Status:
NOT_YET_RECRUITING
Study of Electrophysiological Markers of Antidepressants in Major Depressive Disorder
Lead Sponsor:
Centre Psychothérapique de Nancy
Conditions:
Major Depressive Disorder
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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 tr...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2026
Estimated Enrollment :
108 Patients enrolled
Trial Details
Trial ID
NCT06532604
Start Date
June 1 2025
End Date
July 1 2026
Last Update
May 25 2025
Active Locations (1)
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1
Centre Psychothérapique de Nancy
Laxou, Nancy, France, 54520