Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
450 participants
INTERVENTIONAL
2001-03-31
2004-10-31
Brief Summary
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Detailed Description
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Phase I: In the initial treatment phase (Phase 1), patients will be randomized to one of the three atypical antipsychotics or placebo in the ratio 100:100:100:150 respectively. After two weeks, the investigator can move the patient to the next phase because of lack of efficacy or tolerability. At week 12, the investigator can decide whether the current medication is sufficiently optimal or it would be more beneficial to try another randomized medication.
Phase 2: Phase 2 starts when the patient is randomized to a second medication, i.e., olanzapine, quetiapine, risperidone, or citalopram. Patients will be randomized from an antipsychotic treatment to another antipsychotic treatment or citalopram in the ratio 3:3:2, or from placebo to an antipsychotic treatment or citalopram in the ratio 1:1:1:3 respectively. Therefore, 50% of patients who took placebo in Phase 1 will be randomized to an antipsychotic in Phase 2, and 50% will be randomized to citalopram in Phase 2. After the initial two weeks in Phase 2, the investigator can move the patient to the next phase, due to lack of efficacy or tolerability. After the patient has been on the Phase 2 study drug for approximately 12 weeks, the investigator can decide whether the current medication is sufficiently optimal or whether it would be more beneficial to try another randomized medication.
Phase 3: Phase 3 is randomized open-label treatment of one of the medications not previously received, i.e., olanzapine, quetiapine, risperidone, or citalopram. Treatment failures to the second treatment can be switched to a third open-label treatment. During Phase 3 patients will be maintained on their treatments openly and managed clinically until week 36.
If the investigator determines that the patient's response is not sufficiently optimal to the randomized open-label medication, then after the first two weeks of Phase 3, the investigator can prescribe another medication (of the investigator's choice) to the patient. If this occurs then patients are classed as being in the Open-Choice Phase.
Open-Choice Phase: The Open-Choice Phase can be entered at anytime during the 36-week study and directly from any of the three phases. There are four reasons a patient can enter the open choice phase:
* Withdrawal from Phase 1 or Phase 2 with the patient or surrogate decision-maker refusing to proceed to the next randomized phase;
* Withdrawal from Phase 3;
* Withdrawal from current study drug from any of the three previous phases due to antipsychotic medication no longer being required in the opinion of the investigator; or
* Withdrawal due to concomitant treatment with an exclusionary medication.
The Open-Choice Phase is designed to keep patients monitored in the trial for the 36-week duration.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Interventions
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Olanzapine
Quetiapine
Risperidone
Citalopram
Eligibility Criteria
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Inclusion Criteria
* Ambulatory, Outpatients who have an informant living/visiting at least 8 hours/week over 3-4 days.
* Presence of delusions, hallucinations, agitation impacting functioning and requiring medication treatment
* Agitation or psychotic symptoms began after signs or symptoms of dementia
Exclusion (prospective participants must not:)
* Be benefiting from psychotropic medication, antidepressants or anticonvulsants
* Be diagnosed with schizophrenia, schizoaffective disorder, delusional disorder or mood disorder with psychotic features.
* Have severe or unstable medical illness requiring active treatment
* Have hypersensitivity or intolerance of any of the study medications
ALL
No
Sponsors
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National Institute of Mental Health (NIMH)
NIH
Principal Investigators
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Lon Schneider, MD
Role: PRINCIPAL_INVESTIGATOR
University of Southern California
Pierre Tariot, MD
Role: PRINCIPAL_INVESTIGATOR
University of Rochester
Locations
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Tuscaloosa VA Medical Center
Tuscaloosa, Alabama, United States
University of California, Irvine Medical Center
Irvine, California, United States
University of Southern California Dept of Psychiatry& Behavioral Sciences
Los Angeles, California, United States
University of California, Los Angeles, VA Medical Center
Los Angeles, California, United States
University of California-San Diego, VA Medical Center
San Diego, California, United States
Stanford University School of Medicine
Stanford, California, United States
Yale University School of Medicine
New Haven, Connecticut, United States
Mental Health Advocates, Inc.
Boca Raton, Florida, United States
Berma Research Group
Hialeah, Florida, United States
University of South Florida Suncoast Gerontology Center
Tampa, Florida, United States
Palm Beach Neurology/Premiere Research Institute
West Palm Beach, Florida, United States
Emory University - Wesley Woods Health Center
Atlanta, Georgia, United States
University of Hawaii
Honolulu, Hawaii, United States
Northwestern University Medical School
Chicago, Illinois, United States
Southern Illinois School of Medicine
Springfield, Illinois, United States
University of Iowa College of Medicine
Iowa City, Iowa, United States
Louisiana State University Health Sciences Center
Shreveport, Louisiana, United States
Johns Hopkins University
Baltimore, Maryland, United States
Millennium Psychiatric Associates
St Louis, Missouri, United States
University of Medicine and Dentistry of New Jersey
Piscataway, New Jersey, United States
University of Medicine and Dentistry of New Jersey-Stratford
Stratford, New Jersey, United States
Mount Sinai School of Medicine
New York, New York, United States
Columbia University
New York, New York, United States
Global Research and Consulting
Olean, New York, United States
Monroe Community Hospital
Rochester, New York, United States
Staten Island University Hospital
Staten Island, New York, United States
Duke University Medical Center
Durham, North Carolina, United States
Wake Forest University School of Medicine
Winston-Salem, North Carolina, United States
University Hospital Health Systems-Laurelwood Hospital
Willoughby, Ohio, United States
VA Medical Center
Coatesville, Pennsylvania, United States
Mental Illness Research Education and Clinical Center
Philadelphia, Pennsylvania, United States
Medical University of South Carolina
North Charleston, South Carolina, United States
University of Texas Southwestern Medical Center
Dallas, Texas, United States
Southwestern Vermont Medical Center- The Memory Clinic
Bennington, Vermont, United States
Countries
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References
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Schneider LS, Tariot PN, Lyketsos CG, Dagerman KS, Davis KL, Davis S, Hsiao JK, Jeste DV, Katz IR, Olin JT, Pollock BG, Rabins PV, Rosenheck RA, Small GW, Lebowitz B, Lieberman JA. National Institute of Mental Health Clinical Antipsychotic Trials of Intervention Effectiveness (CATIE): Alzheimer disease trial methodology. Am J Geriatr Psychiatry. 2001 Fall;9(4):346-60.
