CATIE- Schizophrenia Trial
Information source: National Institute of Mental Health (NIMH)
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Schizophrenia
Intervention: perphenazine (Drug); olanzapine (Drug); quetiapine (Drug); risperidone (Drug); ziprasidone (Drug); clozapine (Drug); fluphenazine decanoate (Drug)
Phase: Phase 4
Sponsored by: National Institute of Mental Health (NIMH)
Official(s) and/or principal investigator(s):
Jeffrey A Lieberman, MD, Study Director, Affiliation: University of North Carolina
The CATIE Schizophrenia Trial is part of the Clinical Antipsychotic Trials of Intervention
Effectiveness (CATIE) Project. The schizophrenia trial is being conducted to determine the
long-term effects and usefulness of antipsychotic medications in persons with schizophrenia.
It is designed for people with schizophrenia who may benefit from a medication change. The
study involves the newer atypical antipsychotics (olanzapine, quetiapine, risperidone,
clozapine, and ziprasidone)and the typical antipsychotics (perphenazine and fluphenazine
decanoate). All participants will receive an initial comprehensive medical and psychiatric
evaluation and will be closely followed throughout the study. For most participants the study
will last up to 18 months. Everyone in the study will be offered an educational program about
schizophrenia and family members will be encouraged to participate.
Official title: Comparative Effectiveness of Antipsychotic Medications in Patients With Schizophrenia (CATIE Schizophrenia Trial)
Study design: Treatment, Randomized, Double-Blind, Uncontrolled, Crossover Assignment, Safety/Efficacy Study
This trial will consist of 1600 patients with schizophrenia for whom a medication change may
be indicated for reasons of limited efficacy or tolerability. All patients will receive some
psychosocial treatment through study participation. Research participants and their family
members will be offered psychosocial interventions directed at improving patient and family
understanding of the illness, decreasing the burden of illness in the family, maximizing
treatment adherence, minimizing relapse, enhancing access to a range of community-based
rehabilitative services and improving study retention.
Phase I: Patients will be randomly assigned to one of five treatment conditions for up to 18
1. 320 begin double-blind treatment with perphenazine (PER)
2. 320 begin double-blind treatment with olanzapine (OLZ)
3. 320 begin double-blind treatment with quetiapine (QUET)
4. 320 begin double-blind treatment with risperidone (RIS)
5. 220 begin double-blind treatment with ziprasidone (ZIP)
Phase IA: 100 patients screened and found to have tardive dyskinesia who would otherwise be
eligible for the study will be randomly assigned to one of the four atypical drugs in Phase
Phase IB: Patients who fail treatment with perphenazine in Phase I will be randomly assigned
to olanzapine, quetiapine, or risperidone in Phase IB.
Phase II: Patients who discontinue their initial assigned atypical antipsychotic treatment
in Phase I, IA, or IB for any non-administrative reason will proceed to their second assigned
treatment (third for Phase IB patients) and will be followed for up to the remainder of their
18-month participation, as follows:
1. Patients originally assigned to one of the newer atypical antipsychotics who discontinue
due to efficacy failure will be randomly assigned to double-blind treatment with one of
the other two newer atypical antipsychotics (OLZ, RIS, QUET) which they had not
previously received (50%) or with open label clozapine (50%).
2. Patients originally assigned to one of the newer atypical antipsychotics who discontinue
due to tolerability failure will be randomly assigned to double-blind treatment with one
of the other newer atypical antipsychotics (OLZ, RIS, QUET) which they had not
previously received (50%), or with ziprasidone (50%). Until ziprasidone is activated,
all patients will be assigned to one of the other atypical antipsychotics.
Phase II will last at least 6 months, even if that means participants stay in the study for
more than 18 months
Phase III: Patients who discontinue Phase II will be recommended open treatment with the
preferred regimen based on their treatment history in the study. The treatment options
include clozapine, newer atypical antipsychotic (olanzapine, risperidone, quetiapine,
ziprazidone, and aripiprazole), fluphenazine decanoate, perphenazine, and dual antipsychotic
therapy using two of these drugs.
Note: All treatments will be double-blinded in treatment Phases I and II except for
Minimum age: 18 Years.
Maximum age: 65 Years.
