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Seroquel Therapy for Substance Use Disorders Comorbid With Schizophrenia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00208143
Recruitment Status : Completed
First Posted : September 21, 2005
Last Update Posted : December 13, 2007
Information provided by:
Creighton University

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.

Condition or disease Intervention/treatment Phase
Schizophrenia Schizoaffective Disorder Substance Abuse Substance Dependence Drug: Quetiapine Drug: Risperidone Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : November 2003
Actual Study Completion Date : December 2005

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Schizophrenia

Primary Outcome Measures :
  1. 50% or greater decrease in the drug use determined by the Time Line Follow Back method versus baseline.

Secondary Outcome Measures :
  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.

Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00208143

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

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Responsible Party: Syed P. Sattar, M.D., Creighton University Identifier: NCT00208143     History of Changes
Other Study ID Numbers: IRUSQUET00292
First Posted: September 21, 2005    Key Record Dates
Last Update Posted: December 13, 2007
Last Verified: October 2006
Keywords provided by Creighton University:
Cocaine Abuse
Cocaine Dependence
Amphetamine Abuse
Amphetamine Dependence
Schizoaffective Disorder
Additional relevant MeSH terms:
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Substance-Related Disorders
Psychotic Disorders
Pathologic Processes
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Chemically-Induced Disorders
Quetiapine Fumarate
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Dopamine Antagonists
Dopamine Agents
Anesthetics, Local
Sensory System Agents
Peripheral Nervous System Agents
Vasoconstrictor Agents
Dopamine Uptake Inhibitors
Neurotransmitter Uptake Inhibitors