Seroquel Therapy for Substance Use Disorders Comorbid With Schizophrenia

Schizophrenia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00208143
• Other study ID #: IRUSQUET00292
• 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
• 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

Related Conditions & MeSH terms

• Psychotic Disorders
• Schizoaffective Disorder
• Schizophrenia
• Substance Abuse
• Substance Dependence
• Substance-Related Disorders

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.