The National Institute of Mental Health Clinical Antipsychotic Trials of Intervention Effectiveness (CATIE) project: schizophrenia trial design and protocol development - PubMed (original) (raw)
Clinical Trial
The National Institute of Mental Health Clinical Antipsychotic Trials of Intervention Effectiveness (CATIE) project: schizophrenia trial design and protocol development
T Scott Stroup et al. Schizophr Bull. 2003.
Abstract
The National Institute of Mental Health initiated the Clinical Antipsychotic Trials of Intervention Effectiveness (CATIE) program to evaluate the effectiveness of antipsychotic drugs in typical settings and populations so that the study results will be maximally useful in routine clinical situations. The CATIE schizophrenia trial blends features of efficacy studies and large, simple trials to create a pragmatic trial that will provide extensive information about antipsychotic drug effectiveness over at least 18 months. The protocol allows for subjects who receive a study drug that is not effective to receive subsequent treatments within the context of the study. Medication dosages are adjusted within a defined range according to clinical judgment. The primary outcome is all-cause treatment discontinuation because it represents an important clinical endpoint that reflects both clinician and patient judgments about efficacy and tolerability. Secondary outcomes include symptoms, side effects, neurocognitive functioning, and cost-effectiveness. Approximately 50 clinical sites across the United States are seeking to enroll a total of 1,500 persons with schizophrenia. Phase 1 is a double-blinded randomized clinical trial comparing treatment with the second generation antipsychotics olanzapine, quetiapine, risperidone, and ziprasidone to perphenazine, a midpotency first generation antipsychotic. If the initially assigned medication is not effective, subjects may choose one of the following phase 2 trials: (1) randomization to open-label clozapine or a double-blinded second generation drug that was available but not assigned in phase 1; or (2) double-blinded randomization to ziprasidone or another second generation drug that was available but not assigned in phase 1. If the phase 2 study drug is discontinued, subjects may enter phase 3, in which clinicians help subjects select an open-label treatment based on individuals' experiences in phases 1 and 2.
Similar articles
- What CATIE found: results from the schizophrenia trial.
Swartz MS, Stroup TS, McEvoy JP, Davis SM, Rosenheck RA, Keefe RS, Hsiao JK, Lieberman JA. Swartz MS, et al. Psychiatr Serv. 2008 May;59(5):500-6. doi: 10.1176/ps.2008.59.5.500. Psychiatr Serv. 2008. PMID: 18451005 Free PMC article. Clinical Trial. - Effectiveness of olanzapine, quetiapine, and risperidone in patients with chronic schizophrenia after discontinuing perphenazine: a CATIE study.
Stroup TS, Lieberman JA, McEvoy JP, Swartz MS, Davis SM, Capuano GA, Rosenheck RA, Keefe RS, Miller AL, Belz I, Hsiao JK; CATIE Investigators. Stroup TS, et al. Am J Psychiatry. 2007 Mar;164(3):415-27. doi: 10.1176/ajp.2007.164.3.415. Am J Psychiatry. 2007. PMID: 17329466 Clinical Trial. - The CATIE and CUtLASS studies in schizophrenia: results and implications for clinicians.
Naber D, Lambert M. Naber D, et al. CNS Drugs. 2009 Aug;23(8):649-59. doi: 10.2165/00023210-200923080-00002. CNS Drugs. 2009. PMID: 19594194 - An open, large, 6-month naturalistic study of outcome in schizophrenic outpatients, treated with olanzapine.
Krzystanek M, Krupka-Matuszczyk I. Krzystanek M, et al. Hum Psychopharmacol. 2011 Jan;26(1):81-5. doi: 10.1002/hup.1173. Epub 2011 Feb 9. Hum Psychopharmacol. 2011. PMID: 23055416 Review. - The CATIE schizophrenia trial: results, impact, controversy.
Manschreck TC, Boshes RA. Manschreck TC, et al. Harv Rev Psychiatry. 2007 Sep-Oct;15(5):245-58. doi: 10.1080/10673220701679838. Harv Rev Psychiatry. 2007. PMID: 17924259 Review.
Cited by
- Haloperidol (oral) versus olanzapine (oral) for people with schizophrenia and schizophrenia-spectrum disorders.
Ibragimov K, Keane GP, Carreño Glaría C, Cheng J, Llosa AE. Ibragimov K, et al. Cochrane Database Syst Rev. 2024 Jul 3;7(7):CD013425. doi: 10.1002/14651858.CD013425.pub2. Cochrane Database Syst Rev. 2024. PMID: 38958149 Review. - Sex Differences Between Female and Male Individuals in Antipsychotic Efficacy and Adverse Effects in the Treatment of Schizophrenia.
Galbally M, Wynter K, Siskind D, Correll CU, Northwood K, Every-Palmer S. Galbally M, et al. CNS Drugs. 2024 Jul;38(7):559-570. doi: 10.1007/s40263-024-01089-w. Epub 2024 May 7. CNS Drugs. 2024. PMID: 38713452 Free PMC article. Clinical Trial. - A call to action: informing research and practice in suicide prevention among individuals with psychosis.
Chalker SA, Sicotte R, Bornheimer LA, Parrish EM, Wastler H, Ehret B, DeVylder J, Depp CA. Chalker SA, et al. Front Psychiatry. 2024 Apr 22;15:1378600. doi: 10.3389/fpsyt.2024.1378600. eCollection 2024. Front Psychiatry. 2024. PMID: 38711871 Free PMC article. - Genome-wide association study implicates lipid pathway dysfunction in antipsychotic-induced weight gain: multi-ancestry validation.
Liao Y, Yu H, Zhang Y, Lu Z, Sun Y, Guo L, Guo J, Kang Z, Feng X, Sun Y, Wang G, Su Z, Lu T, Yang Y, Li W, Lv L, Yan H, Zhang D, Yue W. Liao Y, et al. Mol Psychiatry. 2024 Jun;29(6):1857-1868. doi: 10.1038/s41380-024-02447-2. Epub 2024 Feb 9. Mol Psychiatry. 2024. PMID: 38336841 - Ranking tailoring variables for constructing individualized treatment rules: an application to schizophrenia.
Wu J, Galanter N, Shortreed SM, Moodie EEM. Wu J, et al. J R Stat Soc Ser C Appl Stat. 2022 Mar;71(2):309-330. doi: 10.1111/rssc.12533. Epub 2022 Mar 20. J R Stat Soc Ser C Appl Stat. 2022. PMID: 38288004 Free PMC article.
Publication types
MeSH terms
Substances
LinkOut - more resources
Full Text Sources
Other Literature Sources
Medical