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临床试验/NCT06532604
NCT06532604尚未招募不适用

Study of Electrophysiological Markers of Antidepressants in Major Depressive Disorder

Centre Psychothérapique de Nancy2 个研究点 分布在 1 个国家目标入组 108 人开始时间: 2026年9月1日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
108
试验地点
2
主要终点
ERG amplitudes at baseline

研究概览

简要总结

Major depressive disorder (MDD) is a frequent and particularly disabling disorder. The efficacy of current antidepressants is limited, with 50-60% of patients not achieving a sufficient response to treatment. Indeed, to date, clinicians are unable to predict the therapeutic response a patient will obtain to a given molecule. This often results in several trials of a molecule until clinical efficacy is achieved, with a delay of several months of untreated disease. Achieving faster efficacy by targeting the right molecule for each patient in the 1st line of treatment would limit the morbidity and mortality induced by MDD, and its impact on quality of life. To achieve this goal rapidly, there is a need to identify markers for predicting and monitoring therapeutic response to antidepressants.

This is why the MESANTIDEP study aims to propose electroretinographic (ERG) biomarkers for predicting therapeutic response at 12 weeks for the two main therapeutic classes of antidepressants prescribed as 1st-line treatment for major depressive disorder: Selective Serotonin Reuptake Inhibitors (SSRIs) and alpha-2 adrenergic receptor antagonists (alpha-2 antagonists). Secondly, investigators will look for ERG biomarkers of therapeutic response at 6 weeks, and 12 weeks, for these two therapeutic classes of antidepressants.

For this purpose, patients diagnosed with MDD and requiring the initiation of an antidepressant - of the SSRI or alpha-2-antagonist class - will be included. At their inclusion visit, patients will not yet have started their antidepressant treatment and will undergo various tests. These include clinical questionnaires, sleep assessment questionnaires and three ERG tests (fERG, PERG and mfERG). Antidepressant treatment can be started by the patient the day after the inclusion visit. 6 and 12 weeks later, the patient undergoes the same tests as at the inclusion visit to monitor their therapeutic response to the prescribed antidepressant. The identification of electrophysiological markers predictive of therapeutic response to antidepressants is intended to help clinicians in the treatment of MDD patients. More rapid therapeutic intervention tailored to each patient will limit the functional impact, improve quality of life and reduce the morbidity and mortality associated with the disease. These electrophysiological ERG measurements are easy to perform. They are therefore accessible to all, and can be used, through a multimodal approach, in routine clinical practice.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Diagnosis of a current unipolar depressive episode according to DSM-V criteria
  • Prescription of antidepressant treatment - SSRI or alpha-2 antagonist - by the psychiatrist or referring physician for the current depressive episode
  • Age 18 or more
  • Affiliation with a welfare scheme and native French speakers
  • Complete information on the study received and written informed consent signed

排除标准

  • Diagnosis of a progressive psychiatric disorder (except MDD and anxiety disorder) according to DSM-V criteria
  • Seasonal character of the depression
  • Current antidepressant treatment
  • Recommended antidepressant treatment other than SSRI or alpha-2 antagonist
  • High suicide risk
  • Retinal or ophtalmologic pathology affecting visual acuity as assessed by the Monoyer scale.
  • History of head trauma, epilepsy or other neurological disorders
  • Participation in another interventional study (including exclusion period)
  • Intellectual disability leading to difficulty participating or impossibility or inability to understand the information provided on the study.
  • Persons cited in Articles L. 1121-5 to L. 1121-8 of the French Public Health Code: pregnant women, parturient or breastfeeding mothers, persons deprived of their liberty by a judicial or administrative decision, persons under psychiatric care under duress, persons admitted to a health or social establishment for other goals than research, minors, adults subject to a legal protection, adults who are unable to express their consent and who are not subject to a legal protection measure.
  • Criteria incompatible with the use of the ERG device: open wound in an area covered or enveloped by the device; implantable medical device (e.g. pacemaker); user at high risk of contagion

结局指标

主要结局

ERG amplitudes at baseline

时间窗: Baseline (D0)

Modification of amplitude measured with flash, pattern and multifocal electroretinogram amplitude in microvolt

Montgomery Asberg Depression Rating Scale score differences between D0 and W12

时间窗: Baseline (D0) and 12 weeks after baseline (W12)

A subject will be declared responder (decrease greater than or equal to 8 points between D0 and W12) or non-responder (score difference less than 8 points or increase between D0 and W12). We obtain binary data (responder/non-responder).

ERG implicit times at baseline

时间窗: Baseline (D0)

Modification of implicit time measured with flash, pattern and multifocal electroretinogram implicit time in millisecond

次要结局

  • ERG implicit time(12 weeks after baseline (W12))
  • ERG amplitudes(12 weeks after baseline (W12))
  • Montgomery Asberg Depression Rating Scale (MADRS) score differences(6 weeks after baseline (W6) and 12 weeks after baseline (W12))

研究者

发起方
Centre Psychothérapique de Nancy
申办方类型
Other
责任方
Sponsor

研究点 (2)

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