Clinical trials design lessons from the CATIE study

American Journal of Psychiatry

Volumn 166, Issue 11, 2009, Pages 1222-1228

  Kraemer, Helena Chmura ^a   Glick, Ira D ^a   Klein, Donald F ^a  

^a NONE

Author keywords

[No Author keywords available]

Indexed keywords

ATYPICAL ANTIPSYCHOTIC AGENT; HALOPERIDOL; NEUROLEPTIC AGENT; OLANZAPINE; PERPHENAZINE; QUETIAPINE; RISPERIDONE; ZIPRASIDONE;

CLINICAL DECISION MAKING; CLINICAL EFFECTIVENESS; CLINICAL PRACTICE; CLINICAL RESEARCH; CLINICAL TRIAL; COHORT ANALYSIS; COST; DISEASE SEVERITY; DRUG EFFICACY; DRUG SAFETY; DRUG WITHDRAWAL; EXTRAPYRAMIDAL SYMPTOM; FOOD AND DRUG ADMINISTRATION; HUMAN; MENTAL HEALTH; OUTCOME ASSESSMENT; PRIORITY JOURNAL; REVIEW; SCHIZOPHRENIA; STRATIFICATION; TARDIVE DYSKINESIA; TREATMENT FAILURE; TREATMENT OUTCOME; TREATMENT RESPONSE;

ADOLESCENT; ADULT; AGED; ANTIPSYCHOTIC AGENTS; BENZODIAZEPINES; DOUBLE-BLIND METHOD; DYSKINESIA, DRUG-INDUCED; FEMALE; HUMANS; MALE; MIDDLE AGED; MULTICENTER STUDIES AS TOPIC; OUTCOME ASSESSMENT (HEALTH CARE); PERPHENAZINE; RANDOMIZED CONTROLLED TRIALS AS TOPIC; RESEARCH DESIGN; SCHIZOPHRENIA; UNITED STATES;

EID: 70449337423     PISSN: 0002953X     EISSN: 15357228     Source Type: Journal    
DOI: 10.1176/appi.ajp.2009.08121809     Document Type: Review

References (26)

1. Moore TJ: Deadly Medicine: Why Tens of Thousands of Heart Patients Died in America's Worst Drug Disaster. New York, Simon & Schuster, 1995
2. Lieberman JA, Stroup TS, McEvoy JP, Swartz MS, Rosenheck RA, Perkins DO, Keefe RS, Davis SM, Davis CE, Lebowitz BD, Severe J, Hsiao JK: Effectiveness of antipsychotic drugs in patients with chronic schizophrenia. N Engl J Med 2005; 353:1209-1223 (Pubitemid 41345943)
3. Cohen J: Statistical Power Analysis for the Behavioral Sciences. Hillsdale, NJ, Lawrence Erlbaum Associates, 1988
4. Kraemer HC, Thiemann S: How Many Subjects? Statistical Power Analysis in Research. Newbury Park, Calif, Sage Publications, 1987
5. MTA Cooperative Group: A 14-month clinical trial of treatment strategies for attention-deficit/hyperactivity disorder. Arch Gen Psychiatry 1999; 56:1073-1086
6. Jones LV, Tukey JW: A sensible formulation of the significance test. Psychol Methods 2000; 5:411-414
7. Meehl PE: Theoretical risks and tabular asterisks: Sir Karl, Sir Ronald, and the slow progress of soft psychology. J Consult Clin Psychol 1978; 46:806-834
8. Rosenheck RA: reply to Fusar-Poli RR: Clinical experiences and clinical trials (letter). CNS Spectrum 2008; 13:462-463
9. Citrome L, Jaffee A, Martello D, Allingham B, Levine J: Did CATIE influence antipsychotic use? Psychiatr Serv 2008; 59:476
10. Altman DG, Schulz KF, Hoher D, Egger M, Davidoff F, Elbourne D, Gøtzsche PC, Lang T, CONSORT Group: The revised CONSORT statement for reporting randomized trials: explanation and elaboration. Ann Intern Med 2001; 134:663-694 (Pubitemid 32322245)
11. Kraemer HC, Kupfer DJ: Size of treatment effects and their importance to clinical research and practice. Biol Psychiatry 2006; 59:990-996 (Pubitemid 43849650)
12. Borenstein M: The shift from significance testing to effect size estimation, in Comprehensive Clinical Psychology, vol 3: Research & Methods. Edited by Bellack AS, Hersen M. Burlington, Mass, Pergamon, 1998, pp 319-349
13. Borenstein M: Hypothesis testing and effect size estimation in clinical trials. Ann Allergy Asthma Immunol 1997; 78:5-16 (Pubitemid 27058314)
14. Wilkinson L, Task Force on Statistical Inference: Statistical methods in psychology journals: guidelines and explanations. Am Psychol 1999; 54:594-604
15. Humphreys K, Weisner C: Use of exclusion criteria in selecting research subjects and its effect on the generalizability of alcohol treatment outcome studies. Am J Psychiatry 2000; 157:588-594 (Pubitemid 30191198)
16. Wells KB: Treatment research at the crossroads: the scientific interface of clinical trials and effectiveness research. Am J Psychiatry 1999; 156:5-10 (Pubitemid 29034873)
17. Kraemer HC: Pitfalls of multisite randomized clinical trials of efficacy and effectiveness. Schizophr Bull 2000; 26:535-543
18. Kraemer HC, Robinson TN: Are certain multicenter randomized clinical trials structures misleading clinical and policy decisions? Control Clin Trials 2005; 26:518-529
19. Enhancing the outcomes of low-birth-weight, premature infants: a multisite, randomized trial: the Infant Health and Development Program. JAMA 1990; 263:3035-3042
20. Kraemer HC, Frank E, Kupfer DJ: Moderators of treatment outcomes: clinical, research, and policy importance. JAMA 2006; 296:1286-1289 (Pubitemid 44394901)
21. Kraemer HC, Wilson GT, Fairburn CG, Agras WS: Mediators and moderators of treatment effects in randomized clinical trials. Arch Gen Psychiatry 2002; 59:877-883
22. Essock SM, Covell NH, Davids SM, Stroup TS, Rosenheck RA, Lieberman JA: Effectiveness of switching antipsychotic medications. Am J Psychiatry 2006; 163:2090-2095
23. Kraemer HC, Blasey C: Centring in regression analysis: a strategy to prevent errors in statistical inference. Int J Methods Psychiatr Res 2004; 13:141-151
24. Chan AW, Hrobjartsson A, Haahr MT, Gotzsche PC, Altman DG: Empirical evidence for selective reporting of outcome in randomized trials. JAMA 2004; 291:2457-2465
25. DeAngelis CD, Drazen JM, Frizelle FA, Haug C, Hoey J, Horton R, Kotzin S, Laine C, Marusic A, Overbeke AJ, Schroeder TV, Sox HC, Van Der Weyden MB, International Committee of Medical Journal Editors: Is this clinical trial fully registered? JAMA 2005; 293:2927-2929
26. Weiden PJ: Discontinuing and switching antipsychotic medications: understanding the CATIE schizophrenia trial. J Clin Psychiatry 2007; 68(suppl 1):12-19 (Pubitemid 46256966)