New Antipsychotic Strategies: Quetiapine and Risperidone vs. Fluphenazine in Treatment Resistant Schizophrenia
Status:
Completed
Trial end date:
2004-11-01
Target enrollment:
Participant gender:
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.
Phase:
Phase 3
Details
Lead Sponsor:
University of Maryland University of Maryland, Baltimore