The impact of restrictive entry criterion during the placebo lead-in period.
In the study of depression, most randomized clinical trials have design features that attempt to sample from a stable patient population. One commonly used design feature is to require patients to maintain some minimum baseline symptom severity score during a placebo lead-in period. One intent of this design feature is to evaluate the behavior of patients prior to administration of active medication. If, during the lead-in period, patients do not maintain minimum symptom severity, the patients are excluded from the remainder of the study, the theory being that the excluded patients are not part of a stable patient population and hence are not likely to demonstrate efficacy of a truly effective treatment. This presentation investigates the effectiveness of a restrictive entry criterion and proposes an alternative explanation for what is usually defined as placebo response.
Landin
R
R
Lilly Research Laboratories, Lilly Corporate Center, Indianapolis, Indiana 46285, USA. richard.landin@wl.com
DeBrota
D J
DJ
DeVries
T A
TA
Potter
W Z
WZ
Demitrack
M A
MA
D000928:Antidepressive Agents / Q000627:therapeutic use; D001699:Biometry; D002986:Clinical Trials as Topic / Q000379:methods* / Q000706:statistics & numerical data; D003863:Depression / Q000188:drug therapy / Q000523:psychology; D006801:Humans; D016014:Linear Models; D010919:Placebos; D016032:Randomized Controlled Trials as Topic / Q000379:methods / Q000706:statistics & numerical data; D016037:Single-Blind Method
D000928:Antidepressive Agents; D010919:Placebos