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

Starting soon · Not applicable · Has a placebo group

Conditions studied: Depression, Depression Disorder, Depression in Adults

In brief

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

Key facts

Study ID

NCT07416747

Run by

Fondation FondaMental

People needed

168

Starts

2026-03-01

Expected to finish

2027-11-01

Last updated by the study team

2026-02-18

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Hôpital Albert Chenevier 40 rue de Mesly — Créteil, France

Full record on ClinicalTrials.gov

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