- 18-65 years old
- DSM-IV diagnosis of schizophrenia
- adequate capacity to consent
- Intolerance or failure to respond to one of the treatments
- Diagnoses of schizoaffective disorder, mental retardation, pervasive developmental
disorder, delirium, dementia, amnesia
- First episode of schizophrenia
- Women currently pregnant or breast-feeding
Locations and Contacts
Synergy Clinical Research, Chula Vista, California 91910, United States
Stanford University School of Medicine, Stanford, California 94305, United States
Harbor UCLA Research & Education Institute, Torrance, California 90502, United States
University of California, Irvine, Orange, California 92868, United States
University of California,San Diego/VA Medical System, San Diego, California 92161, United States
LA County-University of Southern California Medical Center, Los Angeles, California 90033, United States
Yale University/Connecticut Mental Health Center, New Haven, Connecticut 06519, United States
New Britain General Hospital, New Britain, Connecticut 06050, United States
Mental Health Advocates Inc., Boca Raton, Florida 33432, United States
University of Miami School of Medicine, Miami, Florida 33316, United States
VA Medical Center, Miami, Florida 33125, United States
Emory University School of Medicine, Atlanta, Georgia 30319, United States
The Queen's Medical Center, Honolulu, Hawaii 96813, United States
Northwestern Medical School Department of Psychiatry, Chicago, Illinois 60634, United States
Southern Illinois University School of Medicine, Springfield, Illinois 62702, United States
University of Iowa Hospital, Iowa City, Iowa 52242, United States
Psychiatric Research Institute, Outpatient Clinic, Wichita, Kansas 67214, United States
Louisiana State University Health Services Center, Shreveport, Louisiana 71130, United States
Clinical Insights, Inc., Glen Burnie, Maryland 21061, United States
Massachusetts General Hospital-Freedom Trial Clinic Schizophrenia Program, Boston, Massachusetts 02114, United States
St. Elizabeth's Medical Center, Boston, Massachusetts 02135, United States
University Of Massachusetts Memorial Health Care, Worcester, Massachusetts 01605, United States
Corrigan Mental Health Center, Fall River, Massachusetts 02720, United States
University of Minnesota School of Medicine, Minneapolis, Minnesota 55454, United States
University of Mississippi VA Medical Center, Jackson, Mississippi 39216, United States
Burrell Behavioral Health-Cox North Hospital, Springfield, Missouri 65802, United States
University of Missouri Kansas City Medical School, Kansas City, Missouri 64108, United States
Washington University School of Medicine, St. Louis, Missouri 63112, United States
Albuquerque VA Medical Center, Albuquerque, New Mexico 87124, United States
Staten Island University Hospital, Staten Island, New York 10305, United States
Mount Sinai Medical Center-Bronx VA Medical Center, Bronx, New York 10468, United States
Mount Sinai Medical Center, New York, New York 10029, United States
SUNY Downstate Medical Center, Brooklyn, New York 11203, United States
University of Rochester Medical Center, Rochester, New York 14620, United States
Dorothea Dix Hospital, Raleigh, North Carolina 27603, United States
University of North Carolina School of Medicine, Chapel Hill, North Carolina 27599, United States
Duke University Medical Center-John Umstead Hospital, Butner, North Carolina 27509, United States
Behavioral Health Center, Charlotte, North Carolina 28203, United States
Appalachian Psychiatric Healthcare System, Athens, Ohio 45701, United States
North East Ohio Health Services, Beachwood, Ohio 44122, United States
Eastern Pennsylvania Psychiatric Institute, Philadelphia, Pennsylvania 19129, United States
Philadelphia VA Medical Center, Philadelphia, Pennsylvania 19104, United States
Belmont Center for Comprehensive Treatment, Philadelphia, Pennsylvania 19131, United States
Veterans Affairs Medical Center, Charleston, South Carolina 29401, United States
Vanderbilt University Schizophrenia Research, Nashville, Tennessee 37212, United States
Tri-County MHMR Services, Conroe, Texas 77304, United States
University of Texas Southwestern Medical Center, Dallas, Texas 75390, United States
MHMRA of Harris County-Northwest Community Service Center, Houston, Texas 77092, United States
Life Management Center for MH/MR Services, El Paso, Texas 98493, United States
The Center for Health Care Services, San Antonio, Texas 78208, United States
Baylor College of Medicine, Houston, Texas 77030, United States
Valley Mental Health Psychopharmacology Research Center, Salt Lake City, Utah 84117, United States
University of Utah Medical Center, Salt Lake City, Utah 84132, United States
VA Puget Sound Health Care System, Tacoma, Washington 98493, United States
Click here to find more information about this study.
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Starting date: December 2000
Ending date: December 2004
Last updated: July 2, 2007