New Antipsychotic Strategies: Quetiapine and Risperidone vs. Fluphenazine in Treatment Resistant Schizophrenia
Information source: University of Maryland
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Schizophrenia
Intervention: Quetiapine, Risperidone, Fluphenazine (Drug)
Phase: Phase 3
Status: Active, not recruiting
Sponsored by: University of Maryland
Official(s) and/or principal investigator(s):
Robert R Conley, MD, Principal Investigator, Affiliation: MPRC
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
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
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.
Study design: Treatment, Randomized, Double-Blind, Dose Comparison, Parallel Assignment
Primary outcome: To evaluate the efficacy and safety of the new antipsychotics, quetiapine(300-500mg/day) and risperidone(3-5mg/day) compared to each other and to fluphenazine(10-15mg/day), a high potency typical antipsychotic
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.
Minimum age: 18 Years.
Maximum age: 65 Years.
- Males and Females, between ages 18 and 65 year sof age.
- Females of childbearing potential must agree to use medically accepted means of
- A diagnosis of schizophrenia according to the DSM-IV.
- Subjects must meet retrospective criteria for treatment-resistance as defined:
1. Persistent positive psychotic symptoms.
2. Current presence of at least a moderately severe illness as rated by the total
3. Persistence of illness- No evidence of good functioning in the last five years.
4. 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.
- 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.
Locations and Contacts
Maryland Psychiatric Research Center, Catonsville, Maryland 21228, United States
Starting date: November 2003
Ending date: November 2004
Last updated: June 26, 2007