Seroquel Therapy for Substance Use Disorders Comorbid With Schizophrenia

NCT00208143 | Completed Phase 4

• 1 other identifier: IRUSQUET00292
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Schizophrenia; Schizoaffective Disorder; Substance Abuse; Substance Dependence

Keywords

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

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (1)

• 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.

Interventions

Quetiapine DRUG

Risperidone DRUG

Eligibility Criteria

• Age: 19 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Creighton University: lead
• AstraZeneca: collaborator

Study Sites (1)

Creighton University Psychiatry and Research Center

Omaha, Nebraska, 68131, United States

Location

MeSH Terms

Conditions

Schizophrenia; Psychotic Disorders; Substance-Related Disorders; Cocaine-Related Disorders; Amphetamine-Related Disorders

Interventions

Quetiapine Fumarate; Risperidone

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders; Chemically-Induced Disorders

Intervention Hierarchy (Ancestors)

Dibenzothiazepines; Thiazepines; Thiepins; Sulfur Compounds; Organic Chemicals; Heterocyclic Compounds, 3-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring

Study Officials

• Frederick Petty, MD, PhD

  Creighton University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 13, 2005
• First Posted: September 21, 2005
• Study Start: November 1, 2003
• Study Completion: December 1, 2005
• Last Updated: December 13, 2007

Record last verified: 2006-10

Locations

US (1)