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

RecruitingNAAges 18 Years - 65 YearsAllFondation FondaMental
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In plain words

What the trial is, and whether it could suit you

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

Sign in to get the eligibility rules as simple questions to take to your doctor.

📋 Eligibility rules (as published)
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
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What it tests

  • GynMDD
  • Placebo
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Where

1 site
Hôpital Albert Chenevier 40 rue de Mesly
Créteil, France
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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