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Seroquel Therapy for Substance Use Disorders Comorbid With Schizophrenia

This study has been completed.
Sponsor:
Collaborator:
AstraZeneca
Information provided by:
Creighton University
ClinicalTrials.gov Identifier:
NCT00208143
First received: September 13, 2005
Last updated: December 11, 2007
Last verified: October 2006
  Purpose

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.


Condition Intervention Phase
Schizophrenia
Schizoaffective Disorder
Substance Abuse
Substance Dependence
Drug: Quetiapine
Drug: Risperidone
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Seroquel (Quetiapine) Therapy for Schizophrenia and Schizoaffective Disorders and Comorbid Cocaine and/or Amphetamine Abuse/Dependence: A Comparative Study With Risperidone

Resource links provided by NLM:


Further study details as provided by Creighton University:

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.

Estimated Enrollment: 20
Study Start Date: November 2003
Study Completion Date: December 2005
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

Ages Eligible for Study:   19 Years to 65 Years   (Adult)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00208143

Locations
United States, Nebraska
Creighton University Psychiatry and Research Center
Omaha, Nebraska, United States, 68131
Sponsors and Collaborators
Creighton University
AstraZeneca
Investigators
Principal Investigator: Frederick Petty, MD, PhD Creighton University
  More Information

Responsible Party: Syed P. Sattar, M.D., Creighton University
ClinicalTrials.gov Identifier: NCT00208143     History of Changes
Other Study ID Numbers: IRUSQUET00292 
Study First Received: September 13, 2005
Last Updated: December 11, 2007
Health Authority: United States: Institutional Review Board

Keywords provided by Creighton University:
Cocaine Abuse
Cocaine Dependence
Amphetamine Abuse
Amphetamine Dependence
Schizophrenia
Comorbid
Schizoaffective Disorder

Additional relevant MeSH terms:
Disease
Schizophrenia
Psychotic Disorders
Substance-Related Disorders
Pathologic Processes
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Chemically-Induced Disorders
Quetiapine Fumarate
Risperidone
Cocaine
Amphetamine
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Psychotropic Drugs
Anesthetics, Local
Anesthetics
Sensory System Agents
Peripheral Nervous System Agents
Vasoconstrictor Agents
Dopamine Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Dopamine Agents
Neurotransmitter Agents
Serotonin Antagonists
Serotonin Agents

ClinicalTrials.gov processed this record on December 08, 2016