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

This study has been completed.
Sponsor:
Information provided by:
University of Maryland
ClinicalTrials.gov Identifier:
NCT00161018
First received: September 8, 2005
Last updated: October 8, 2008
Last verified: October 2008
History of Changes
  Purpose

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 Intervention Phase
Schizophrenia
 Drug: Quetiapine, Risperidone, Fluphenazine
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment

Resource links provided by NLM:

MedlinePlus related topics: Schizophrenia
U.S. FDA Resources

Further study details as provided by University of Maryland:

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

Estimated Enrollment: 150
Study Start Date: November 2003
Study Completion Date: November 2004
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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00161018

Locations
United States, Maryland
Maryland Psychiatric Research Center
Catonsville, Maryland, United States, 21228
Sponsors and Collaborators
University of Maryland
Investigators
Principal Investigator: Robert R Conley, MD MPRC
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00161018     History of Changes
Other Study ID Numbers: H-20725
Study First Received: September 8, 2005
Last Updated: October 8, 2008
Health Authority: United States: Institutional Review Board
United States: Food and Drug Administration

Additional relevant MeSH terms:
Schizophrenia
Schizophrenia and Disorders with Psychotic Features
Mental Disorders
Fluphenazine
Fluphenazine depot
Fluphenazine enanthate
Risperidone
Quetiapine
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
 Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Psychotropic Drugs
Dopamine Antagonists
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Serotonin Antagonists
Serotonin Agents

ClinicalTrials.gov processed this record on June 17, 2013