Central monitoring of depression and anxiety symptoms reduces placebo responses in depression clinical trials: A post hoc exploratory analysis of data from the phase III CCT-004 trial of vortioxetine.

ABSTRACT:

Aim

Clinical trials of antidepressants often fail to demonstrate their efficacy versus placebo, suggesting that patient selection based on physician ratings of depression may contribute to a high placebo response.

Methods

In the CCT-004 trial of vortioxetine, central monitoring was employed to compare physician and patient ratings of depression and anxiety at baseline and over time to identify factors contributing to a large placebo response, as well as to explore the potential of a unique patient-rated clinical measure combining QIDS-J and Himorogi Self-rating Anxiety Scale (HSAS), to contribute to optimal patient selection at baseline and patient monitoring over time.

Results

The CCT-004 trial showed similar trends between the QIDS-J and MADRS (Montgomery-Åsberg Dep

SUBMITTER: Watanabe Y 

PROVIDER: S-EPMC9773757 | biostudies-literature | 2022 Dec

REPOSITORIES: biostudies-literature