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

NCT07416747 | Not Yet Recruiting

• 1 other identifier: 2025-A00661-48
• Study Type: interventional
• Target: 168
• Locations: 1 country
• Sites: 1

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

Conditions

Depression; Depression Disorder; Depression in Adults

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

Outcome Measures

Primary Outcomes (1)

• Change in MADRS Score

  Assessment of depressive symptoms using the Montgomery-Åsberg Depression Rating Scale (MADRS).

  Baseline (V0) to Week 8 (V2)

Secondary Outcomes (6)

• Change in Digestive Symptom Score (WGO scale)

  Baseline (V0), Week 4 (V1), Week 8 (V2)

• Change in PHQ-9 Self-Reported Depression Score

  Weekly for 8 weeks

• Change in GSRS-IBS Digestive Symptom Score

  Weekly for 8 weeks

• Fecal Microbiota Metagenomic Profile (Shotgun Sequencing)

  Baseline (V0) and Week 8 (V2)

• Adverse Events Reporting

  Weekly until 8 week and at Week 4 (V1), Week 8 (V2)

Study Arms (2)

Supportive Psychotherapy + GynMDD

EXPERIMENTAL

Supportive Psychotherapy and Dietary Supplement

Dietary Supplement: GynMDD

Supportive Psychotherapy + Placebo

PLACEBO COMPARATOR

Supportive Psychotherapy and Placebo

Other: Placebo

Interventions

GynMDD DIETARY_SUPPLEMENT

Dietary Supplement: GynMDD (Sorolys®) Daily 2.5 g stick for 8 weeks Includes L-glutamine, Cavacurmin®, and Lacticaseibacillus rhamnosus GG

Supportive Psychotherapy + GynMDD

Placebo OTHER

Placebo for 8 weeks Identical stick without active ingredients; β-carotene added for color

Supportive Psychotherapy + Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Fondation FondaMental: lead
• GYNOV: collaborator

Study Sites (1)

Hôpital Albert Chenevier 40 rue de Mesly

Créteil, 94010, France

Location

MeSH Terms

Conditions

Depression; Psychological Well-Being

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Personal Satisfaction

Study Officials

• Marion LEBOYER, Pr

  Fondation FondaMental

  STUDY CHAIR

• FAUCHER Pierre, Dr

  GYNOV

  STUDY DIRECTOR

Central Study Contacts

Clinical Project Manager

CONTACT

+3314981326; laina.ndiaye@fondation-fondamental.org

Clinical Operation Lead

CONTACT

imene.benmohamed@fondation-fondamental.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants are assigned to two parallel groups: supportive psychotherapy plus GynMDD or supportive psychotherapy plus placebo.

Study Record Dates

• First Submitted: December 9, 2025
• First Posted: February 18, 2026
• Study Start: March 1, 2026
• Primary Completion (Estimated): November 1, 2027
• Study Completion (Estimated): November 1, 2027
• Last Updated: February 18, 2026

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)