Seroquel Therapy for Substance Use Disorders Comorbid With Schizophrenia

December 11, 2007 updated by: Creighton University

Seroquel (Quetiapine) Therapy for Schizophrenia and Schizoaffective Disorders and Comorbid Cocaine and/or Amphetamine Abuse/Dependence: A Comparative Study With Risperidone

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment

20

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Nebraska
      • Omaha, Nebraska, United States, 68131
        • Creighton University Psychiatry and Research Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

17 years to 63 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
50% or greater decrease in the drug use determined by the Time Line Follow Back method versus baseline.

Secondary Outcome Measures

Outcome Measure
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Creighton University

Collaborators

AstraZeneca

Investigators

  • Principal Investigator: Frederick Petty, MD, PhD, Creighton University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2003

Study Completion (Actual)

December 1, 2005

Study Registration Dates

First Submitted

September 13, 2005

First Submitted That Met QC Criteria

September 13, 2005

First Posted (Estimate)

September 21, 2005

Study Record Updates

Last Update Posted (Estimate)

December 13, 2007

Last Update Submitted That Met QC Criteria

December 11, 2007

Last Verified

October 1, 2006

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRUSQUET00292

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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