Join us at Health Research Day — June 6th at Canton Waterfront Park, Baltimore!   Learn More →
← Back to all trials
Recruiting 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

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07416747). StuddyBuddy aggregates publicly available trial information.