TY - JOUR
T1 - Results of phase 3 of the CATIE schizophrenia trial
AU - Stroup, T. Scott
AU - Lieberman, Jeffrey A.
AU - McEvoy, Joseph Patrick
AU - Davis, Sonia M.
AU - Swartz, Marvin S.
AU - Keefe, Richard S.E.
AU - Miller, Alexander L.
AU - Rosenheck, Robert A.
AU - Hsiao, John K.
N1 - Funding Information:
Funding for this study was provided by NIMH contract N01 MH 90001; the NIMH was involved in all phases of the study. Study drugs were donated by the manufacturers; the companies were not involved in designing or conducting the study, analyzing or interpreting the data, or deciding to submit the paper for publication.
Funding Information:
Dr. Stroup reports having received consulting fees from Janssen Pharmaceutica Products, Eli Lilly and Co., Lundbeck, and Solvay. Dr. Lieberman reports having received research funding from AstraZeneca Pharmaceuticals LP, Bristol-Myers Squibb, GlaxoSmithKline, Janssen Pharmaceutica Products, and Pfizer Inc.; and consulting and educational fees from AstraZeneca Pharmaceuticals LP, Bristol-Myers Squibb, Eli Lilly and Co., Forest Pharmaceutical Company, GlaxoSmithKline, Janssen Pharmaceutica Products, Novartis, Pfizer Inc., and Solvay. Dr. McEvoy reports having received research funding from AstraZeneca, Forest Research Institute, Eli Lilly and Co., Janssen Pharmaeutica, and Pfizer Inc.; consulting or advisory board fees from Pfizer Inc. and Bristol-Myers Squibb; and lecture fees from Janssen Pharmaceutica, and Bristol-Myers Squibb. Dr. Sonia M. Davis is an employee of Quintiles Inc.; she reports no additional funding. Dr. Swartz reports having received research funding from Eli Lilly and Co., and consulting and educational fees from AstraZeneca Pharmaceuticals LP, Bristol-Myers Squibb, Eli Lilly and Co., and Pfizer Inc. Dr. Keefe reports having received research funding from AstraZeneca, Eli Lilly and Co., and Janssen Pharmaeutica; consulting fees or advisory board payments from Forest Labs, Eli Lilly and Co., Janssen Pharmaceutica, Pfizer Inc., and Bristol-Myers Squibb; and lecture fees from Eli Lilly and Co. and Janssen Pharmaceutica. Dr. Miller reports having received research funding and consulting and speaking fees from Alexza, AstraZeneca, Bristol-Myers Squibb, Eli Lilly, Forest, GlaxoSmithKline, Janssen, Pfizer, and Solvay. Dr. Rosenheck reports having received research funding from AstraZeneca Pharmaceuticals LP, Bristol-Myers Squibb, and Eli Lilly and Co.; and consulting fees from Bristol-Myers Squibb, Eli Lilly and Co., and Janssen Pharmaceutica Products. Dr. Hsiao and Dr. Davis report no competing interests.
Funding Information:
This article was based on results from the Clinical Antipsychotic Trials of Intervention Effectiveness project, supported by the National Institute of Mental Health (NO1 MH90001). The aim of this project is to examine the comparative effectiveness of antipsychotic drugs in conditions for which their use is clinically indicated, including schizophrenia and Alzheimer's disease. The project was carried out by principal investigators from the University of North Carolina, Duke University, the University of Southern California, the University of Rochester, and Yale University in association with Quintiles, Inc.; the program staff of the Division of Interventions and Services Research of the NIMH; and investigators from 56 sites in the United States (CATIE Study Investigators Group). AstraZeneca Pharmaceuticals LP, Bristol-Myers Squibb Company, Forest Pharmaceuticals, Inc., Janssen Pharmaceutica Products, L.P., Eli Lilly and Company, Otsuka Pharmaceutical Co., Ltd., Pfizer Inc., and Zenith Goldline Pharmaceuticals, Inc., provided medications for the studies.
PY - 2009/1
Y1 - 2009/1
N2 - Objective: The Clinical Antipsychotic Trials of Intervention Effectiveness (CATIE) study examined the comparative effectiveness of antipsychotic treatments for individuals with chronic schizophrenia. Patients who had discontinued antipsychotic treatment in phases 1 and 2 were eligible for phase 3, in which they selected one of nine antipsychotic regimens with the help of their study doctor. We describe the characteristics of the patients who selected each treatment option and their outcomes. Method: Two hundred and seventy patients entered phase 3. The open-label treatment options were monotherapy with oral aripiprazole, clozapine, olanzapine, perphenazine, quetiapine, risperidone, ziprasidone, long-acting injectable fluphenazine decanoate, or a combination of any two of these treatments. Results: Few patients selected fluphenazine decanoate (n = 9) or perphenazine (n = 4). Similar numbers selected each of the other options (range 33-41). Of the seven common choices, those who selected clozapine and combination antipsychotic treatment were the most symptomatic, and those who selected aripiprazole and ziprasidone had the highest body mass index. Symptoms improved for all groups, although the improvements were modest for the groups starting with relatively mild levels of symptoms. Side effect profiles of the medications varied considerably but medication discontinuations due to intolerability were rare (7% overall). Conclusions: Patients and their doctors made treatment selections based on clinical factors, including severity of symptoms, response to prior treatments, and physical health status. Fluphenazine decanoate was rarely used among those with evidence of treatment non-adherence and clozapine was underutilized for those with poor previous response. Combination antipsychotic treatment warrants further study.
AB - Objective: The Clinical Antipsychotic Trials of Intervention Effectiveness (CATIE) study examined the comparative effectiveness of antipsychotic treatments for individuals with chronic schizophrenia. Patients who had discontinued antipsychotic treatment in phases 1 and 2 were eligible for phase 3, in which they selected one of nine antipsychotic regimens with the help of their study doctor. We describe the characteristics of the patients who selected each treatment option and their outcomes. Method: Two hundred and seventy patients entered phase 3. The open-label treatment options were monotherapy with oral aripiprazole, clozapine, olanzapine, perphenazine, quetiapine, risperidone, ziprasidone, long-acting injectable fluphenazine decanoate, or a combination of any two of these treatments. Results: Few patients selected fluphenazine decanoate (n = 9) or perphenazine (n = 4). Similar numbers selected each of the other options (range 33-41). Of the seven common choices, those who selected clozapine and combination antipsychotic treatment were the most symptomatic, and those who selected aripiprazole and ziprasidone had the highest body mass index. Symptoms improved for all groups, although the improvements were modest for the groups starting with relatively mild levels of symptoms. Side effect profiles of the medications varied considerably but medication discontinuations due to intolerability were rare (7% overall). Conclusions: Patients and their doctors made treatment selections based on clinical factors, including severity of symptoms, response to prior treatments, and physical health status. Fluphenazine decanoate was rarely used among those with evidence of treatment non-adherence and clozapine was underutilized for those with poor previous response. Combination antipsychotic treatment warrants further study.
KW - Antipsychotic
KW - Clinical trial
KW - Effectiveness
KW - Schizophrenia
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U2 - 10.1016/j.schres.2008.10.011
DO - 10.1016/j.schres.2008.10.011
M3 - Article
C2 - 19027269
AN - SCOPUS:58149131304
VL - 107
SP - 1
EP - 12
JO - Schizophrenia Research
JF - Schizophrenia Research
SN - 0920-9964
IS - 1
ER -