Seroquel Therapy for Substance Use Disorders Comorbid With Schizophrenia - Full Text View

Sponsor:	Creighton University
Collaborator:	AstraZeneca
Information provided by:	Creighton University
ClinicalTrials.gov Identifier:	NCT00208143

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 IV

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:

MedlinePlus related topics: Methamphetamine Schizophrenia

Drug Information available for: Methamphetamine hydrochloride Cocaine hydrochloride Amphetamine sulfate Risperidone Quetiapine Quetiapine fumarate Amphetamine Methamphetamine

U.S. FDA Resources

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
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

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.

Contacts and Locations

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

No publications provided

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:

Psychotic Disorders
Schizophrenia
Substance-Related Disorders
Amphetamine-Related Disorders
Schizophrenia and Disorders with Psychotic Features
Mental Disorders
Amphetamine
Risperidone
Quetiapine
Central Nervous System Stimulants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Sympathomimetics

Autonomic Agents
Peripheral Nervous System Agents
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Adrenergic Agents
Adrenergic Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Dopamine Uptake Inhibitors
Serotonin Antagonists
Serotonin Agents
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs

ClinicalTrials.gov processed this record on February 09, 2012