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CATIE- Schizophrenia Trial

Primary Purpose

Schizophrenia

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
perphenazine
olanzapine
quetiapine
risperidone
ziprasidone
clozapine
fluphenazine decanoate
Sponsored by
National Institute of Mental Health (NIMH)
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Schizophrenia focused on measuring Antipsychotic Treatment, Effectiveness

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Synergy Clinical Research
  • LA County-University of Southern California Medical Center
  • University of California, Irvine
  • University of California,San Diego/VA Medical System
  • Stanford University School of Medicine
  • Harbor UCLA Research & Education Institute
  • New Britain General Hospital
  • Yale University/Connecticut Mental Health Center
  • Mental Health Advocates Inc.
  • VA Medical Center
  • University of Miami School of Medicine
  • Emory University School of Medicine
  • The Queen's Medical Center
  • Northwestern Medical School Department of Psychiatry
  • Southern Illinois University School of Medicine
  • University of Iowa Hospital
  • Psychiatric Research Institute, Outpatient Clinic
  • Louisiana State University Health Services Center
  • Clinical Insights, Inc.
  • Massachusetts General Hospital-Freedom Trial Clinic Schizophrenia Program
  • St. Elizabeth's Medical Center
  • Corrigan Mental Health Center
  • University Of Massachusetts Memorial Health Care
  • University of Minnesota School of Medicine
  • University of Mississippi VA Medical Center
  • University of Missouri Kansas City Medical School
  • Burrell Behavioral Health-Cox North Hospital
  • Washington University School of Medicine
  • Albuquerque VA Medical Center
  • Mount Sinai Medical Center-Bronx VA Medical Center
  • SUNY Downstate Medical Center
  • Mount Sinai Medical Center
  • University of Rochester Medical Center
  • Staten Island University Hospital
  • Duke University Medical Center-John Umstead Hospital
  • University of North Carolina School of Medicine
  • Behavioral Health Center
  • Dorothea Dix Hospital
  • Appalachian Psychiatric Healthcare System
  • North East Ohio Health Services
  • Philadelphia VA Medical Center
  • Eastern Pennsylvania Psychiatric Institute
  • Belmont Center for Comprehensive Treatment
  • Veterans Affairs Medical Center
  • Vanderbilt University Schizophrenia Research
  • Tri-County MHMR Services
  • University of Texas Southwestern Medical Center
  • Life Management Center for MH/MR Services
  • Baylor College of Medicine
  • MHMRA of Harris County-Northwest Community Service Center
  • The Center for Health Care Services
  • Valley Mental Health Psychopharmacology Research Center
  • University of Utah Medical Center
  • VA Puget Sound Health Care System

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
April 6, 2001
Last Updated
June 16, 2015
Sponsor
National Institute of Mental Health (NIMH)
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1. Study Identification

Unique Protocol Identification Number
NCT00014001
Brief Title
CATIE- Schizophrenia Trial
Official Title
Comparative Effectiveness of Antipsychotic Medications in Patients With Schizophrenia (CATIE Schizophrenia Trial)
Study Type
Interventional

2. Study Status

Record Verification Date
October 2006
Overall Recruitment Status
Completed
Study Start Date
December 2000 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
December 2004 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
National Institute of Mental Health (NIMH)

4. Oversight

5. Study Description

Brief Summary
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.
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: 320 begin double-blind treatment with perphenazine (PER) 320 begin double-blind treatment with olanzapine (OLZ) 320 begin double-blind treatment with quetiapine (QUET) 320 begin double-blind treatment with risperidone (RIS) 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: 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%). 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia
Keywords
Antipsychotic Treatment, Effectiveness

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Masking
Double
Allocation
Randomized
Enrollment
1600 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
perphenazine
Intervention Type
Drug
Intervention Name(s)
olanzapine
Intervention Type
Drug
Intervention Name(s)
quetiapine
Intervention Type
Drug
Intervention Name(s)
risperidone
Intervention Type
Drug
Intervention Name(s)
ziprasidone
Intervention Type
Drug
Intervention Name(s)
clozapine
Intervention Type
Drug
Intervention Name(s)
fluphenazine decanoate

