Depression, Depression Disorder, Depression in Adults
Conditions
Keywords
Gut-Brain Axis, Gut Microbiota, GynMDD, Mild Depression, Moderate Depression, MADRS, Supportive Psychotherapy, Psychotherapy, Dietary Supplement, Probiotic Supplement, Real-World Study, Mental Health, Curcumin, L-Glutamine, Randomized Controlled Trial, PHQ-9
Brief 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
Interventions
DIETARY_SUPPLEMENTGynMDD
Dietary Supplement: GynMDD (Sorolys®) Daily 2.5 g stick for 8 weeks Includes L-glutamine, Cavacurmin®, and Lacticaseibacillus rhamnosus GG
OTHERPlacebo
Placebo for 8 weeks Identical stick without active ingredients; β-carotene added for color
Sponsors
Fondation FondaMental
GYNOV
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Intervention model description
Participants are assigned to two parallel groups: supportive psychotherapy plus GynMDD or supportive psychotherapy plus placebo.
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in MADRS Score | Baseline (V0) to Week 8 (V2) | Assessment of depressive symptoms using the Montgomery-Åsberg Depression Rating Scale (MADRS). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Digestive Symptom Score (WGO scale) | Baseline (V0), Week 4 (V1), Week 8 (V2) | Difference in scores on the World Gastroenterology Organization digestive health scale between baseline and follow-up visits. |
| Change in PHQ-9 Self-Reported Depression Score | Weekly for 8 weeks | Weekly PHQ-9 scores completed by participants through the digital platform to assess changes in depressive symptoms. |
| Change in GSRS-IBS Digestive Symptom Score | Weekly for 8 weeks | Weekly GSRS-IBS digestive symptom scores completed on the digital platform. |
| Fecal Microbiota Metagenomic Profile (Shotgun Sequencing) | Baseline (V0) and Week 8 (V2) | Presence of predictive microbiota signatures and evolution of gut microbiome composition. |
| Adverse Events Reporting | Weekly until 8 week and at Week 4 (V1), Week 8 (V2) | — |
| Proportion of participants requiring initiation of antidepressant therapy | Up to Week 8 (V2) | — |
Countries
France
Contacts
CONTACTClinical Project Manager
CONTACTClinical Operation Lead
STUDY_CHAIRMarion LEBOYER, Pr
Fondation FondaMental
STUDY_DIRECTORFAUCHER Pierre, Dr
GYNOV
Outcome results
None listed