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Sponsored by: |
University of Maryland |
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Information provided by: | University of Maryland |
ClinicalTrials.gov Identifier: | NCT00161018 |
The purpose of this study is to:
Condition | Intervention | Phase |
---|---|---|
Schizophrenia |
Drug: Quetiapine, Risperidone, Fluphenazine |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Dose Comparison, Parallel Assignment |
Estimated Enrollment: | 150 |
Study Start Date: | November 2003 |
Study Completion Date: | November 2004 |
This is a three arm multi-center randomized double-blind study. After open label treatment with each individual being optimized with routine antipsychotic treatment for 4-6 weeks to prospectively establish lack of response to conventional antipsychotic therapy, approximately 180 patients with schizophrenia who are experiencing clinically significant psychotic symptoms will be recruited (minimum 150 enrolled) in the double-blind period of the study. All participants will sign consent forms before participating in this research study. If participants choose to enroll in the high dose quetiapine arm (period IIIb), they will sign an additional consent form before entering period IIIb.
Ages Eligible for Study: | 18 Years to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Subjects must meet retrospective criteria for treatment-resistance as defined:
Exclusion Criteria:
United States, Maryland | |
Maryland Psychiatric Research Center | |
Catonsville, Maryland, United States, 21228 |
Principal Investigator: | Robert R Conley, MD | MPRC |
Study ID Numbers: | H-20725 |
Study First Received: | September 8, 2005 |
Last Updated: | October 8, 2008 |
ClinicalTrials.gov Identifier: | NCT00161018 |
Health Authority: | United States: Institutional Review Board; United States: Food and Drug Administration |
Schizophrenia Quetiapine Dopamine Mental Disorders Fluphenazine depot |
Risperidone Psychotic Disorders Fluphenazine Serotonin Schizophrenia and Disorders with Psychotic Features |
Neurotransmitter Agents Tranquilizing Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Psychotropic Drugs Central Nervous System Depressants Dopamine Antagonists |
Antipsychotic Agents Pharmacologic Actions Serotonin Antagonists Serotonin Agents Therapeutic Uses Dopamine Agents Central Nervous System Agents |