TY - JOUR
T1 - Predicting potential placebo effect in drug treated subjects
AU - Petkova, Eva
AU - Tarpey, Thaddeus
AU - Govindarajulu, Usha
N1 - Funding Information:
KEYWORDS: longitudinal outcome, linear mixed effects models, BLUP, non-specific treatment effect, specific drug effect, allometric extension, principal components Author Notes: The authors are indebted to Drs. P. McGrath, J. Stewart and the late Dr. Fred Quitkin from the Depression Evaluation Services (DES) unit at the New York State Psychiatric Institute (NYSPI) and Columbia University, Department of Psychiatry for insightful discussions and guidance in understanding the medical question. The authors are grateful to the Eli Lilly Company for providing the data used in this manuscript. We thank a referee and an Associate Editor of the journal for thoughtful comments that helped improve the manuscript. This work was supported by NIMH grant R01 MH68401.
PY - 2009
Y1 - 2009
N2 - Non-specific responses to treatment (commonly known as placebo response) are pervasive when treating mental illness. Subjects treated with an active drug may respond in part due to non-specific aspects of the treatment, i.e, those not related to the chemical effect of the drug. To determine the extent a subject responds due to the chemical effect of a drug, one must disentangle the specific drug effect from the non-specific placebo effect. This paper presents a unique statistical model that allows for the separate prediction of a specific effect and non-specific effects in drug treated subjects. Data from a clinical trial comparing fluoxetine to a placebo for treating depression is used to illustrate this methodology.
AB - Non-specific responses to treatment (commonly known as placebo response) are pervasive when treating mental illness. Subjects treated with an active drug may respond in part due to non-specific aspects of the treatment, i.e, those not related to the chemical effect of the drug. To determine the extent a subject responds due to the chemical effect of a drug, one must disentangle the specific drug effect from the non-specific placebo effect. This paper presents a unique statistical model that allows for the separate prediction of a specific effect and non-specific effects in drug treated subjects. Data from a clinical trial comparing fluoxetine to a placebo for treating depression is used to illustrate this methodology.
KW - Allometric extension
KW - BLUP
KW - Linear mixed effects models
KW - Longitudinal outcome
KW - Non-specific treatment effect
KW - Principal components
KW - Specific drug effect
UR - https://www.scopus.com/pages/publications/68549097968
U2 - 10.2202/1557-4679.1152
DO - 10.2202/1557-4679.1152
M3 - Article
C2 - 21556319
AN - SCOPUS:68549097968
SN - 1557-4679
VL - 5
JO - International Journal of Biostatistics
JF - International Journal of Biostatistics
IS - 1
M1 - 23
ER -