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

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.

Completed

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Key information

Conditions

Schizophrenia Mental Disorders Schizophrenia Spectrum and Other Psychotic Disorders

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Maryland Psychiatric Research Center

Catonsville, Maryland, 21228, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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 criteria

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.

Treatment and study plan

Quetiapine, Risperidone, Fluphenazine

Drug

Primary outcomes

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

Sponsors and collaborators

Lead sponsor

University of Maryland, Baltimore

Other

Registry information

Important dates

Study start: 2003
Primary completion: 2004
Study completion: 2004
First posted: Sep 12, 2005
Registry last updated: Aug 19, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed