Item response theory in early phase clinical trials: Utilization of a reference model to analyze the Montgomery-Asberg Depression Rating Scale.

ABSTRACT: In clinical trials, Montgomery-Åsberg Depression Rating Scale (MADRS) questionnaire data are added up to total scores before analysis, assuming equal contribution of each separate question. Item Response Theory (IRT)-based analysis avoids this by using individual question responses to determine the latent variable (ψ), which represents a measure of depression severity. However, utilization of IRT in early phase trials remains difficult, because large datasets are needed to develop IRT models. Therefore, we aimed to evaluate the application and assumptions of a reference IRT model for analysis of an early phase trial. A cross-over, placebo-controlled study investigating the effect of intravenous racemic ketamine on MADRS scores in patients with treatment-resistant major depressive disorder

SUBMITTER: Otto ME 

PROVIDER: S-EPMC10583236 | biostudies-literature | 2023 Oct

REPOSITORIES: biostudies-literature