The goal of this clinical trial is to learn whether the dietary supplement GynMDD, when taken as an add-on to supportive psychotherapy, can improve symptoms of mild to moderate depression in adults aged 18 to 65. The main questions it aims to answer are: Does adding GynMDD to supportive psychotherapy lead to a greater reduction in depressive symptoms (measured by the MADRS scale) compared with supportive psychotherapy plus placebo? Does the supplement also improve digestive well-being and influence gut microbiota profiles over the course of treatment? Researchers will compare patients receiving supportive psychotherapy + GynMDD to those receiving supportive psychotherapy + placebo to see if GynMDD provides additional benefits beyond standard care. Participants will: * Attend regular appointments with their general practitioner * Complete one supportive psychotherapy session per week for 8 weeks * Take a daily dose of GynMDD or placebo * Complete weekly self-assessment questionnaires on mood, digestive symptoms, and any side effects via a mobile app * Provide two stool samples (at the start and end of the study) for microbiota analysis
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
168
Hôpital Albert Chenevier 40 rue de Mesly
Créteil, France
Change in MADRS Score
Assessment of depressive symptoms using the Montgomery-Åsberg Depression Rating Scale (MADRS).
Time frame: Baseline (V0) to Week 8 (V2)
Change in Digestive Symptom Score (WGO scale)
Difference in scores on the World Gastroenterology Organization digestive health scale between baseline and follow-up visits.
Time frame: Baseline (V0), Week 4 (V1), Week 8 (V2)
Change in PHQ-9 Self-Reported Depression Score
Weekly PHQ-9 scores completed by participants through the digital platform to assess changes in depressive symptoms.
Time frame: Weekly for 8 weeks
Change in GSRS-IBS Digestive Symptom Score
Weekly GSRS-IBS digestive symptom scores completed on the digital platform.
Time frame: Weekly for 8 weeks
Fecal Microbiota Metagenomic Profile (Shotgun Sequencing)
Presence of predictive microbiota signatures and evolution of gut microbiome composition.
Time frame: Baseline (V0) and Week 8 (V2)
Adverse Events Reporting
Time frame: Weekly until 8 week and at Week 4 (V1), Week 8 (V2)
Proportion of participants requiring initiation of antidepressant therapy
Time frame: Up to Week 8 (V2)
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