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

Primary Purpose

Schizophrenia

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Quetiapine, Risperidone, Fluphenazine
Sponsored by
University of Maryland, Baltimore
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Schizophrenia

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Maryland Psychiatric Research Center

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
September 8, 2005
Last Updated
August 15, 2019
Sponsor
University of Maryland, Baltimore
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1. Study Identification

Unique Protocol Identification Number
NCT00161018
Brief Title
New Antipsychotic Strategies: Quetiapine and Risperidone vs. Fluphenazine in Treatment Resistant Schizophrenia
Study Type
Interventional

2. Study Status

Record Verification Date
August 2019
Overall Recruitment Status
Completed
Study Start Date
November 2003 (Actual)
Primary Completion Date
November 2004 (Actual)
Study Completion Date
November 2004 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Maryland, Baltimore

4. Oversight

5. Study Description

Brief Summary
The purpose of this study is to: 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. To evaluate the efficacy and safety of quetiapine (1200mg/day) in patients who have not responded to conventional and newer antipsychotics. 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. 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. To assess prolactin levels and to evaluate any relationship with sexual dysfunction and menstrual irregularities. 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. To measure changes in weight and health consequences associated with weight changes.
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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
150 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Quetiapine, Risperidone, Fluphenazine
Primary Outcome Measure Information:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert R Conley, MD
Organizational Affiliation
MPRC
Official's Role
Principal Investigator
Facility Information:
Facility Name
Maryland Psychiatric Research Center
City
Catonsville
State/Province
Maryland
ZIP/Postal Code
21228
Country
United States

12. IPD Sharing Statement

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

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