Placebo non-response measure in sequential parallel comparison design studies

Statistics in Medicine

Volumn 34, Issue 15, 2015, Pages 2281-2293

  Rybin, Denis ^a   Doros, Gheorghe ^a,b   Pencina, Michael J ^c   Fava, Maurizio ^d  

^a BOSTON UNIVERSITY   (United States)

^b HARVARD CLINICAL RESEARCH INSTITUTE   (United States)

^c DUKE CLINICAL RESEARCH INSTITUTE   (United States)

^d MASSACHUSETTS GENERAL HOSPITAL   (United States)

Author keywords

Placebo effect; Repeated measures; SPCD

Indexed keywords

ANTIDEPRESSANT AGENT; ARIPIPRAZOLE; PLACEBO;

ARTICLE; CONTROLLED STUDY; HUMAN; LOW DRUG DOSE; MAJOR DEPRESSION; MONTE CARLO METHOD; MONTGOMERY ASBERG DEPRESSION RATING SCALE; NONRESPONSE BIAS; NORMAL DISTRIBUTION; NULL HYPOTHESIS; PLACEBO EFFECT; PRINCIPAL COMPONENT ANALYSIS; PROBABILITY; PROPENSITY SCORE; SEQUENTIAL PARALLEL COMPARISON DESIGN; SIMULATION; STATISTICAL ANALYSIS; STUDY DESIGN; METHODOLOGY; RANDOMIZED CONTROLLED TRIAL (TOPIC); STATISTICAL MODEL;

HUMANS; MODELS, STATISTICAL; PLACEBOS; RANDOMIZED CONTROLLED TRIALS AS TOPIC; RESEARCH DESIGN;

EID: 84930383082     PISSN: 02776715     EISSN: 10970258     Source Type: Journal    
DOI: 10.1002/sim.6494     Document Type: Article

References (16)

1. Fava M, Evins AE, Dorer DJ, A SD. The problem of the placebo response in clinical trials for psychiatric disorders: culprits, possible remedies, and a novel study design approach. Psychotherapy and Psychosomatics 2003; 72:115-127.
2. Ivanova A, Qaqish B, Schoenfeld DA. Optimality, sample size, and power calculations for the sequential parallel comparison design. Statistics in Medicine 2011; 30(23):2793-2803.
3. Enck P, Klosterhalfen S, Weimer K, Horing B, Zipfel S. The placebo response in clinical trials: more questions than answers. Philosophical Transactions of Royal Society B 2011; 366:1889-1895.
4. Fava M, Schoenfeld D. System and method for reducing the placebo effect in controlled clinical trials, 2010. http://www.patentlens.net/patentlens/patent/US_7840419/en/ [Accessed on 21 February 2014].
5. Fava M, Schoenfeld D. System and method for reducing the placebo effect in controlled clinical trials, 2010. http://www.patentlens.net/patentlens/patent/US_7647235/en/ [Accessed on 21 February 2014].
6. Fava M, Schoenfeld D. System and method for reducing the placebo effect in controlled clinical trials, 2011. http://www.patentlens.net/patentlens/patent/US_7983936/en/ [Accessed on 21 February 2014].
7. Fava M, Schoenfeld D. System and method for reducing the placebo effect in controlled clinical trials, 2012. http://www.patentlens.net/patentlens/patent/US_8145504/en/ [Accessed on 21 February 2014].
8. Fava M, Schoenfeld D. System and method for reducing the placebo effect in controlled clinical trials, 2012. http://www.patentlens.net/patentlens/patent/US_8145505/en/ [Accessed on 21 February 2014].
9. Fedorov VV, Liu T. Enrichment Design. Wiley Encyclopedia of Clinical Trials, 2007, 1-8.
10. Huang X, Tamura RN. Comparison of test statistics for the sequential parallel design. Statistics in Biopharmaceutical Research 2010; 2:42-50.
11. Tamura RN, Huang X, Boos DD. Estimation of treatment effectfor the sequential parallel design. Statistics in Medicine 2011; 30:3496-3506.
12. Tamura RN, Huang X. An examination of the efficiency of the sequential parallel design in psychiatric clinical trials. Clinical Trials 2007; 4:309-317.
13. Chen YF, Yang Y, Hung HJ, Wang SJ. Evaluation of performance of some enrichment designs dealing with high placebo responce in psychiatric clinical trials. Contemporary Clinical Trials 2011; 32:592-604.
14. Doros G, Pencina M, Rybin D, Meisner A, Fava M. A repeated measures model for analysis of continuous outcomes in sequential parallel comparison design studies. Statistics in Medicine 2013; 32(16): 2767-2789.
15. Fava M, Mischoulon D, Iosifescu D, Witte J, Pencina M, Flynn M, Harper L, Levy M, K Rickels, Pollack M. A double-blind, placebo-controlled study of aripiprazole adjunctive toantidepressant therapy among depressed outpatients with inadequate response to prior antidepressant therapy (adapt-a study). Psychotherapy and Psychosomatics 2012; 81:87-97.
16. Fava M, Mischoulon D, Iosifescu D, Witte J, Pencina M, Flynn M, Harper L, Levy M, Rickels K, Pollack M. Adouble-blind, placebo-controlled study of aripiprazole adjunctive to antidepressant therapy (ADT) among depressed outpatients with inadequate response to prior ADT (ADAPT-A Study). The 48th Annual Meeting of the American College of Neuropsychopharmacology, Hollywood, Florida, 2009.