This study was done to evaluate the efficacy of the PCRS in a cohort of patients with MDD or a psychotic disorder who had at least moderate levels of depression. It was hypothesized that participants who received the PCRS would show a smaller decrease in depression than those who did not receive the PCRS. The number of adverse events (i.e., nocebo effect) was also lower in the PCRS group, particularly in the first week of the study.Nocebo effects substantially impact adherence and study withdrawal rates, further complicating efforts to statistically detect drug-placebo differences and bring potentially helpful compounds to market.
Participants who were included in this study were informed that they would participate in a 2-week randomized clinical trial with a 50% chance of receiving either an experimental antidepressant medication or placebo. In actuality, all participants received placebo. Participants randomly assigned to receive the PCRS (n = 70) reported significantly smaller reductions (i.e., less placebo response) in depression than those who did not receive the PCRS (n = 67). The magnitude of this effect was medium (Cohen’s d = 0.40) and was not significantly impacted by diagnostic status.
The PCRS approach is also particularly amenable for tailored use in trials that incorporate electronic Clinical Outcome Assessment platforms. For example, the PCRS can be easily incorporated within a rater surveillance vendor’s tablet and can be verified as having been read to participants before administration of the primary efficacy scale.
As a conclusion we can say that enhancing signal detection, such procedures may help drug developers progress compounds to faster approval and reach patients who are suffering sooner.