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Seroquel Therapy for Substance Use Disorders Comorbid With Schizophrenia

NCT ID: NCT00208143

Last Updated: 2007-12-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-11-30

Study Completion Date

2005-12-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Schizophrenia Schizoaffective Disorder Substance Abuse Substance Dependence

Keywords

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Cocaine Abuse Cocaine Dependence Amphetamine Abuse Amphetamine Dependence Schizophrenia Comorbid Schizoaffective Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Quetiapine

Intervention Type DRUG

Risperidone

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

19 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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AstraZeneca

INDUSTRY

Sponsor Role collaborator

Creighton University

OTHER

Sponsor Role lead

Responsible Party

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Creighton University

Principal Investigators

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Frederick Petty, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Creighton University

Locations

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Creighton University Psychiatry and Research Center

Omaha, Nebraska, United States

Site Status

Countries

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United States

Other Identifiers

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IRUSQUET00292

Identifier Type: -

Identifier Source: org_study_id