About this trial
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
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- GynMDD
- Placebo
Treatment groups
Sponsors and collaborators
Fondation FondaMental
Lead sponsor
GYNOV
Collaborator