SchizophreniaPhase 4NCT00014001
CATIE- Schizophrenia Trial
A Phase 4 study testing perphenazine, olanzapine and quetiapine in people with Schizophrenia, run by National Institute of Mental Health (NIMH) at 54 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Schizophrenia
- What is being tested?
- perphenazine, olanzapine and quetiapine
- How many people
- 1,600 participants
- Where
- 54 sitesUnited States
- Study dates
- Dec 2000to Dec 2004
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18-65 years old
- DSM-IV diagnosis of schizophrenia
- adequate capacity to consent
Who cannot join
- 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
Trial locations and contacts
54 sites in 1 country.
54 sites in 1 country
United States54 sites
Albuquerque VA Medical Center
Albuquerque, New Mexico, 87124
Appalachian Psychiatric Healthcare System
Athens, Ohio, 45701
Emory University School of Medicine
Atlanta, Georgia, 30319
North East Ohio Health Services
Beachwood, Ohio, 44122
Mental Health Advocates Inc.
Boca Raton, Florida, 33432
Massachusetts General Hospital-Freedom Trial Clinic Schizophrenia Program
Boston, Massachusetts, 02114
St. Elizabeth's Medical Center
Boston, Massachusetts, 02135
SUNY Downstate Medical Center
Brooklyn, New York, 11203
Duke University Medical Center-John Umstead Hospital
Butner, North Carolina, 27509
University of North Carolina School of Medicine
Chapel Hill, North Carolina, 27599
Veterans Affairs Medical Center
Charleston, South Carolina, 29401
Behavioral Health Center
Charlotte, North Carolina, 28203
Northwestern Medical School Department of Psychiatry
Chicago, Illinois, 60634
Synergy Clinical Research
Chula Vista, California, 91910
Tri-County MHMR Services
Conroe, Texas, 77304
University of Texas Southwestern Medical Center
Dallas, Texas, 75390
Life Management Center for MH/MR Services
El Paso, Texas, 98493
Corrigan Mental Health Center
Fall River, Massachusetts, 02720
Clinical Insights, Inc.
Glen Burnie, Maryland, 21061
The Queen's Medical Center
Honolulu, Hawaii, 96813
Baylor College of Medicine
Houston, Texas, 77030
MHMRA of Harris County-Northwest Community Service Center
Houston, Texas, 77092
University of Iowa Hospital
Iowa City, Iowa, 52242
University of Mississippi VA Medical Center
Jackson, Mississippi, 39216
University of Missouri Kansas City Medical School
Kansas City, Missouri, 64108
LA County-University of Southern California Medical Center
Los Angeles, California, 90033
VA Medical Center
Miami, Florida, 33125
University of Miami School of Medicine
Miami, Florida, 33316
University of Minnesota School of Medicine
Minneapolis, Minnesota, 55454
Vanderbilt University Schizophrenia Research
Nashville, Tennessee, 37212
New Britain General Hospital
New Britain, Connecticut, 06050
Yale University/Connecticut Mental Health Center
New Haven, Connecticut, 06519
Mount Sinai Medical Center
New York, New York, 10029
University of California, Irvine
Orange, California, 92868
Philadelphia VA Medical Center
Philadelphia, Pennsylvania, 19104
Eastern Pennsylvania Psychiatric Institute
Philadelphia, Pennsylvania, 19129
Belmont Center for Comprehensive Treatment
Philadelphia, Pennsylvania, 19131
Dorothea Dix Hospital
Raleigh, North Carolina, 27603
University of Rochester Medical Center
Rochester, New York, 14620
Valley Mental Health Psychopharmacology Research Center
Salt Lake City, Utah, 84117
University of Utah Medical Center
Salt Lake City, Utah, 84132
The Center for Health Care Services
San Antonio, Texas, 78208
University of California,San Diego/VA Medical System
San Diego, California, 92161
Louisiana State University Health Services Center
Shreveport, Louisiana, 71130
Southern Illinois University School of Medicine
Springfield, Illinois, 62702
Burrell Behavioral Health-Cox North Hospital
Springfield, Missouri, 65802
Washington University School of Medicine
St Louis, Missouri, 63112
Stanford University School of Medicine
Stanford, California, 94305
Staten Island University Hospital
Staten Island, New York, 10305
VA Puget Sound Health Care System
Tacoma, Washington, 98493
Mount Sinai Medical Center-Bronx VA Medical Center
The Bronx, New York, 10468
Harbor UCLA Research & Education Institute
Torrance, California, 90502
Psychiatric Research Institute, Outpatient Clinic
Wichita, Kansas, 67214
University Of Massachusetts Memorial Health Care
Worcester, Massachusetts, 01605
About this study
Official title: Comparative Effectiveness of Antipsychotic Medications in Patients With Schizophrenia (CATIE Schizophrenia Trial)
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.
