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| Clinical Antipsychotic Trials of Intervention Effectiveness | |
|---|---|
| Name | Clinical Antipsychotic Trials of Intervention Effectiveness |
| Acronym | CATIE |
| Started | 2001 |
| Completed | 2005 |
| Sponsor | National Institute of Mental Health |
| Location | United States |
Clinical Antipsychotic Trials of Intervention Effectiveness The Clinical Antipsychotic Trials of Intervention Effectiveness was a large pragmatic randomized trial initiated by the National Institute of Mental Health and conducted at multiple sites including academic centers such as Columbia University, Johns Hopkins University, and Massachusetts General Hospital with coordination by organizations like the Duke University and contractors such as Westat. The trial compared several antipsychotic medications in outpatients diagnosed with schizophrenia across clinical networks associated with institutions like Yale University, University of California, Los Angeles, and University of Pennsylvania to inform treatment policy in the United States alongside stakeholders including the Food and Drug Administration, National Institutes of Health, and advocacy groups such as the American Psychiatric Association.
The trial was designed against a backdrop of regulatory decisions by the Food and Drug Administration and clinical practice guidance from the American Psychiatric Association after the introduction of second-generation antipsychotics marketed by companies such as Janssen Pharmaceuticals, Eli Lilly and Company, and AstraZeneca and public debates involving figures like Ronald Reagan era policy changes and reports from the Institute of Medicine. Concerns raised in editorials in journals tied to institutions like Harvard Medical School, Stanford University School of Medicine, and University of Chicago prompted comparative effectiveness research supported by the National Institute of Mental Health and stakeholders including the Robert Wood Johnson Foundation, the Kaiser Family Foundation, and advocacy groups such as the National Alliance on Mental Illness.
CATIE used a pragmatic randomized design modeled on multisite trials previously conducted by networks such as the Clinical Antipsychotic Trials (CAT), and employed methodology influenced by randomized trials at centers like Oxford University and Cambridge University. The protocol incorporated random allocation procedures overseen by data centers with experience from Duke University, Columbia University, and University of North Carolina at Chapel Hill and used assessment instruments validated in studies at Massachusetts General Hospital, McLean Hospital, and Sheppard Pratt Health System. Trial oversight included institutional review boards at Johns Hopkins University, Yale University, and University of California, San Diego with data monitoring influenced by panels including alumni of Harvard University, Princeton University, and Brown University.
Participants were outpatients recruited from clinical sites affiliated with networks such as Columbia University, University of Pennsylvania, and New York University medical centers, with inclusion criteria operationalized similarly to cohorts described at Mayo Clinic, Cleveland Clinic, and Johns Hopkins University. Randomized interventions compared first-generation agents historically used at institutions like Massachusetts General Hospital with second-generation antipsychotics marketed by corporations including Roche, Pfizer, and GlaxoSmithKline and included medications that had regulatory review by the Food and Drug Administration and formulary evaluations at systems like Veterans Health Administration. Trial conduct drew on recruitment strategies used by networks such as National Institutes of Health clinical centers, community clinics connected to University of California, San Francisco, and specialty programs at Columbia University.
Primary effectiveness outcomes adapted scales developed and validated at centers such as Yale University, Johns Hopkins University, and Stanford University while health economics endpoints paralleled methods from studies at Harvard School of Public Health and University of Pennsylvania. Statistical analysis plans were modeled on techniques used in multisite trials at Duke University, University of Michigan, and University of California, Los Angeles with intent-to-treat frameworks informed by guidance from the National Institutes of Health and data-safety monitoring approaches analogous to those at National Heart, Lung, and Blood Institute studies.
The trial reported that overall effectiveness and discontinuation rates were similar across several second-generation agents compared with a first-generation antipsychotic, findings that provoked commentary in outlets associated with Harvard Medical School, Columbia University, and Johns Hopkins University. Subgroup analyses examined metabolic outcomes and functional endpoints with comparisons to epidemiologic reports from Centers for Disease Control and Prevention, economic analyses akin to work at RAND Corporation, and health services research traditions at Kaiser Permanente. The findings influenced policy discussions within the Food and Drug Administration, the Centers for Medicare & Medicaid Services, and professional societies such as the American Psychiatric Association.
Safety signals included metabolic adverse effects documented previously in pharmacovigilance reports from the Food and Drug Administration and cohort studies at institutions like Massachusetts General Hospital, Mayo Clinic, and Cleveland Clinic, and extrapyramidal symptoms compared with historical series described at Johns Hopkins University and University of California, San Diego. Reports of weight gain, diabetes risk, and lipid changes echoed findings from trials sponsored by companies such as Eli Lilly and Company and AstraZeneca and were debated in editorials associated with Harvard School of Public Health and the New England Journal of Medicine editorial board.
Interpretation emphasized generalizability to routine outpatient settings similar to clinics affiliated with Yale University, University of Pennsylvania, and Columbia University, while limitations included attrition patterns and crossover considerations noted in methodological critiques from scholars at Stanford University, Oxford University, and Cambridge University. Implications affected prescribing guidance disseminated by the American Psychiatric Association, formulary decision-making at the Veterans Health Administration, and reimbursement policies debated at the Centers for Medicare & Medicaid Services, and informed subsequent comparative effectiveness efforts funded by the Patient-Centered Outcomes Research Institute and National Institutes of Health.
Category:Clinical trials