Finding studies
Finding studies
Take this into the appointment.
Saves the questions and what to expect into your notes, next to the visit they belong to.
Fabien Vinckier
CONTACT
Claire Jaffré
CONTACT
Lead
Centre Hospitalier St Anne
One hundred patients with a moderate to severe major depressive episode will be enrolled in this prospective multicenter study. Six visits will be scheduled within a year: * V0 (inclusion visit): verification of inclusion and exclusion criteria, information, and consent. * V1 (before randomization - baseline state): * Clinical evaluation using validated questionnaires for the severity of depression, quality of life, anhedonia, apathy, and cognitive dysfunction. * Neuro-cognitive evaluation using a battery of tests to explore motivation, emotion processing, belief construction, and their updating. Part of the tests will be performed during the functional MRI session. * Structural (anatomical) and functional MRI, ASL. * Blood samples. * Randomization and introduction of the new antidepressant will occur immediately after V1. To maximize acceptability by referring psychiatrists, dosage and co-prescriptions will be at the discretion of the psychiatrist in charge, but the assigned treatment will not be changed for 4 weeks (until V3). * V2 (7 days after the beginning of the new antidepressant - 'early response visit'): o Similar to V1. * V3 (28 days after the beginning of the new antidepressant - 'conventional response visit'): * Clinical evaluation using validated questionnaires for the severity of depression, quality of life, anhedonia, apathy, and cognitive dysfunction. * Blood samples * V4 (6 months after the beginning of the new antidepressant - 'remission visit'): * Clinical evaluation using validated questionnaires for the severity of depression, quality of life, anhedonia, apathy, and cognitive dysfunction. * Cognitive evaluation using a battery of tests to explore motivation, emotion processing, belief construction, and their updating. * Structural (anatomical) MRI, ASL * Blood samples * V5 (one year after the beginning of the new antidepressant - 'functional remission visit'): * Clinical evaluation using validated questionnaires for the severity of depression, quality of life, anhedonia, apathy, and cognitive dysfunction. 36 healthy volunteers without a history of neurologic or psychiatric disorder, matched for age, gender, and education will be included. They will perform V0-V2 (without MRI and blood sample at V2). Healthy volunteers will not receive any treatment as part of the research.
Age
18–any
Sex
ALL
Healthy volunteers
Accepted