Read the 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.
- Conditions
- Schizophrenia
- Being tested
- perphenazine, olanzapine, quetiapine, risperidone, ziprasidone
- Keywords
- Antipsychotic Treatment, Effectiveness
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
perphenazineDrug
olanzapineDrug
quetiapineDrug
risperidoneDrug
ziprasidoneDrug
clozapineDrug
fluphenazine decanoateDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2001 (estimated)
- Study startDec 2000
- Study completionDec 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (49)Papers the sponsor has linked to this study.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- More trials run by National Institute of Mental Health (NIMH)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Enrolment
- 1,600 participants
Sponsor and investigators
- Lead sponsor
- National Institute of Mental Health (NIMH)
- Sponsor type
- US National Institutes of Health
- Investigators
- Jeffrey A Lieberman, MD, Study director, University of North Carolina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00014001
- Sponsor's protocol ID
- N01 MH090001-06
- Other IDs
- N01MH90001-SZ, DSIR AT, N01MH90001, N01MH090001
- Status last verified
- Oct 2006
- First submitted
- 6 Apr 2001
- Last updated
- 17 Jun 2015
- Results posted
- No
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. doi: 10.1093/oxfordjournals.schbul.a006993.
PubMed 12908662Keefe 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. doi: 10.1093/oxfordjournals.schbul.a006990.
PubMed 12908660Lieberman 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. doi: 10.1093/oxfordjournals.schbul.a006979. No abstract available.
PubMed 12908656Rosenheck 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. doi: 10.1093/oxfordjournals.schbul.a006994.
PubMed 12908663Sernyak 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. doi: 10.1176/appi.ajp.160.2.310.
PubMed 12562578Stroup 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. doi: 10.1093/oxfordjournals.schbul.a006986.
PubMed 12908658Swartz 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. doi: 10.1093/oxfordjournals.schbul.a006989.
PubMed 12908659Stroup 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. doi: 10.1093/schbul/sbj026. Epub 2005 Nov 10.
PubMed 16282635Lieberman JA, Stroup TS, McEvoy JP, Swartz MS, Rosenheck RA, Perkins DO, Keefe RS, Davis SM, Davis CE, Lebowitz BD, Severe J, Hsiao JK; Clinical Antipsychotic Trials of Intervention Effectiveness (CATIE) Investigators. Effectiveness of antipsychotic drugs in patients with chronic schizophrenia. N Engl J Med. 2005 Sep 22;353(12):1209-23. doi: 10.1056/NEJMoa051688. Epub 2005 Sep 19.
PubMed 16172203McEvoy JP, Lieberman JA, Stroup TS, Davis SM, Meltzer HY, Rosenheck RA, Swartz MS, Perkins DO, Keefe RS, Davis CE, Severe J, Hsiao JK; CATIE Investigators. Effectiveness of clozapine versus olanzapine, quetiapine, and risperidone in patients with chronic schizophrenia who did not respond to prior atypical antipsychotic treatment. Am J Psychiatry. 2006 Apr;163(4):600-10. doi: 10.1176/ajp.2006.163.4.600.
PubMed 16585434Stroup TS, Lieberman JA, McEvoy JP, Swartz MS, Davis SM, Rosenheck RA, Perkins DO, Keefe RS, Davis CE, Severe J, Hsiao JK; CATIE Investigators. Effectiveness of olanzapine, quetiapine, risperidone, and ziprasidone in patients with chronic schizophrenia following discontinuation of a previous atypical antipsychotic. Am J Psychiatry. 2006 Apr;163(4):611-22. doi: 10.1176/ajp.2006.163.4.611.
PubMed 16585435Rosenheck RA, Leslie DL, Sindelar J, Miller EA, Lin H, Stroup TS, McEvoy J, Davis SM, Keefe RS, Swartz M, Perkins DO, Hsiao JK, Lieberman J; CATIE Study Investigators. Cost-effectiveness of second-generation antipsychotics and perphenazine in a randomized trial of treatment for chronic schizophrenia. Am J Psychiatry. 2006 Dec;163(12):2080-9. doi: 10.1176/ajp.2006.163.12.2080.
PubMed 17151158Essock SM, Covell NH, Davis SM, Stroup TS, Rosenheck RA, Lieberman JA. Effectiveness of switching antipsychotic medications. Am J Psychiatry. 2006 Dec;163(12):2090-5. doi: 10.1176/ajp.2006.163.12.2090.
PubMed 17151159Strobl EV, Kim S. Learning Outcomes That Maximally Differentiate Psychiatric Treatments. Int J Methods Psychiatr Res. 2026 Jun;35(2):e70074. doi: 10.1002/mpr.70074.
