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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00161018
Recruitment Status : Completed
First Posted : September 12, 2005
Last Update Posted : August 19, 2019
Sponsor:
Information provided by (Responsible Party):
MPRC, University of Maryland, Baltimore

Brief 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.

Condition or disease Intervention/treatment Phase
Schizophrenia Drug: Quetiapine, Risperidone, Fluphenazine Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Actual Study Start Date : November 2003
Actual Primary Completion Date : November 2004
Actual Study Completion Date : November 2004

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Schizophrenia




Primary Outcome Measures :
  1. 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


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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:

    1. Persistent positive psychotic symptoms.
    2. Current presence of at least a moderately severe illness as rated by the total BPRS.
    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.

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00161018


Locations
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United States, Maryland
Maryland Psychiatric Research Center
Catonsville, Maryland, United States, 21228
Sponsors and Collaborators
University of Maryland, Baltimore
Investigators
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Principal Investigator: Robert R Conley, MD MPRC
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Responsible Party: MPRC, PI, University of Maryland, Baltimore
ClinicalTrials.gov Identifier: NCT00161018    
Other Study ID Numbers: H-20725
First Posted: September 12, 2005    Key Record Dates
Last Update Posted: August 19, 2019
Last Verified: August 2019
Additional relevant MeSH terms:
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Schizophrenia
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Risperidone
Quetiapine Fumarate
Fluphenazine
Fluphenazine depot
Fluphenazine enanthate
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Dopamine Antagonists
Dopamine Agents
Antidepressive Agents