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探索视网膜电图作为预测和监测重度抑郁症患者对抗抑郁药治疗反应的生物标志物:MESANTIDEP试验的研究方案

Exploring the ElectroRetinoGraphy as a biomarker for predicting and monitoring therapeutic response to antidepressants in major depressive disorder: study protocol for the MESANTIDEP trial.

作者信息

de Deus Marie, Petit Charlotte, Moulard Marie, Cosker Eve, Mellouki Bendimred Naoual, Albuisson Éliane, Maruani Julia, Geoffroy Pierre-Alexis, Schwitzer Thomas

机构信息

Pôle Hospitalo-Universitaire de Psychiatrie d'Adulte et d'Addictologie du Grand Nancy, Centre Psychothérapique de Nancy, Laxou, France.

Délégation à la Recherche Clinique et à l'Innovation (DRCI), Unité de Méthodologie, Data Management et Statistique (UMDS), Centre Hospitalier Régional et Universitaire (CHRU) de Nancy, Nancy, France.

出版信息

Front Psychiatry. 2025 Apr 25;16:1501166. doi: 10.3389/fpsyt.2025.1501166. eCollection 2025.

DOI:10.3389/fpsyt.2025.1501166
PMID:40352365
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC12061921/
Abstract

BACKGROUND

Major depressive disorder (MDD) is a frequent and highly debilitating condition for which current antidepressant treatments show limited effectiveness. In addition, their implementation requires one or more trial-and-error processes, which involves months of untreated illness. Achieving faster efficacy by identifying the most adapted treatment for each patient as the first line treatment could significantly reduce MDD-related morbidity and mortality while enhancing patients' quality of life. To achieve this goal, there is a need to identify markers for predicting and monitoring therapeutic response to antidepressants.

METHODS

The MESANTIDEP study is designed to identify electroretinographic (ERG) biomarkers that can predict the therapeutic response at 12 weeks to the two main classes of antidepressants prescribed as first-line treatments for MDD: Selective Serotonin Reuptake Inhibitors (SSRIs) and alpha-2 adrenergic receptor antagonists (α2-antagonists). Secondly, the study aims to explore the relationship between ERG measurements and therapeutic response at 6 and 12 weeks in MDD patients treated with SSRIs or α2-antagonists. To this end, patients diagnosed with MDD and needing to start an antidepressant from the SSRI or α2-antagonist classes will be enrolled. At the inclusion visit, prior to starting their antidepressant treatment, patients will undergo various assessments, including clinical and sleep questionnaires, as well as ERG tests. Patients will initiate their antidepressant treatment the day after the inclusion visit. Subsequent evaluations, identical to those at baseline, will be conducted 6 and 12 weeks afterwards to monitor therapeutic response to antidepressants.

DISCUSSION

The MESANTIDEP study will contribute to identify ERG markers predicting and monitoring the therapeutic response to antidepressants. If such markers are highlighted, it is intended to help clinicians in the treatment management of MDD patients. ERG measurements being easy to perform and accessible to all, they could be integrated into a multimodal treatment approach in routine clinical practice. It would enable more rapid therapeutic intervention tailored to each patient could reduce the functional impact of the disease, improve patients' quality of life, and decrease MDD-associated morbidity and mortality.

CLINICAL TRIAL REGISTRATION

Clinicaltrials.gov, identifier NCT06532604.

摘要

背景

重度抑郁症(MDD)是一种常见且使人极度衰弱的疾病,目前的抗抑郁治疗效果有限。此外,这些治疗的实施需要一个或多个试错过程,这意味着患者有几个月的时间处于未治疗状态。通过为每位患者确定最适合的一线治疗方案来更快地实现疗效,可显著降低与MDD相关的发病率和死亡率,同时提高患者的生活质量。为实现这一目标,需要确定预测和监测对抗抑郁药治疗反应的标志物。

方法

MESANTIDEP研究旨在确定视网膜电图(ERG)生物标志物,这些标志物可预测作为MDD一线治疗药物的两类主要抗抑郁药在12周时的治疗反应:选择性5-羟色胺再摄取抑制剂(SSRIs)和α-2肾上腺素能受体拮抗剂(α2-拮抗剂)。其次,该研究旨在探讨接受SSRIs或α2-拮抗剂治疗的MDD患者在6周和12周时ERG测量值与治疗反应之间的关系。为此,将招募被诊断为MDD且需要开始使用SSRIs或α2-拮抗剂类抗抑郁药的患者。在纳入访视时,即在开始抗抑郁治疗前,患者将接受各种评估,包括临床和睡眠问卷以及ERG测试。患者将在纳入访视后的第二天开始抗抑郁治疗。在6周和12周后将进行与基线相同的后续评估,以监测对抗抑郁药的治疗反应。

讨论

MESANTIDEP研究将有助于确定预测和监测对抗抑郁药治疗反应的ERG标志物。如果发现了此类标志物,旨在帮助临床医生对MDD患者进行治疗管理。ERG测量易于进行且所有人都可获得,它们可被纳入常规临床实践中的多模式治疗方法。这将能够为每位患者进行更快速的治疗干预,减少疾病的功能影响,改善患者的生活质量,并降低与MDD相关的发病率和死亡率。

临床试验注册

Clinicaltrials.gov,标识符NCT06532604。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/ae81/12061921/2be273a1a7d4/fpsyt-16-1501166-g003.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/ae81/12061921/7ab9ef1ecc76/fpsyt-16-1501166-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/ae81/12061921/671b50965179/fpsyt-16-1501166-g002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/ae81/12061921/2be273a1a7d4/fpsyt-16-1501166-g003.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/ae81/12061921/7ab9ef1ecc76/fpsyt-16-1501166-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/ae81/12061921/671b50965179/fpsyt-16-1501166-g002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/ae81/12061921/2be273a1a7d4/fpsyt-16-1501166-g003.jpg

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