PubMed 42030496Fabbri C, Leggio GM, Drago F, Serretti A. Imputed expression of schizophrenia-associated genes and cognitive measures in patients with schizophrenia. Mol Genet Genomic Med. 2022 Jun;10(6):e1942. doi: 10.1002/mgg3.1942. Epub 2022 Apr 30.
PubMed 35488718
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Effectiveness of Antipsychotic Medications in Patients With Schizophrenia (CATIE Schizophrenia Trial)
- ClinicalTrials.gov ID
- NCT00014001
- Acronym / sponsor ID
- N01 MH090001-06
- Conditions
- Schizophrenia
- Keywords
- Antipsychotic Treatment, Effectiveness
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,600 participants
- Lead sponsor
- National Institute of Mental Health (NIMH)US National Institutes of Health
- Study start
- Dec 2000
- Study completion
- Dec 2004
- First posted
- 9 Apr 2001 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 18-65 years old
- DSM-IV diagnosis of schizophrenia
- adequate capacity to consent
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| perphenazine | Drug | – |
| olanzapine | Drug | – |
| quetiapine | Drug | – |
| risperidone | Drug | – |
| ziprasidone | Drug | – |
| clozapine | Drug | – |
| fluphenazine decanoate | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 2015.
- Background: PubMed 12908662Davis 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. doi: 10.1093/oxfordjournals.schbul.a006993.
- Background: PubMed 12908660Keefe 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. doi: 10.1093/oxfordjournals.schbul.a006990.
- Background: PubMed 12908656Lieberman 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. doi: 10.1093/oxfordjournals.schbul.a006979. No abstract available.
- Background: PubMed 12908663Rosenheck 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. doi: 10.1093/oxfordjournals.schbul.a006994.
- Background: PubMed 12562578Sernyak 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. doi: 10.1176/appi.ajp.160.2.310.
- Background: PubMed 12908658Stroup 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. doi: 10.1093/oxfordjournals.schbul.a006986.
- Background: PubMed 12908659Swartz 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. doi: 10.1093/oxfordjournals.schbul.a006989.
- Background: PubMed 16282635Stroup 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. doi: 10.1093/schbul/sbj026. Epub 2005 Nov 10.
- Results publication: PubMed 16172203Lieberman JA, Stroup TS, McEvoy JP, Swartz MS, Rosenheck RA, Perkins DO, Keefe RS, Davis SM, Davis CE, Lebowitz BD, Severe J, Hsiao JK; Clinical Antipsychotic Trials of Intervention Effectiveness (CATIE) Investigators. Effectiveness of antipsychotic drugs in patients with chronic schizophrenia. N Engl J Med. 2005 Sep 22;353(12):1209-23. doi: 10.1056/NEJMoa051688. Epub 2005 Sep 19.
- Results publication: PubMed 16585434McEvoy JP, Lieberman JA, Stroup TS, Davis SM, Meltzer HY, Rosenheck RA, Swartz MS, Perkins DO, Keefe RS, Davis CE, Severe J, Hsiao JK; CATIE Investigators. Effectiveness of clozapine versus olanzapine, quetiapine, and risperidone in patients with chronic schizophrenia who did not respond to prior atypical antipsychotic treatment. Am J Psychiatry. 2006 Apr;163(4):600-10. doi: 10.1176/ajp.2006.163.4.600.
- Results publication: PubMed 16585435Stroup TS, Lieberman JA, McEvoy JP, Swartz MS, Davis SM, Rosenheck RA, Perkins DO, Keefe RS, Davis CE, Severe J, Hsiao JK; CATIE Investigators. Effectiveness of olanzapine, quetiapine, risperidone, and ziprasidone in patients with chronic schizophrenia following discontinuation of a previous atypical antipsychotic. Am J Psychiatry. 2006 Apr;163(4):611-22. doi: 10.1176/ajp.2006.163.4.611.
- Results publication: PubMed 17151158Rosenheck RA, Leslie DL, Sindelar J, Miller EA, Lin H, Stroup TS, McEvoy J, Davis SM, Keefe RS, Swartz M, Perkins DO, Hsiao JK, Lieberman J; CATIE Study Investigators. Cost-effectiveness of second-generation antipsychotics and perphenazine in a randomized trial of treatment for chronic schizophrenia. Am J Psychiatry. 2006 Dec;163(12):2080-9. doi: 10.1176/ajp.2006.163.12.2080.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jeffrey A Lieberman, MD study director
University of North Carolina
54 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing perphenazine, olanzapine and quetiapine in people with Schizophrenia, run by National Institute of Mental Health (NIMH) at 54 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 54 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00014001, which also lists 49 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jun 2015.