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. doi: 10.1093/oxfordjournals.schbul.a006991.
Schneider LS, Tariot PN, Dagerman KS, Davis SM, Hsiao JK, Ismail MS, Lebowitz BD, Lyketsos CG, Ryan JM, Stroup TS, Sultzer DL, Weintraub D, Lieberman JA; CATIE-AD Study Group. Effectiveness of atypical antipsychotic drugs in patients with Alzheimer's disease. N Engl J Med. 2006 Oct 12;355(15):1525-38. doi: 10.1056/NEJMoa061240.
Reeves S, Bertrand J, Uchida H, Yoshida K, Otani Y, Ozer M, Liu KY, Bramon E, Bies R, Pollock BG, Howard R. Towards safer risperidone prescribing in Alzheimer's disease. Br J Psychiatry. 2021 May;218(5):268-275. doi: 10.1192/bjp.2020.225.
Nagata T, Shinagawa S, Yoshida K, Noda Y, Shigeta M, Mimura M, Nakajima S. Early Improvements of Individual Symptoms With Antipsychotics Predict Subsequent Treatment Response of Neuropsychiatric Symptoms in Alzheimer's Disease: A Re-Analysis of the CATIE-AD Study. J Clin Psychiatry. 2020 Feb 11;81(2):19m12961. doi: 10.4088/JCP.19m12961.
Ozawa C, Roberts R, Yoshida K, Suzuki T, Lebowitz B, Reeves S, Howard R, Abe T, Mimura M, Uchida H. Placebo Effects in the Treatment of Noncognitive Symptoms of Alzheimer's Disease: Analysis of the CATIE-AD Data. J Clin Psychiatry. 2017 Nov/Dec;78(9):e1204-e1210. doi: 10.4088/JCP.17m11461.
Yoshida K, Roberts R, Suzuki T, Lebowitz B, Reeves S, Howard R, Abe T, Mimura M, Uchida H. Lack of Early Improvement with Antipsychotics is a Marker for Subsequent Nonresponse in Behavioral and Psychological Symptoms of Dementia: Analysis of CATIE-AD Data. Am J Geriatr Psychiatry. 2017 Jul;25(7):708-716. doi: 10.1016/j.jagp.2017.01.016. Epub 2017 Jan 30.
Miller EA, Schneider LS, Rosenheck RA. Predictors of nursing home admission among Alzheimer's disease patients with psychosis and/or agitation. Int Psychogeriatr. 2011 Feb;23(1):44-53. doi: 10.1017/S1041610210000244. Epub 2010 Mar 10.
Zheng L, Mack WJ, Dagerman KS, Hsiao JK, Lebowitz BD, Lyketsos CG, Stroup TS, Sultzer DL, Tariot PN, Vigen C, Schneider LS. Metabolic changes associated with second-generation antipsychotic use in Alzheimer's disease patients: the CATIE-AD study. Am J Psychiatry. 2009 May;166(5):583-90. doi: 10.1176/appi.ajp.2008.08081218. Epub 2009 Apr 15.
Sultzer DL, Davis SM, Tariot PN, Dagerman KS, Lebowitz BD, Lyketsos CG, Rosenheck RA, Hsiao JK, Lieberman JA, Schneider LS; CATIE-AD Study Group. Clinical symptom responses to atypical antipsychotic medications in Alzheimer's disease: phase 1 outcomes from the CATIE-AD effectiveness trial. Am J Psychiatry. 2008 Jul;165(7):844-54. doi: 10.1176/appi.ajp.2008.07111779. Epub 2008 Jun 2.
Rosenheck RA, Leslie DL, Sindelar JL, Miller EA, Tariot PN, Dagerman KS, Davis SM, Lebowitz BD, Rabins P, Hsiao JK, Lieberman JA, Schneider LS; Clinical Antipsychotic Trial of Intervention Effectiveness-Alzheimer's Disease (CATIE-AD) investigators. Cost-benefit analysis of second-generation antipsychotics and placebo in a randomized trial of the treatment of psychosis and aggression in Alzheimer disease. Arch Gen Psychiatry. 2007 Nov;64(11):1259-68. doi: 10.1001/archpsyc.64.11.1259.
Related Links
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More information about Alzheimer's Disease
Other Identifiers
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N01 MH90001-AD
Identifier Type: -
Identifier Source: secondary_id
DSIR AT
Identifier Type: -
Identifier Source: secondary_id
N01 MH090001-05
Identifier Type: -
Identifier Source: org_study_id
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