CATIE- Schizophrenia Trial

Condition(s) targeted: Schizophrenia

Intervention: perphenazine (Drug); olanzapine (Drug); quetiapine (Drug); risperidone (Drug); ziprasidone (Drug); clozapine (Drug); fluphenazine decanoate (Drug)

Phase: Phase 4

Status: Completed

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

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.

Minimum age: 18 Years. Maximum age: 65 Years. Gender(s): 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

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.

Related publications:

Davis SM, Koch GG, Davis CE, LaVange LM. Statistical approaches to effectiveness measurement and outcome-driven re-randomizations in the Clinical Antipsychotic Trials of Intervention Effectiveness (CATIE) studies. Schizophr Bull. 2003;29(1):73-80.

Keefe RS, Mohs RC, Bilder RM, Harvey PD, Green MF, Meltzer HY, Gold JM, Sano M. Neurocognitive assessment in the Clinical Antipsychotic Trials of Intervention Effectiveness (CATIE) project schizophrenia trial: development, methodology, and rationale. Schizophr Bull. 2003;29(1):45-55.

Lieberman JA, Stroup TS. Guest editors' introduction: what can large pragmatic clinical trials do for public mental health care? Schizophr Bull. 2003;29(1):1-6. No abstract available.

Rosenheck R, Doyle J, Leslie D, Fontana A. Changing environments and alternative perspectives in evaluating the cost-effectiveness of new antipsychotic drugs. Schizophr Bull. 2003;29(1):81-93.

Schneider LS, Ismail MS, Dagerman K, Davis S, Olin J, McManus D, Pfeiffer E, Ryan JM, Sultzer DL, Tariot PN. Clinical Antipsychotic Trials of Intervention Effectiveness (CATIE): Alzheimer's disease trial. Schizophr Bull. 2003;29(1):57-72.

Sernyak MJ, Leslie D, Rosenheck R. Use of system-wide outcomes monitoring data to compare the effectiveness of atypical neuroleptic medications. Am J Psychiatry. 2003 Feb;160(2):310-5.

Stroup TS, McEvoy JP, Swartz MS, Byerly MJ, Glick ID, Canive JM, McGee MF, Simpson GM, Stevens MC, Lieberman JA. The National Institute of Mental Health Clinical Antipsychotic Trials of Intervention Effectiveness (CATIE) project: schizophrenia trial design and protocol development. Schizophr Bull. 2003;29(1):15-31.

Swartz MS, Perkins DO, Stroup TS, McEvoy JP, Nieri JM, Haak DC. Assessing clinical and functional outcomes in the Clinical Antipsychotic Trials of Intervention Effectiveness (CATIE) schizophrenia trial. Schizophr Bull. 2003;29(1):33-43.

Stroup TS, Appelbaum PS. Evaluation of "subject advocate" procedures in the Clinical Antipsychotic Trials of Intervention Effectiveness (CATIE) schizophrenia study. Schizophr Bull. 2006 Jan;32(1):147-52. Epub 2005 Nov 10.

Starting date: December 2000
Ending date: December 2004
Last updated: July 2, 2007