GynMDD Add-On to Supportive Psychotherapy in Mild to Moderate Depression (SWING)

Multicenter Interventional Real-world Study Evaluating the Impact of the Dietary Supplement GynMDD Administered as an add-on to Supportive Psychotherapy in Patients With Mild to Moderate Depression.

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

Study Overview

• Status: Not yet recruiting
• Conditions: Depression; Depression in Adults; Depression Disorder
• Intervention / Treatment: Dietary supplement: GynMDD; Other: Placebo

• Study Type: Interventional
• Enrollment (Estimated): 168
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Clinical Project Manager; Phone Number: +3314981326; Email: laina.ndiaye@fondation-fondamental.org
• Study Contact Backup: Name: Clinical Operation Lead; Email: imene.benmohamed@fondation-fondamental.org

Study Locations

• France
  • Créteil, France, 94010
    • Hôpital Albert Chenevier 40 rue de Mesly
    • Contact: Email: swing@fondation-fondamental.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Supportive Psychotherapy + GynMDD; Supportive Psychotherapy and Dietary Supplement	Dietary supplement: GynMDD; Dietary Supplement: GynMDD (Sorolys®) Daily 2.5 g stick for 8 weeks Includes L-glutamine, Cavacurmin®, and Lacticaseibacillus rhamnosus GG
Placebo Comparator: Supportive Psychotherapy + Placebo; Supportive Psychotherapy and Placebo	Other: Placebo; Placebo for 8 weeks Identical stick without active ingredients; β-carotene added for color

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in MADRS Score	Assessment of depressive symptoms using the Montgomery-Åsberg Depression Rating Scale (MADRS).	Baseline (V0) to Week 8 (V2)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Digestive Symptom Score (WGO scale)	Difference in scores on the World Gastroenterology Organization digestive health scale between baseline and follow-up visits.	Baseline (V0), Week 4 (V1), Week 8 (V2)
Change in PHQ-9 Self-Reported Depression Score	Weekly PHQ-9 scores completed by participants through the digital platform to assess changes in depressive symptoms.	Weekly for 8 weeks
Change in GSRS-IBS Digestive Symptom Score	Weekly GSRS-IBS digestive symptom scores completed on the digital platform.	Weekly for 8 weeks
Fecal Microbiota Metagenomic Profile (Shotgun Sequencing)	Presence of predictive microbiota signatures and evolution of gut microbiome composition.	Baseline (V0) and Week 8 (V2)
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)

Collaborators and Investigators

• Sponsor: Fondation FondaMental
• Collaborators: GYNOV
• Investigators: Study Chair: Marion LEBOYER, Pr, Fondation FondaMental; Study Director: FAUCHER Pierre, Dr, GYNOV

Study record dates

Study Major Dates

• Study Start (Estimated): March 1, 2026
• Primary Completion (Estimated): November 1, 2027
• Study Completion (Estimated): November 1, 2027

Study Registration Dates

• First Submitted: December 9, 2025
• First Submitted That Met QC Criteria: February 13, 2026
• First Posted (Actual): February 18, 2026

Study Record Updates

• Last Update Posted (Actual): February 18, 2026
• Last Update Submitted That Met QC Criteria: February 13, 2026
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Keywords: Mental Health; Randomized Controlled Trial; Psychotherapy; Curcumin; Gut Microbiota; Dietary Supplement; L-Glutamine; Supportive Psychotherapy; MADRS; Gut-Brain Axis; PHQ-9; Real-World Study; Probiotic Supplement; Mild Depression; GynMDD; Moderate Depression
• Additional Relevant MeSH Terms: Behavioral Symptoms; Behavior; Personal Satisfaction; Depression; Psychological Well-Being
• Other Study ID Numbers: 2025-A00661-48 (Other Identifier: IDRCB)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No