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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This randomized, add-on study tests whether the dietary supplement GynMDD can improve depressive symptoms when combined with standard supportive psychotherapy in adults aged 18–65. Participants receive weekly psychotherapy for 8 weeks and take either GynMDD or a placebo daily, alongside regular GP visits and weekly self-assessments. The primary outcome is change in MADRS score, with secondary goals including digestive well-being and gut microbiota changes. The trial compares two groups to determine if GynMDD provides additional benefit beyond psychotherapy alone. Safety screening excludes those with high suicidal risk, current antidepressant use, or conditions contraindicating probiotics.

Why it matters

Who can join: the full rules

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

Where it's running

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

Study contacts

• Study coordinator: Clinical Project Manager
• Email: michelle.haddad@fondation-fondamental.org
• Phone: +3314981326

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.