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CATIE- Schizophrenia Trial Clinical Trials Info presented on Clinical Trials Search isn't intended to be a substitute for certified medical advice, calls or professional assistance using a genuine dr.. We aren't physicians. Always confer with your dr. on CATIE- Schizophrenia Trial conditions. Clinical Trials Search.org is a website committed to listing clinical research studies in human subjects. CATIE- Schizophrenia Trial Clinical research trials and CATIE- Schizophrenia Trial medical trials happen in hundreds of localities throughout the U.S.A.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials typically measure the effectualness of new does drugs. The intent of the studies / undertakings is to answer particular human health questions. Clinical trials are a popular manner for physicians, government agencies, and private sector corporations to find cures for all kinds of circumstances, like CATIE- Schizophrenia Trial. CATIE- Schizophrenia Trial Clinical Trials and other clinical trials permit volunteers to acquire healthcare treatment options before they are available to the general public. Some times the subjects acquire professional assistance for free, and sometimes they are paid for their time. Sometimes there is a cost for a CATIE- Schizophrenia Trial clinical trial. Participants frequently obtain the most expert healthcare available for their CATIE- Schizophrenia Trial condition. Dangers are a reality, nevertheless, and can include more or frequent doctor calls, health risks (potentially life-jeopardizing), and/or the treatment being ineffectual. Trials are federally regulated with strict guidelines to protect clinical trials subjects.
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Home > "C" Clinical Trials Conditions > CATIE- Schizophrenia Trial  CATIE- Schizophrenia Trial
CATIE- Schizophrenia Trial
For Condition: Schizophrenia
Status: No longer recruiting
Sponsor(s): National Institute of Mental Health (NIMH) ,
Synopsis: 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.
Details: 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:
Study Type: Interventional, Treatment, Randomized, Double-Blind, Uncontrolled, Crossover Assignment, Safety/Efficacy Study
Minimum Age/Maximum Age: 18 Years/65 Years
Genders: Both
Protocol Entry 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
Total Enrollment: 1600
Location and Contact Information:
Overall Study Official:
JeffreyLieberman, Study Director, University of North Carolina
Burrell Behavioral Health-Cox North Hospital
Springfield, Missouri, 65802
United States
Baylor College of Medicine
Houston, Texas, 77030
United States
Mount Sinai Medical Center
New York City, New York, 10029
United States
Belmont Center for Comprehensive Treatment
Philadelphia, Pennsylvania, 19131
United States
Duke University Medical Center-John Umstead Hospital
Butner, North Carolina, 27509
United States
Harbor UCLA Research & Education Institute
Torrance, California, 90502
United States
Vanderbilt University Schizophrenia Research
Nashville, Tennessee, 37212
United States
Washington University School of Medicine
St. Louis, Missouri, 63112
United States
VA Puget Sound Health Care System
Tacoma, Washington, 98493
United States
University of Iowa Hospital
Iowa City, Iowa, 52242
United States
Life Management Center for MH/MR Services
El Paso, Texas, 98493
United States
Yale University/Connecticut Mental Health Center
New Haven, Connecticut, 06519
United States
Emory University School of Medicine
Atlanta, Georgia, 30319
United States
MHMRA of Harris County-Northwest Community Service Center
Houston, Texas, 77092
United States
University of Utah Medical Center
Salt Lake City, Utah, 84132
United States
University of North Carolina School of Medicine
Chapel Hill, North Carolina, 27599
United States
Eastern Pennsylvania Psychiatric Institute
Philadelphia, Pennsylvania, 19129
United States
SUNY Downstate Medical Center
Brooklyn, New York, 11203
United States
North East Ohio Health Services
Beachwood, Ohio, 44122
United States
University of Texas Southwestern Medical Center
Dallas, Texas, 75390
United States
Albuquerque VA Medical Center
Albuquerque, New Mexico, 87124
United States
St. Elizabeth's Medical Center
Boston, Massachusetts, 02135
United States
Louisiana State University Health Services Center
Shreveport, Louisiana, 71130
United States
The Queen's Medical Center
Honolulu, Hawaii, 96813
United States
LA County-University of Southern California Medical Center
Los Angeles, California, 90033
United States
University of Rochester Medical Center
Rochester, New York, 14620
United States
Northwestern Medical School Department of Psychiatry
Chicago, Illinois, 60634
United States
University of Mississippi VA Medical Center
Jackson, Mississippi, 39216
United States
VA Medical Center
Miami, Florida, 33125
United States
Stanford University School of Medicine
Stanford, California, 94305
United States
Psychiatric Research Institute, Outpatient Clinic
Wichita, Kansas, 67214
United States
Valley Mental Health Psychopharmacology Research Center
Salt Lake City, Utah, 84117
United States
University of Miami School of Medicine
Miami, Florida, 33316
United States
The Center for Health Care Services
San Antonio, Texas, 78208
United States
University of California, Irvine
Orange, California, 92868
United States
Dorothea Dix Hospital
Raleigh, North Carolina, 27603
United States
Synergy Clinical Research
Chula Vista, California, 91910
United States
Philadelphia VA Medical Center
Philadelphia, Pennsylvania, 19104
United States
Mount Sinai Medical Center-Bronx VA Medical Center
Bronx, New York, 10468
United States
Tri-County MHMR Services
Conroe, Texas, 77304
United States
Behavioral Health Center
Charlotte, North Carolina, 28203
United States
Staten Island University Hospital
Staten Island, New York, 10305
United States
University Of Massachusetts Memorial Health Care
Worcester, Massachusetts, 01605
United States
Veterans Affairs Medical Center
Charleston, South Carolina, 29401
United States
Massachusetts General Hospital-Freedom Trial Clinic Schizophrenia Program
Boston, Massachusetts, 02114
United States
Southern Illinois University School of Medicine
Springfield, Illinois, 62702
United States
Appalachian Psychiatric Healthcare System
Athens, Ohio, 45701
United States
Mental Health Advocates Inc.
Boca Raton, Florida, 33432
United States
University of Minnesota School of Medicine
Minneapolis, Minnesota, 55454
United States
Clinical Insights, Inc.
Glen Burnie, Maryland, 21061
United States
Corrigan Mental Health Center
Fall River, Massachusetts, 02720
United States
University of California,San Diego/VA Medical System
San Diego, California, 92161
United States
New Britain General Hospital
New Britain, Connecticut, 06050
United States
University of Missouri Kansas City Medical School
Kansas City, Missouri, 64108
United States
Additional Information:
Study ID Numbers: N01MH90001-SZ;
Study Start Date: December 2000
Record last reviewed: April 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00014001
Other Schizophrenia Studies:
1. Study of Three Doses of Aripiprazole in Patients with Acute Schizophrenia
2. The Assessment of a weight-gain agent for the Treatment of Olanzapine-Associated Anti-obesity Agent in Patients with Schizophrenia, Schizophreniform Disorder, Schizoaffective Disorder, and Bipolar I Disorder
3. I-123 Brain Studies of Serotonin Metabolism in Psychiatric Patients and Normal Volunteers
4. CATIE- Schizophrenia Trial
5. Glycine and D-Cycloserine in Schizophrenia
Related Studies:
Other Schizophrenia Clinical Trials
Other New York Clinical Trials
Other Rochester Clinical Trials
CATIE- Schizophrenia Trial
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