NCT07416747 GynMDD Add-On to Supportive Psychotherapy in Mild to Moderate Depression
| NCT ID | NCT07416747 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Fondation FondaMental |
| Condition | Depression |
| Study Type | INTERVENTIONAL |
| Enrollment | 168 participants |
| Start Date | 2026-03-24 |
| Primary Completion | 2027-11 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 168 participants in total. It began in 2026-03-24 with a primary completion date of 2027-11.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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
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
Contact & Investigator
Marion LEBOYER, Pr
STUDY CHAIR
Fondation FondaMental
Frequently Asked Questions
Who can join the NCT07416747 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 65 Years, studying Depression. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07416747 currently recruiting?
Yes, NCT07416747 is actively recruiting participants. Contact the research team at michelle.haddad@fondation-fondamental.org for enrollment information.
Where is the NCT07416747 trial being conducted?
This trial is being conducted at Créteil, France.
Who is sponsoring the NCT07416747 clinical trial?
NCT07416747 is sponsored by Fondation FondaMental. The principal investigator is Marion LEBOYER, Pr at Fondation FondaMental. The trial plans to enroll 168 participants.
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