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

NCT07416747 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 168

Last updated 2026-02-18

No results posted yet for this study

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

Interventions

DIETARY_SUPPLEMENT

GynMDD

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

OTHER

Placebo

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

Sponsors & Collaborators

  • GYNOV

    collaborator INDUSTRY

  • Fondation FondaMental

    lead OTHER

Principal Investigators

  • Marion LEBOYER, Pr · Fondation FondaMental

  • FAUCHER Pierre, Dr · GYNOV

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-03-31
Primary Completion
2027-11-30
Completion
2027-11-30

Countries

  • France

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07416747 on ClinicalTrials.gov