Status:
COMPLETED
New Antipsychotic Strategies: Quetiapine and Risperidone vs. Fluphenazine in Treatment Resistant Schizophrenia
Lead Sponsor:
University of Maryland, Baltimore
Conditions:
Schizophrenia
Eligibility:
All Genders
18-65 years
Phase:
PHASE3
Brief Summary
The purpose of this study is to: 1. Evaluate the efficacy and safety of the new antipsychotics, quetiapine (300-500mg/day) and risperidone (3-4mg/day) compared to each other and to fluphenazine (10-1...
Detailed Description
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 esta...
Eligibility Criteria
Inclusion
- Males and Females, between ages 18 and 65 year sof age.
- Females of childbearing potential must agree to use medically accepted means of contraception.
- A diagnosis of schizophrenia according to the DSM-IV.
- Subjects must meet retrospective criteria for treatment-resistance as defined:
- Persistent positive psychotic symptoms.
- Current presence of at least a moderately severe illness as rated by the total BPRS.
- Persistence of illness- No evidence of good functioning in the last five years.
- Drug-refectory condition defined as at least two periods of treatment in the preceding significant symptom relief.
- Subjects must been judged competent to consent by the ESC evaluation and provide voluntary informed consent.
- Subjects must be reliable. They must agree to cooperate with all tests and examinations required by the protocol.
- Patients msut have a normal ophthalmoscopic exam within 6 months of a full eye exam if any lense abnormality prior to entering study.
Exclusion
- Females who are either pregnant or lactating.
- Serious medical illness including hepatic, renal, gastroenterologic, respiratory, cardiovascular, endocrinologic, neurologic, immunologic, or hematologic disease such that hospitalization for the disease is anticipated within three months or death is anticipated with three years.
- History of severe allergies or multiple adverse drug reactions.
- DSM-IV substance abuse or dependence within the past month.
- Any DSM-IV organic mental disorder.
- Judged clinically to be at serious suicidal risk.
- Definitive failure to show clinically significant response (improved in CGI score of at least 1 point) to and adequate trial of clozapine (600mg/day for at least 6 weeks)
- Uncontrolled seizures within the past 6 months.
Key Trial Info
Start Date :
November 1 2003
Trial Type :
INTERVENTIONAL
End Date :
November 1 2004
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT00161018
Start Date
November 1 2003
End Date
November 1 2004
Last Update
August 19 2019
Active Locations (1)
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1
Maryland Psychiatric Research Center
Catonsville, Maryland, United States, 21228