Status:
COMPLETED
Efficacy of Quetiapine in the Treatment of Patients With Schizophrenia and a Comorbid Substance Use Disorder
Lead Sponsor:
Dartmouth-Hitchcock Medical Center
Collaborating Sponsors:
Augusta University
AstraZeneca
Conditions:
Schizophrenia
Schizoaffective Disorder
Eligibility:
All Genders
18-65 years
Phase:
PHASE4
Brief Summary
The purpose of this study is to examine the efficacy of quetiapine (Seroquel) in reducing substance use in persons diagnosed with schizophrenia. The primary hypothesis is that quetiapine treatment wil...
Detailed Description
Comorbid alcohol/substance use disorder (SUD) in schizophrenia is a major concern, both in view of the high frequency of SUD among patients with schizophrenia and the difficulty in managing such patie...
Eligibility Criteria
Inclusion
- Age 18-65
- Schizophrenia or schizoaffective disorder
- Meets Structured Clinical Interview for Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (SCID) criteria for a substance use disorder (alcohol use disorder \[AUD\]; abuse or dependence)
- Active substance use on at least 8 days during the 4 weeks prior to randomization.
- Current treatment with antipsychotic medication.
- Able to provide informed consent, or in the case of patients with legal court appointed guardians willing to give assent, with the consent of the guardian.
- Not actively suicidal.
Exclusion
- Current treatment with, decanoate antipsychotic, clozapine, or doses of quetiapine not approved by the team of investigators. Individuals treated with depot antipsychotic must wait until the end of their injection cycle before starting on study medication.
- Currently pregnant, planning to become pregnant, or unwilling to use an acceptable form of birth control.
- Currently residing in a residential program designed to treat substance use disorders.
- Treatment at baseline with a psychotropic agent proposed to curtail substance use.
- Patients who, in the opinion of the investigator, are judged unsuitable to participate in the study.
- Unable to take part in the assessments in a meaningful way
- Hypersensitivity/intolerance to quetiapine
- Serious, unstable medical condition
- Participation in clinical trial of an investigational drug within 30 days of baseline visit, or concurrent participation in a treatment study of a psychosocial intervention
Key Trial Info
Start Date :
March 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2008
Estimated Enrollment :
23 Patients enrolled
Trial Details
Trial ID
NCT00156715
Start Date
March 1 2004
End Date
October 1 2008
Last Update
March 14 2018
Active Locations (4)
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1
Medical College of Georgia
Augusta, Georgia, United States, 30912
2
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, United States, 03756
3
West Central Behavioral Health
Lebanon, New Hampshire, United States, 03766
4
Mental Health Center of Greater Manchester
Manchester, New Hampshire, United States, 03101