Trial record 1 of 3 for:    CATIE Schizophrenia
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CATIE- Schizophrenia Trial

This study has been completed.
Sponsor:
Information provided by:
National Institute of Mental Health (NIMH)
ClinicalTrials.gov Identifier:
NCT00014001
First received: April 6, 2001
Last updated: April 16, 2014
Last verified: October 2006
  Purpose

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.


Condition Intervention Phase
Schizophrenia
Drug: perphenazine
Drug: olanzapine
Drug: quetiapine
Drug: risperidone
Drug: ziprasidone
Drug: clozapine
Drug: fluphenazine decanoate
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Comparative Effectiveness of Antipsychotic Medications in Patients With Schizophrenia (CATIE Schizophrenia Trial)

Resource links provided by NLM:


Further study details as provided by National Institute of Mental Health (NIMH):

Estimated Enrollment: 1600
Study Start Date: December 2000
Estimated Study Completion Date: December 2004
Detailed Description:

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 months:

  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 IA.

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 clozapine.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion

  • 18-65 years old
  • DSM-IV diagnosis of schizophrenia
  • adequate capacity to consent

Exclusion

  • 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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00014001

  Hide Study Locations
Locations
United States, California
Synergy Clinical Research
Chula Vista, California, United States, 91910
LA County-University of Southern California Medical Center
Los Angeles, California, United States, 90033
University of California, Irvine
Orange, California, United States, 92868
University of California,San Diego/VA Medical System
San Diego, California, United States, 92161
Stanford University School of Medicine
Stanford, California, United States, 94305
Harbor UCLA Research & Education Institute
Torrance, California, United States, 90502
United States, Connecticut
New Britain General Hospital
New Britain, Connecticut, United States, 06050
Yale University/Connecticut Mental Health Center
New Haven, Connecticut, United States, 06519
United States, Florida
Mental Health Advocates Inc.
Boca Raton, Florida, United States, 33432
University of Miami School of Medicine
Miami, Florida, United States, 33316
VA Medical Center
Miami, Florida, United States, 33125
United States, Georgia
Emory University School of Medicine
Atlanta, Georgia, United States, 30319
United States, Hawaii
The Queen's Medical Center
Honolulu, Hawaii, United States, 96813
United States, Illinois
Northwestern Medical School Department of Psychiatry
Chicago, Illinois, United States, 60634
Southern Illinois University School of Medicine
Springfield, Illinois, United States, 62702
United States, Iowa
University of Iowa Hospital
Iowa City, Iowa, United States, 52242
United States, Kansas
Psychiatric Research Institute, Outpatient Clinic
Wichita, Kansas, United States, 67214
United States, Louisiana
Louisiana State University Health Services Center
Shreveport, Louisiana, United States, 71130
United States, Maryland
Clinical Insights, Inc.
Glen Burnie, Maryland, United States, 21061
United States, Massachusetts
Massachusetts General Hospital-Freedom Trial Clinic Schizophrenia Program
Boston, Massachusetts, United States, 02114
St. Elizabeth's Medical Center
Boston, Massachusetts, United States, 02135
Corrigan Mental Health Center
Fall River, Massachusetts, United States, 02720
University Of Massachusetts Memorial Health Care
Worcester, Massachusetts, United States, 01605
United States, Minnesota
University of Minnesota School of Medicine
Minneapolis, Minnesota, United States, 55454
United States, Mississippi
University of Mississippi VA Medical Center
Jackson, Mississippi, United States, 39216
United States, Missouri
University of Missouri Kansas City Medical School
Kansas City, Missouri, United States, 64108
Burrell Behavioral Health-Cox North Hospital
Springfield, Missouri, United States, 65802
Washington University School of Medicine
St. Louis, Missouri, United States, 63112
United States, New Mexico
Albuquerque VA Medical Center
Albuquerque, New Mexico, United States, 87124
United States, New York
Mount Sinai Medical Center-Bronx VA Medical Center
Bronx, New York, United States, 10468
SUNY Downstate Medical Center
Brooklyn, New York, United States, 11203
Mount Sinai Medical Center
New York, New York, United States, 10029
University of Rochester Medical Center
Rochester, New York, United States, 14620
Staten Island University Hospital
Staten Island, New York, United States, 10305
United States, North Carolina
Duke University Medical Center-John Umstead Hospital
Butner, North Carolina, United States, 27509
University of North Carolina School of Medicine
Chapel Hill, North Carolina, United States, 27599
Behavioral Health Center
Charlotte, North Carolina, United States, 28203
Dorothea Dix Hospital
Raleigh, North Carolina, United States, 27603
United States, Ohio
Appalachian Psychiatric Healthcare System
Athens, Ohio, United States, 45701
North East Ohio Health Services
Beachwood, Ohio, United States, 44122
United States, Pennsylvania
Eastern Pennsylvania Psychiatric Institute
Philadelphia, Pennsylvania, United States, 19129
Philadelphia VA Medical Center
Philadelphia, Pennsylvania, United States, 19104
Belmont Center for Comprehensive Treatment
Philadelphia, Pennsylvania, United States, 19131
United States, South Carolina
Veterans Affairs Medical Center
Charleston, South Carolina, United States, 29401
United States, Tennessee
Vanderbilt University Schizophrenia Research
Nashville, Tennessee, United States, 37212
United States, Texas
Tri-County MHMR Services
Conroe, Texas, United States, 77304
University of Texas Southwestern Medical Center
Dallas, Texas, United States, 75390
Life Management Center for MH/MR Services
El Paso, Texas, United States, 98493
MHMRA of Harris County-Northwest Community Service Center
Houston, Texas, United States, 77092
Baylor College of Medicine
Houston, Texas, United States, 77030
The Center for Health Care Services
San Antonio, Texas, United States, 78208
United States, Utah
Valley Mental Health Psychopharmacology Research Center
Salt Lake City, Utah, United States, 84117
University of Utah Medical Center
Salt Lake City, Utah, United States, 84132
United States, Washington
VA Puget Sound Health Care System
Tacoma, Washington, United States, 98493
Sponsors and Collaborators
Investigators
Study Director: Jeffrey A Lieberman, MD University of North Carolina
  More Information

Publications:

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

ClinicalTrials.gov Identifier: NCT00014001     History of Changes
Other Study ID Numbers: N01 MH090001-06, N01MH90001-SZ, DSIR AT
Study First Received: April 6, 2001
Last Updated: April 16, 2014
Health Authority: United States: Federal Government

Keywords provided by National Institute of Mental Health (NIMH):
Antipsychotic Treatment
Effectiveness

Additional relevant MeSH terms:
Schizophrenia
Schizophrenia and Disorders with Psychotic Features
Mental Disorders
Antipsychotic Agents
Fluphenazine
Fluphenazine depot
Fluphenazine enanthate
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

ClinicalTrials.gov processed this record on October 19, 2014