Meta-regression analysis of placebo response in antipsychotic trials, 1970-2010

American Journal of Psychiatry

Volumn 170, Issue 11, 2013, Pages 1335-1344

  Agid, Ofer ^a,b,c,d,e,f   Siu, Cynthia O ^a,b,c,d,e,f   Potkin, Steven G ^a,b,c,d,e,f   Kapur, Shitij ^a,b,c,d,e,f   Watsky, Eric ^a,b,c,d,e,f   Vanderburg, Douglas ^a,b,c,d,e,f   Zipursky, Robert B ^a,b,c,d,e,f   Remington, Gary ^a,b,c,d,e,f  

^a CENTRE FOR ADDICTION AND MENTAL HEALTH   (Canada)

^b Data Power Inc   (United States)

^c UNIVERSITY OF CALIFORNIA   (United States)

^d KING'S COLLEGE LONDON   (United Kingdom)

^e Pfizer Neuroscience   (United States)

^f MCMASTER UNIVERSITY   (Canada)

Author keywords

[No Author keywords available]

Indexed keywords

NEUROLEPTIC AGENT; PLACEBO;

ADULT; AGE DISTRIBUTION; ARTICLE; BRIEF PSYCHIATRIC RATING SCALE; CONTROLLED STUDY; DISEASE DURATION; DISEASE SEVERITY; DRUG EFFICACY; FEMALE; HUMAN; MAJOR CLINICAL STUDY; MALE; META ANALYSIS; OUTCOMES RESEARCH; PLACEBO EFFECT; POSITIVE AND NEGATIVE SYNDROME SCALE; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; REGRESSION ANALYSIS; SCHIZOPHRENIA; SYSTEMATIC REVIEW; TREATMENT DURATION;

EID: 84887478908     PISSN: 0002953X     EISSN: 15357228     Source Type: Journal    
DOI: 10.1176/appi.ajp.2013.12030315     Document Type: Article

References (38)

