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	Treatment or Intervention	Phase
Schizophrenia	Drug: perphenazine  Drug: olanzapine  Drug: quetiapine  Drug: risperidone  Drug: ziprasidone  Drug: clozapine  Drug: fluphenazine decanoate	Phase IV

Further Study Details: 

Expected Total Enrollment:  1600

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.

Ages Eligible for Study:  18 Years   -   65 Years,  Genders Eligible for Study:  Both

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

California
      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
Connecticut
      Yale University/Connecticut Mental Health Center, New Haven,  Connecticut,  06519,  United States
      New Britain General Hospital, New Britain,  Connecticut,  06050,  United States
Florida
      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
Georgia
      Emory University School of Medicine, Atlanta,  Georgia,  30319,  United States
Hawaii
      The Queen's Medical Center, Honolulu,  Hawaii,  96813,  United States
Illinois
      Northwestern Medical School Department of Psychiatry, Chicago,  Illinois,  60634,  United States
      Southern Illinois University School of Medicine, Springfield,  Illinois,  62702,  United States
Iowa
      University of Iowa Hospital, Iowa City,  Iowa,  52242,  United States
Kansas
      Psychiatric Research Institute, Outpatient Clinic, Wichita,  Kansas,  67214,  United States
Louisiana
      Louisiana State University Health Services Center, Shreveport,  Louisiana,  71130,  United States
Maryland
      Clinical Insights, Inc., Glen Burnie,  Maryland,  21061,  United States
Massachusetts
      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
Minnesota
      University of Minnesota School of Medicine, Minneapolis,  Minnesota,  55454,  United States
Mississippi
      University of Mississippi VA Medical Center, Jackson,  Mississippi,  39216,  United States
Missouri
      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
New Mexico
      Albuquerque VA Medical Center, Albuquerque,  New Mexico,  87124,  United States
New York
      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
North Carolina
      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
Ohio
      Appalachian Psychiatric Healthcare System, Athens,  Ohio,  45701,  United States
      North East Ohio Health Services, Beachwood,  Ohio,  44122,  United States
Pennsylvania
      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
South Carolina
      Veterans Affairs Medical Center, Charleston,  South Carolina,  29401,  United States
Tennessee
      Vanderbilt University Schizophrenia Research, Nashville,  Tennessee,  37212,  United States
Texas
      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
Utah
      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
Washington
      VA Puget Sound Health Care System, Tacoma,  Washington,  98493,  United States

Study chairs or principal investigators

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

Study ID Numbers:  N01MH90001-SZ
Record last reviewed:  September 2004
Last Updated:  October 13, 2004
Record first received:  April 6, 2001
ClinicalTrials.gov Identifier:  NCT00014001
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08