Overview
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
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
