Mild-to-moderate depressive symptoms impact on self-reported outcome measures in clinical trials for neurodegenerative diseases

作者：Christine Girges, Nirosen Vijiaratnam, Alexa King, Grace Auld, Rachel McComish, Kashfia Chowdhury, Gareth Ambler, Kate Maclagan, Patricia Limousin, Dilan Athauda, Huw R. Morris, Vincenzo Libri, Thomas Foltynie, The Exenatide PD3 and MSA Trials Consortia · 发表于：Clinical Trials · 年份：2025 · DOI：10.1177/17407745251387571 · 被引用次数：1 · 研究领域：Treatment of Major Depression、Tryptophan and brain disorders、Dementia and Cognitive Impairment Research

INTRODUCTION: Depression can be an intrinsic part of neurodegeneration, or a reaction to the onset of motor or non-motor disability. Depression can also adversely influence an individual's perception of their disease, independently of its severity or impact on function. Participant-reported outcome measures are recognised as an important adjunct to objective clinical trial data. Although severe depression is a frequent contraindication for trial participation, mild-to-moderate depressive symptoms could potentially influence the outcome of such questionnaires. We aimed to explore this within two interventional trials for Parkinson's disease (Exenatide PD3; NCT04232969) and multiple system atrophy (Exenatide MSA; NCT04431713). METHODS: Prior to investigational drug exposure, participants completed either the Patient Health Questionnaire or Beck Depression Inventory-II, which allowed us to dichotomise them into two groups (normal or mild-to-moderately elevated burden of depressive symptoms). Participants with Parkinson's self-completed the Movement Disorder Society Sponsored Revision of the Unified Parkinson's disease Rating Scale Parts 1b and 2, Parkinson's Disease Questionnaire-39, Non-motor Symptoms Scale and EQ-5D-5L, while participants with multiple system atrophy self-completed a Quality of Life scale and had assistance with completing the Unified Multiple System Atrophy Rating Scale Part 1. The Movement Disorder Society Sponsored Revision of the Unified Parkinson's Diseas...