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NCT07416747
GynMDD Add-On to Supportive Psychotherapy in Mild to Moderate Depression
Conditions: Depression, Depression Disorder, Depression in Adults
Sex: All
Ages: 18 Years – 65 Years
Healthy volunteers: No
Phase: NA
Enrollment: 168
Sponsor: Fondation FondaMental
Location: Hôpital Albert Chenevier 40 rue de Mesly Créteil
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
Eligibility Criteria
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
Source: ClinicalTrials.gov (NCT07416747). StuddyBuddy aggregates publicly available trial information.