Seroquel Therapy for Substance Use Disorders Comorbid With Schizophrenia

Back to results

Primary Purpose

Status

Completed

Phase

Phase 4

Locations

United States

Study Type

Interventional

Intervention

Quetiapine

Risperidone

About this trial

This is an interventional treatment trial for Schizophrenia focused on measuring Cocaine Abuse, Cocaine Dependence, Amphetamine Abuse, Amphetamine Dependence, Schizophrenia, Comorbid, Schizoaffective Disorder

Eligibility Criteria

19 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Ages 19 - 65. Diagnosis of schizophrenia or schizoaffective disorder with comorbid cocaine and/or amphetamine abuse/dependence as confirmed by Structured Clinical Interview for DSM-IV. Comorbid diagnoses of depression, anxiety and/or personality disorders are permitted. Ability to provide signed informed consent. Stable general medical health. Exclusion Criteria: Dangerous to self or others. Pregnancy, inability or unwillingness to use approved methods of birth control. Inability or unwillingness to provide signed informed consent. Diagnosis of bipolar disorder, primary major depressive disorder (As major Axis I diagnosis). Inability to attend outpatient research clinic. Medical conditions, which would preclude use of Seroquel. Absolute need for ongoing treatment with antipsychotic other than Seroquel. Medical instability defined as likelihood of needing to change prescription medication during the course of the study. Patients currently taking quetiapine or risperidone. Patients with unsuccessful treatment with quetiapine or risperidone. Subjects with a HAM-D score of ≥20 at screening.

Sites / Locations

Creighton University Psychiatry and Research Center

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.

Full Information

NCT ID

NCT00208143

First Posted

September 13, 2005

Last Updated

December 11, 2007

Sponsor

Creighton University

Collaborators

AstraZeneca

1. Study Identification

Unique Protocol Identification Number

NCT00208143

Brief Title

Seroquel Therapy for Substance Use Disorders Comorbid With Schizophrenia

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2006

Overall Recruitment Status

Completed

Study Start Date

November 2003 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

December 2005 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Creighton University

Collaborators

AstraZeneca

4. Oversight

Data Monitoring Committee

No

5. Study Description

Brief 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Schizophrenia, Schizoaffective Disorder, Substance Abuse, Substance Dependence

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

20 (false)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

Quetiapine

Intervention Type

Drug

Intervention Name(s)

Risperidone

Primary Outcome Measure Information:

Title

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

Secondary Outcome Measure Information:

Title

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.

10. Eligibility

Sex

All

Minimum Age & Unit of Time

19 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Ages 19 - 65. Diagnosis of schizophrenia or schizoaffective disorder with comorbid cocaine and/or amphetamine abuse/dependence as confirmed by Structured Clinical Interview for DSM-IV. Comorbid diagnoses of depression, anxiety and/or personality disorders are permitted. Ability to provide signed informed consent. Stable general medical health. Exclusion Criteria: Dangerous to self or others. Pregnancy, inability or unwillingness to use approved methods of birth control. Inability or unwillingness to provide signed informed consent. Diagnosis of bipolar disorder, primary major depressive disorder (As major Axis I diagnosis). Inability to attend outpatient research clinic. Medical conditions, which would preclude use of Seroquel. Absolute need for ongoing treatment with antipsychotic other than Seroquel. Medical instability defined as likelihood of needing to change prescription medication during the course of the study. Patients currently taking quetiapine or risperidone. Patients with unsuccessful treatment with quetiapine or risperidone. Subjects with a HAM-D score of ≥20 at screening.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Frederick Petty, MD, PhD

Organizational Affiliation

Creighton University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Creighton University Psychiatry and Research Center

City

Omaha

State/Province

Nebraska

ZIP/Postal Code

68131

Country

United States

Schizophrenia, Schizoaffective Disorder, Substance Abuse

About this trial

Eligibility Criteria

Sites / Locations

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial