GynMDD Add-On to Supportive Psychotherapy in Mild to Moderate Depression (NCT07416747) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
GynMDD Add-On to Supportive Psychotherapy in Mild to Moderate Depression
France168 participantsStarted 2026-03
Plain-language 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
Who can participate
Age range
18 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 clini…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.