Clinical trial NCT00014001: CATIE- Schizophrenia Trial
Official title: Comparative Effectiveness of Antipsychotic Medications in Patients With Schizophrenia (CATIE Schizophrenia Trial)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Schizophrenia
Keywords: Antipsychotic Treatment
Effectiveness
Lead sponsor: National Institute of Mental Health (NIMH)
Sponsor class: NIH
First posted: 2001-04-09
Enrollment: 1600
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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:

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 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

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Chula Vista
country: United States
facility: Synergy Clinical Research
state: California
city: Los Angeles
country: United States
facility: LA County-University of Southern California Medical Center
state: California
city: Orange
country: United States
facility: University of California, Irvine
state: California
city: San Diego
country: United States
facility: University of California,San Diego/VA Medical System
state: California
city: Stanford
country: United States
facility: Stanford University School of Medicine
state: California
city: Torrance
country: United States
facility: Harbor UCLA Research & Education Institute
state: California
city: New Britain
country: United States
facility: New Britain General Hospital
state: Connecticut
city: New Haven
country: United States
facility: Yale University/Connecticut Mental Health Center
state: Connecticut
city: Boca Raton
country: United States
facility: Mental Health Advocates Inc.
state: Florida
city: Miami
country: United States
facility: VA Medical Center
state: Florida
city: Miami
country: United States
facility: University of Miami School of Medicine
state: Florida
city: Atlanta
country: United States
facility: Emory University School of Medicine
state: Georgia
city: Honolulu
country: United States
facility: The Queen's Medical Center
state: Hawaii
city: Chicago
country: United States
facility: Northwestern Medical School Department of Psychiatry
state: Illinois
city: Springfield
country: United States
facility: Southern Illinois University School of Medicine
state: Illinois
city: Iowa City
country: United States
facility: University of Iowa Hospital
state: Iowa
city: Wichita
country: United States
facility: Psychiatric Research Institute, Outpatient Clinic
state: Kansas
city: Shreveport
country: United States
facility: Louisiana State University Health Services Center
state: Louisiana
city: Glen Burnie
country: United States
facility: Clinical Insights, Inc.
state: Maryland
city: Boston
country: United States
facility: Massachusetts General Hospital-Freedom Trial Clinic Schizophrenia Program
state: Massachusetts
city: Boston
country: United States
facility: St. Elizabeth's Medical Center
state: Massachusetts
city: Fall River
country: United States
facility: Corrigan Mental Health Center
state: Massachusetts
city: Worcester
country: United States
facility: University Of Massachusetts Memorial Health Care
state: Massachusetts
city: Minneapolis
country: United States
facility: University of Minnesota School of Medicine
state: Minnesota
city: Jackson
country: United States
facility: University of Mississippi VA Medical Center
state: Mississippi
city: Kansas City
country: United States
facility: University of Missouri Kansas City Medical School
state: Missouri
city: Springfield
country: United States
facility: Burrell Behavioral Health-Cox North Hospital
state: Missouri
city: St. Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
city: Albuquerque
country: United States
facility: Albuquerque VA Medical Center
state: New Mexico
city: Bronx
country: United States
facility: Mount Sinai Medical Center-Bronx VA Medical Center
state: New York
city: Brooklyn
country: United States
facility: SUNY Downstate Medical Center
state: New York
city: New York
country: United States
facility: Mount Sinai Medical Center
state: New York
city: Rochester
country: United States
facility: University of Rochester Medical Center
state: New York
city: Staten Island
country: United States
facility: Staten Island University Hospital
state: New York
city: Butner
country: United States
facility: Duke University Medical Center-John Umstead Hospital
state: North Carolina
city: Chapel Hill
country: United States
facility: University of North Carolina School of Medicine
state: North Carolina
city: Charlotte
country: United States
facility: Behavioral Health Center
state: North Carolina
city: Raleigh
country: United States
facility: Dorothea Dix Hospital
state: North Carolina
city: Athens
country: United States
facility: Appalachian Psychiatric Healthcare System
state: Ohio
city: Beachwood
country: United States
facility: North East Ohio Health Services
state: Ohio
city: Philadelphia
country: United States
facility: Philadelphia VA Medical Center
state: Pennsylvania
city: Philadelphia
country: United States
facility: Eastern Pennsylvania Psychiatric Institute
state: Pennsylvania
city: Philadelphia
country: United States
facility: Belmont Center for Comprehensive Treatment
state: Pennsylvania
city: Charleston
country: United States
facility: Veterans Affairs Medical Center
state: South Carolina
city: Nashville
country: United States
facility: Vanderbilt University Schizophrenia Research
state: Tennessee
city: Conroe
country: United States
facility: Tri-County MHMR Services
state: Texas
city: Dallas
country: United States
facility: University of Texas Southwestern Medical Center
state: Texas
city: El Paso
country: United States
facility: Life Management Center for MH/MR Services
state: Texas
city: Houston
country: United States
facility: Baylor College of Medicine
state: Texas
city: Houston
country: United States
facility: MHMRA of Harris County-Northwest Community Service Center
state: Texas
city: San Antonio
country: United States
facility: The Center for Health Care Services
state: Texas
city: Salt Lake City
country: United States
facility: Valley Mental Health Psychopharmacology Research Center
state: Utah
city: Salt Lake City
country: United States
facility: University of Utah Medical Center
state: Utah
city: Tacoma
country: United States
facility: VA Puget Sound Health Care System
state: Washington
Study officials:
affiliation: University of North Carolina
name: Jeffrey A Lieberman, MD
role: STUDY_DIRECTOR
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