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GynMDD Add-On to Supportive Psychotherapy in Mild to Moderate Depression
Sponsor: Fondation FondaMental
Summary
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
Official title: Multicenter Interventional Real-world Study Evaluating the Impact of the Dietary Supplement GynMDD Administered as an add-on to Supportive Psychotherapy in Patients With Mild to Moderate Depression.
Key Details
Gender
All
Age Range
18 Years - 65 Years
Study Type
INTERVENTIONAL
Enrollment
168
Start Date
2026-03
Completion Date
2027-11
Last Updated
2026-02-18
Healthy Volunteers
No
Interventions
GynMDD
Dietary Supplement: GynMDD (Sorolys®) Daily 2.5 g stick for 8 weeks Includes L-glutamine, Cavacurmin®, and Lacticaseibacillus rhamnosus GG
Placebo
Placebo for 8 weeks Identical stick without active ingredients; β-carotene added for color
Locations (1)
Hôpital Albert Chenevier 40 rue de Mesly
Créteil, France