Seroquel Therapy for Substance Use Disorders Comorbid With Schizophrenia
Information source: Creighton University
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Schizophrenia; Schizoaffective Disorder; Substance Abuse; Substance Dependence
Intervention: Quetiapine (Drug); Risperidone (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: Creighton University Official(s) and/or principal investigator(s):
Frederick Petty, MD, PhD, Principal Investigator, Affiliation: Creighton University
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.
Clinical Details
Official title: Seroquel (Quetiapine) Therapy for Schizophrenia and Schizoaffective Disorders and Comorbid Cocaine and/or Amphetamine Abuse/Dependence: A Comparative Study With Risperidone
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: 50% or greater decrease in the drug use determined by the Time Line Follow Back method versus baseline.
Secondary outcome: 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.
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.
Eligibility
Minimum age: 19 Years.
Maximum age: 65 Years.
Gender(s): Both.
Criteria:
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.
Locations and Contacts
Creighton University Psychiatry and Research Center, Omaha, Nebraska 68131, United States
Additional Information
Starting date: November 2003
Last updated: December 11, 2007
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