Placebo response is a potentially devastating component of CNS trials, particularly those with subjective patient-reported outcomes and high levels of interaction with clinical staff. In pain, depression, and other psychiatric studies using subjective primary endpoints, high placebo rates contribute substantially to the late-stage failure of promising treatments.
VeraSci is now offering a scientifically-backed instrument, the Placebo Control Reminder Script (PCRS), through the Pathway eCOA system. The PCRS, developed by the Hassman Research Institute, is a brief script read to participants immediately before administering study assessments. It educates and reminds them about placebo response factors and has been shown to decrease placebo response.
Data from a study of the PCRS were presented at the 2020 Annual Meeting of the American Society of Clinical Psychopharmacology (ASCP). The study examined the PCRS in subjects with major depressive disorder or with a psychotic disorder who had at least moderate depression. Subjects were randomized to either the intervention group or the control group. The intervention group was read the PCRS before administering the baseline and each subsequent assessment. The PCRS was not read to the control group. Subjects were told they had a 50% chance of receiving either the placebo or an active drug, but all subjects received a placebo. Subjects in the intervention group reported significantly smaller reductions in depression than the control group (i.e., a smaller placebo response). The intervention group also reported fewer adverse events. These findings indicate the PCRS is a useful tool to mitigate elevated placebo response rates that are often seen in failed late phase trials.
The PCRS is easy to implement. It doesn’t take long to administer, the language in the script is straightforward and easy to understand, and the administration is streamlined within Pathway. PCRS and Pathway provide a scientifically-backed mechanism for mitigating placebo response in a way that doesn’t significantly increase the burden on clinical sites or subjects.
To learn more about placebo response mitigation, download our whitepaper.
Cohen, E.A., Hassman, H.H., Walling, D.P., Wyka, K., Horan, W.P., Keefe, R.S.E., Grindell, V.M., Glass, S.J., Ball, R.R., Styczynski, J., Lobb, J.M., Ereshefsky, L. (2020, May) The Placebo-Control Reminder Script in Depression and Psychosis Trials: An Antidote for the Placebo and Nocebo Response. The American Society of Clinical Psychopharmacology (ASCP), Virtual Meeting
Cohen, E.A., Hassman, H.H., Walling, D.P., Hoover, S., Wyka, K. Ball, R.R., Joseph, A.V., Lobb, J.M., Hazzard-Rudolph, D., Ereshefsky, L. (2018, November) A First-Time Investigation of a Subject Intervention to Reduce the Placebo and Nocebo Effects: A Multicenter, Randomized, Single-Blind, All Placebo Study of a Placebo-Control Reminder Script for Subjects with Major Depression. CNS Summit, Boca Raton, FL