NCT07416747

GynMDD Add-On to Supportive Psychotherapy in Mild to Moderate Depression

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.

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 168 (estimated)
• Sponsor: Fondation FondaMental · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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

Conditions

• Depression
• Depression Disorder
• Depression in Adults

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	GynMDD	Dietary Supplement: GynMDD (Sorolys®) Daily 2.5 g stick for 8 weeks Includes L-glutamine, Cavacurmin®, and Lacticaseibacillus rhamnosus GG
OTHER	Placebo	Placebo for 8 weeks Identical stick without active ingredients; β-carotene added for color

Timeline

• Start date: 2026-03-01
• Primary completion: 2027-11-01
• Completion: 2027-11-01
• First posted: 2026-02-18
• Last updated: 2026-02-18

Locations

1 site across 1 country: France