:
Quetiapine

Risperidone


Locations

Country Name City State
United States Creighton University Psychiatry and Research Center Omaha Nebraska

Sponsors (2)

Lead Sponsor Collaborator
Creighton University AstraZeneca

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 50% or greater decrease in the drug use determined by the Time Line Follow Back method versus baseline.
Secondary Psychiatric symptoms will be assessed with the CGI, PANSS, BPRS, HAM-D, and HAM-A.Safety and tolerability will be assessed by patient and physician reported adverse events and AIMS.Quality of life will be assessed with QoLI.
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