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

Sponsor: Fondation FondaMental • ClinicalTrials.gov ID: NCT07416747

Registry updated: 2026-10-07

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Description

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

Interventions

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

Eligibility criteria

Inclusion Criteria: * Adults aged 18 to 65 years, inclusive * The main reason for consultation is a suspected depressive episode * MADRS score between 15 and 34, indicating mild to moderate depression * No suicidal risk, defined as a score of 0 on item 10 of the MADRS scale * Body Mass Index (BMI) between 19 and 29 (inclusive) * Signed informed consent, confirming that the participant understands the purpose and requirements of the study and agrees to comply with the procedures (including scheduled supportive psychotherapy sessions) * Affiliation with the French national health insurance system or beneficiary of such coverage Exclusion Criteria: * History of severe psychiatric disorders or currently undergoing supportive psychotherapy * Confirmed suicidal risk, defined as a score between 1 and 6 on MADRS item 10 * Current treatment with antidepressants (AD) * MADRS score \> 34 * Conditions in which probiotic administration is not recommended (e.g., immunodeficiency, presence of a venous catheter) * Allergy to any component of the placebo or the GynMDD dietary supplement * Current consumption of probiotic-based dietary supplements * Recent infectious episodes that may require antibiotic therapy * Current treatment with anxiolytics * Long-term chronic anti-inflammatory treatment * Alcohol abuse, defined as a consumption of 10 standard drinks per week or more * Use of illicit drugs or substances of abuse * Inability to provide informed consent * Participation in another clinical study within the past 12 months * Pregnant or breastfeeding women * Patients without health insurance * Individuals under legal protection, guardianship, trusteeship, or any other protective measure

Conditions

Depression Depression Disorder Depression in Adults

Locations

Hôpital Albert Chenevier 40 rue de Mesly — Créteil, France

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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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