1. Zipursky RB, Darby P: Placebo-controlled studies in schizophrenia: ethical and scientific perspectives: an overview of conference proceedings. Schizophr Res 1999;35:189-200
2. Temple RJ: When are clinical trials of a given agent vs placebo no longer appropriate or feasible? Control Clin Trials 1997;18:613-620
3. Laughren TP: The scientific and ethical basis for placebocontrolled trials in depression and schizophrenia: an FDA perspective. Eur Psychiatry 2001;16:418-423
4. Kemp AS, Schooler NR, Kalali AH, Alphs L, Anand R, Awad G, Davidson M, Dubé S, Ereshefsky L, Gharabawi G, Leon AC, Lepine JP, Potkin SG, Vermeulen A: What is causing the reduced drug-placebo difference in recent schizophrenia clinical trials and what can be done about it? Schizophr Bull 2010;36:504-509
5. Chen YF, Wang SJ, Khin NA, Hung H M J, Laughren TP: Trial design issues and treatment effect modeling in multi-regional schizophrenia trials. Pharm Stat 2010;9:217-229
6. Kinon BJ, Potts AJ, Watson SB: Placebo response in clinical trials with schizophrenia patients. Curr Opin Psychiatry 2011;24:107-113
7. Leucht S, Arbter D, Engel RR, Kissling W, Davis JM: How effective are second-generation antipsychotic drugs? A meta-analysis of placebo-controlled trials. Mol Psychiatry 2009;14:429-447
8. Laporte JR, Figueras A: Placebo effects in psychiatry. Lancet 1994;344:1206-1209
9. Cressey D: Traditional drug-discovery model ripe for reform. Nature 2011;471:17-18
10. Nutt D, Goodwin G: ECNP Summit on the future of CNS drug research in Europe 2011: report prepared for ECNP by David Nutt and Guy Goodwin. Eur Neuropsychopharmacol 2011;21:495-499
11. Leucht S, Corves C, Arbter D, Engel RR, Li C, Davis JM: Secondgeneration versus first-generation antipsychotic drugs for schizophrenia: a meta-analysis. Lancet 2009;373:31-41
12. PillaReddy V, Kozielska M, Johnson M, Vermeulen A, De Greef R, Liu J, Groothuis G M M, Danhof M, Proost JH: Structural models describing placebo treatment effects in schizophrenia and other neuropsychiatric disorders. Clin Pharmacokinet 2011;50:429-450
13. Welge JA, Keck PE Jr: Moderators of placebo response to antipsychotic treatment in patients with schizophrenia: a metaregression. Psychopharmacology (Berl) 2003;166:1-10
14. Mallinckrodt CH, Zhang L, Prucka WR, Millen BA: Signal detection and placebo response in schizophrenia: parallels with depression. Psychopharmacol Bull 2010;43:53-72
15. Leucht S, Wahlbeck K, Hamann J, Kissling W: New generation antipsychotics versus low-potency conventional antipsychotics: a systematic review and meta-analysis. Lancet 2003;361:1581-1589
16. McMahon RP, Kelly DL, Boggs DL, Li L, Hu Q, Davis JM, Carpenter WT Jr: Feasibility of reducing the duration of placebo-controlled trials in schizophrenia research. Schizophr Bull 2008;34:292-301
17. Kane JM, Leucht S: Unanswered questions in schizophrenia clinical trials. Schizophr Bull 2008;34:302-309
18. Dunlop BW, Thase ME, Wun CC, Fayyad R, Guico-Pabia CJ, Musgnung J, Ninan PT: A meta-analysis of factors impacting detection of antidepressant efficacy in clinical trials: the importance of academic sites. Neuropsychopharmacology 2012;37:2830-2836
19. Leucht S, Heres S, Hamann J, Kane JM: Methodological issues in current antipsychotic drug trials. Schizophr Bull 2008;34:275-285
20. Potkin S, Agid O, Siu C, Watsky E, Vanderburg D, Remington G: Placebo response trajectories in short-term and long-term antipsychotic trials in schizophrenia. Schizophr Res 2011;132:108-113
21. Merlo-Pich E, Alexander RC, Fava M, Gomeni R: A new population-enrichment strategy to improve efficiency of placebo-controlled clinical trials of antidepressant drugs. Clin Pharmacol Ther 2010;88:634-642
22. Kocsis JH, Gerber AJ, Milrod B, Roose SP, Barber J, Thase ME, Perkins P, Leon AC: A new scale for assessing the quality of randomized clinical trials of psychotherapy. Compr Psychiatry 2010;51:319-324
23. Becker BJ: Synthesizing standardized mean-change measures. Br J Math Stat Psychol 1988;41:257-278
24. Dunlap WP, Cortina JM, Vaslow JB, Burke MJ: Meta-analysis of experiments with matched groups or repeated measures designs. Psychol Methods 1996;1:170-177
25. Morris SB: Distribution of the standardized mean change effect size for meta-analysis on repeated measures. Br J Math Stat Psychol 2000;53:17-29
26. Glass GV: Integrating findings: the meta-analysis of research, in Review of Research in Education, vol 5. Edited by Schulman LS. Itasca, Ill, FE Peacock, 1977
27. Cohen J: Statistical Power Analysis for the Behavioral Sciences, 2nd ed. Hillsdale, NJ, Lawrence Erlbaum Associates, 1988
28. Der Simonian R, Laird N: Meta-analysis in clinical trials. Control Clin Trials 1986;7:177-188
29. Higgins J P T, Green S: Cochrane Handbook for Systematic Reviews of Interventions 4.2.6, in The Cochrane Library. Chichester, UK, Wiley & Sons, 2006
30. Cleveland WS, Devlin SJ: Locally-weighted regression: an approach to regression analysis by local fitting. J Am Stat Assoc 1988;83:596-610
31. West S, King V, Carey TS, Lohr KN, McKoy N, Sutton SF, Lux L: Systems to Rate the Strength of Scientific Evidence (Evidence Report/Technology Assessment No 47, AHRQ Publication No 02-E016). Rockville, Md, Agency for Healthcare Research and Quality, April 2002
32. Allison DB, Loebel AD, Lombardo I, Romano SJ, Siu CO: Understanding the relationship between baseline BMI and subsequent weight change in antipsychotic trials: effect modification or regression to the mean? Psychiatry Res 2009;170:172-176
33. Yudkin PL, Stratton IM: How to deal with regression to the mean in intervention studies. Lancet 1996;347:241-243
34. Altman DG, Andersen PK: Bootstrap investigation of the stability of a Cox regression model. Stat Med 1989;8:771-783
35. Derksen S, Keselman HJ: Backward, forward, and stepwise automated subset selection algorithms: frequency of obtaining authentic and noise variables. Br J Math Stat Psychol 1992;45:265-282
36. Patel NC, Crismon ML, Miller AL, Johnsrud MT: Drug adherence: effects of decreased visit frequency on adherence to clozapine therapy. Pharmacotherapy 2005;25:1242-1247
37. Taiminen T, Syvalahti E, Saarijarvi S, Niemi H, Lehto H, Ahola V, Salokangas R K R: Prediction of positive placebo response among chronic schizophrenic outpatients. J Nerv Ment Dis 1996;184:109-113
38. Fournier JC, De Rubeis RJ, Hollon SD, Dimidjian S, Amsterdam JD, Shelton RC, Fawcett J: Antidepressant drug effects and depression severity: a patient-level meta-analysis. JAMA 2010;303:47-53