drugset / Trial / NCT00161018

New Antipsychotic Strategies: Quetiapine and Risperidone vs. Fluphenazine in Treatment Resistant Schizophrenia

NCT00161018

Phase 3 Completed 150 enrolled University of Maryland, Baltimore
RandomizedParallel-groupDouble-blindTreatment

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 (10-15mg/day), a high potency typical antipsychotic in patients who meet the DSM IV criteria for schizophrenia. 2. To evaluate the efficacy and safety of quetiapine (1200mg/day) in patients who have not responded to conventional and newer antipsychotics. 3. To evaluate the effectiveness of quetiapine (300-500mg/day), and risperidone (3-5mg/day) compared to each other and fluphenazine (10-15mg/day) in the treatment of hostility and aggression in treatment-resistant schizophrenic patients. 4. To evaluate the effectiveness of quetiapine (300-500mg/day) and risperidone (3-5mg/day) compared to each other and fluphenazine (10-15mg/day) on rates of discharge, quality of life, and independent living skills. 5. To assess prolactin levels and to evaluate any relationship with sexual dysfunction and menstrual irregularities. 6. To evaluate the possible differential impact of treatment conditions on cognitive functioning including measures of attention, motor speed, problem solving, verbal and visual memory, and verbal processing speed. 7. To measure changes in weight and health consequences associated with weight changes.

Timeline

Start
2003-11
Primary completion
2004-11
Completion
2004-11

Drugs

EvaluationDrugModalityDoseRoute
Subject Fluphenazine Small molecule 10 mg
Subject Fluphenazine Small molecule 15 mg
Subject Quetiapine Small molecule 300 mg
Subject Quetiapine Small molecule 500 mg
Subject Quetiapine Small molecule 1200 mg
Subject Risperidone Other / unclassified 3 mg
Subject Risperidone Other / unclassified 4 mg
Subject Risperidone Other / unclassified 5 mg

Indications