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Life sciences · Interventional Study
ClinicalTrials.gov · October 7, 2026
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Interventional Study.
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Registry record from ClinicalTrials.gov (NCT07416747). This is a study registration, not published results. Lead sponsor: Fondation FondaMental. Recruitment status: RECRUITING. Phase: NA. Study type: INTERVENTIONAL. Enrollment: 168 participants (ESTIMATED). Conditions: Depression, Depression Disorder, Depression in Adults. Interventions: DIETARY_SUPPLEMENT: GynMDD; OTHER: Placebo. Primary outcome measures: Change in MADRS Score , Baseline (V0) to Week 8 (V2). Brief 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