CATIE- Schizophrenia Trial

June 16, 2015 updated by: National Institute of Mental Health (NIMH)

Comparative Effectiveness of Antipsychotic Medications in Patients With Schizophrenia (CATIE Schizophrenia Trial)

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment

1600

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Institute of Mental Health (NIMH)

Investigators

  • Study Director: Jeffrey A Lieberman, MD, University of North Carolina

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2000

Study Completion

December 1, 2004

Study Registration Dates

First Submitted

April 6, 2001

First Submitted That Met QC Criteria

April 7, 2001

First Posted (Estimate)

April 9, 2001

Study Record Updates

Last Update Posted (Estimate)

June 17, 2015

Last Update Submitted That Met QC Criteria

June 16, 2015

Last Verified

October 1, 2006

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • N01 MH090001-06
  • DSIR AT (NCT00590863)
  • N01MH90001-SZ

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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