Study of Electrophysiological Markers of Antidepressants in Major Depressive Disorder

Plain English Summary

Study of Electrophysiological Markers of Antidepressants in Major Depressive Disorder is a Not Applicable clinical trial sponsored by Centre Psychothérapique de Nancy studying Major Depressive Disorder. Tests ERG to predict response to antidepressants for depression. For adults diagnosed with depression and starting new SSRI or alpha-2 antagonist treatment. Involves baseline tests and follow-ups at 6 and 12 weeks. No randomization; parallel design with no masking. The trial aims to enroll 108 participants.

Official Summary

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 elect

Who Can Participate

Here is what you need to know about eligibility for this trial. 18 years or older, diagnosed with depression, and able to speak French. Cannot have progressive psychiatric disorders, current antidepressant treatment, or other exclusions listed. This trial is studying Major Depressive Disorder, so participants generally need a confirmed diagnosis.

What They're Measuring

Measures ERG to assess response, which could help tailor treatment for better outcomes. The specific primary outcome measures are: ERG amplitudes at baseline (Baseline (D0)); ERG implicit times at baseline (Baseline (D0)); Montgomery Asberg Depression Rating Scale score differences between D0 and W12 (Baseline (D0) and 12 weeks after baseline (W12)). These endpoints are how researchers determine whether the treatment is effective and will form the basis of any future regulatory submissions.

About This Phase

This study does not have a traditional clinical phase designation. It may be an observational study that follows patients without intervening in their care, an expanded access or compassionate use program, or other non-interventional research. These studies contribute valuable data about disease progression, treatment patterns, and patient outcomes.

Why This Trial Matters

This trial aims to identify biomarkers for predicting antidepressant response, potentially improving treatment outcomes for depression. This research targets Major Depressive Disorder, where improved treatment options are needed.

Investor Insight

Addresses a significant unmet need in depression treatment, with a large market and growing interest in personalized medicine.

Is This Trial Right for Me?

Ask your doctor if you are diagnosed with depression and need to start a new antidepressant. Expect baseline tests and follow-ups at 6 and 12 weeks. The trial is being conducted at 1 site. Always discuss clinical trial participation with your healthcare provider before making any decisions. This information is for educational purposes only and is not medical advice.

AI-generated analysis for educational purposes only. This is not medical advice. Discuss clinical trial participation with your doctor. Data sourced from ClinicalTrials.gov.

Study Design

• Study Type: INTERVENTIONAL
• Allocation: NON_RANDOMIZED
• Model: PARALLEL
• Masking: NONE
• Enrollment: 108 participants

Interventions

• DEVICE: Electroretinography (ERG) — ERG are specifically carried out for research. They are performed in Nancy with the MonPackOne device developed by Metrovision for participants at center n°1, and in Paris with the RETeval device developed by LKS Technologie for participants at center n°2. Both devices comply with ISCEV standard and are CE marked. They enable the reccord of Pattern ERG, Flash ERG and Multifocal ERG using corneal and skin electrodes, or Sensor Strip skin electrodes only, for the Nancy and Paris centers respective

Primary Outcomes

• ERG amplitudes at baseline (Baseline (D0))
• ERG implicit times at baseline (Baseline (D0))
• Montgomery Asberg Depression Rating Scale score differences between D0 and W12 (Baseline (D0) and 12 weeks after baseline (W12))

Secondary Outcomes

• ERG amplitudes (Baseline (D0))
• ERG amplitudes (6 weeks after baseline (W6))
• ERG amplitudes (12 weeks after baseline (W12))
• ERG implicit time (Baseline (D0))
• ERG implicit time (6 weeks after baseline (W6))

Full Eligibility Criteria

Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Trial Locations

• Centre Psychothérapique de Nancy, Laxou, Nancy, France

Frequently Asked Questions

Related Conditions

• Major Depressive Disorder
• Antidepressant efficacy
• Personalized medicine
• Depression treatment

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