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jeffrey A Lieberman, MD
Organizational Affiliation
University of North Carolina
Official's Role
Study Director
Facility Information:
Facility Name
Synergy Clinical Research
City
Chula Vista
State/Province
California
ZIP/Postal Code
91910
Country
United States
Facility Name
LA County-University of Southern California Medical Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
Facility Name
University of California, Irvine
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
Facility Name
University of California,San Diego/VA Medical System
City
San Diego
State/Province
California
ZIP/Postal Code
92161
Country
United States
Facility Name
Stanford University School of Medicine
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States
Facility Name
Harbor UCLA Research & Education Institute
City
Torrance
State/Province
California
ZIP/Postal Code
90502
Country
United States
Facility Name
New Britain General Hospital
City
New Britain
State/Province
Connecticut
ZIP/Postal Code
06050
Country
United States
Facility Name
Yale University/Connecticut Mental Health Center
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06519
Country
United States
Facility Name
Mental Health Advocates Inc.
City
Boca Raton
State/Province
Florida
ZIP/Postal Code
33432
Country
United States
Facility Name
VA Medical Center
City
Miami
State/Province
Florida
ZIP/Postal Code
33125
Country
United States
Facility Name
University of Miami School of Medicine
City
Miami
State/Province
Florida
ZIP/Postal Code
33316
Country
United States
Facility Name
Emory University School of Medicine
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30319
Country
United States
Facility Name
The Queen's Medical Center
City
Honolulu
State/Province
Hawaii
ZIP/Postal Code
96813
Country
United States
Facility Name
Northwestern Medical School Department of Psychiatry
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60634
Country
United States
Facility Name
Southern Illinois University School of Medicine
City
Springfield
State/Province
Illinois
ZIP/Postal Code
62702
Country
United States
Facility Name
University of Iowa Hospital
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242
Country
United States
Facility Name
Psychiatric Research Institute, Outpatient Clinic
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67214
Country
United States
Facility Name
Louisiana State University Health Services Center
City
Shreveport
State/Province
Louisiana
ZIP/Postal Code
71130
Country
United States
Facility Name
Clinical Insights, Inc.
City
Glen Burnie
State/Province
Maryland
ZIP/Postal Code
21061
Country
United States
Facility Name
Massachusetts General Hospital-Freedom Trial Clinic Schizophrenia Program
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
St. Elizabeth's Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02135
Country
United States
Facility Name
Corrigan Mental Health Center
City
Fall River
State/Province
Massachusetts
ZIP/Postal Code
02720
Country
United States
Facility Name
University Of Massachusetts Memorial Health Care
City
Worcester
State/Province
Massachusetts
ZIP/Postal Code
01605
Country
United States
Facility Name
University of Minnesota School of Medicine
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55454
Country
United States
Facility Name
University of Mississippi VA Medical Center
City
Jackson
State/Province
Mississippi
ZIP/Postal Code
39216
Country
United States
Facility Name
University of Missouri Kansas City Medical School
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64108
Country
United States
Facility Name
Burrell Behavioral Health-Cox North Hospital
City
Springfield
State/Province
Missouri
ZIP/Postal Code
65802
Country
United States
Facility Name
Washington University School of Medicine
City
St. Louis
State/Province
Missouri
ZIP/Postal Code
63112
Country
United States
Facility Name
Albuquerque VA Medical Center
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87124
Country
United States
Facility Name
Mount Sinai Medical Center-Bronx VA Medical Center
City
Bronx
State/Province
New York
ZIP/Postal Code
10468
Country
United States
Facility Name
SUNY Downstate Medical Center
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11203
Country
United States
Facility Name
Mount Sinai Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Facility Name
University of Rochester Medical Center
City
Rochester
State/Province
New York
ZIP/Postal Code
14620
Country
United States
Facility Name
Staten Island University Hospital
City
Staten Island
State/Province
New York
ZIP/Postal Code
10305
Country
United States
Facility Name
Duke University Medical Center-John Umstead Hospital
City
Butner
State/Province
North Carolina
ZIP/Postal Code
27509
Country
United States
Facility Name
University of North Carolina School of Medicine
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599
Country
United States
Facility Name
Behavioral Health Center
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28203
Country
United States
Facility Name
Dorothea Dix Hospital
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27603
Country
United States
Facility Name
Appalachian Psychiatric Healthcare System
City
Athens
State/Province
Ohio
ZIP/Postal Code
45701
Country
United States
Facility Name
North East Ohio Health Services
City
Beachwood
State/Province
Ohio
ZIP/Postal Code
44122
Country
United States
Facility Name
Philadelphia VA Medical Center
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
Eastern Pennsylvania Psychiatric Institute
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19129
Country
United States
Facility Name
Belmont Center for Comprehensive Treatment
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19131
Country
United States
Facility Name
Veterans Affairs Medical Center
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29401
Country
United States
Facility Name
Vanderbilt University Schizophrenia Research
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37212
Country
United States
Facility Name
Tri-County MHMR Services
City
Conroe
State/Province
Texas
ZIP/Postal Code
77304
Country
United States
Facility Name
University of Texas Southwestern Medical Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390
Country
United States
Facility Name
Life Management Center for MH/MR Services
City
El Paso
State/Province
Texas
ZIP/Postal Code
98493
Country
United States
Facility Name
Baylor College of Medicine
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
MHMRA of Harris County-Northwest Community Service Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77092
Country
United States
Facility Name
The Center for Health Care Services
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78208
Country
United States
Facility Name
Valley Mental Health Psychopharmacology Research Center
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84117
Country
United States
Facility Name
University of Utah Medical Center
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84132
Country
United States
Facility Name
VA Puget Sound Health Care System
City
Tacoma
State/Province
Washington
ZIP/Postal Code
98493
Country
United States

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