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Studies

Interventional Recruiting

NCT07416747 on ClinicalTrials.gov

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

Official title: 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.

  • Sponsor: Fondation FondaMental
  • Collaborators: GYNOV
  • Enrollment: 168 (Estimated)
  • Study start: 2026-03-24 (Actual)
  • Primary completion: 2027-11-01 (Estimated)
  • Study completion: 2027-11-01 (Estimated)
  • Allocation: Randomized
  • InterventionModel: Parallel
  • InterventionModelDescription: Participants are assigned to two parallel groups: supportive psychotherapy plus GynMDD or supportive psychotherapy plus placebo.
  • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • PrimaryPurpose: Treatment

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

Intervention / Treatment

  • Dietary Supplement: GynMDD
  • Other: Placebo

Primary Outcome Measures

  • Change in MADRS Score (Baseline (V0) to Week 8 (V2))
    Assessment of depressive symptoms using the Montgomery-Ã…sberg Depression Rating Scale (MADRS).

Countries

France

Locations and Investigators

  • Hôpital Albert Chenevier 40 rue de Mesly, Créteil, France (Recruiting)

Study Officials

  • Marion LEBOYER, Pr (Study Chair) — Fondation FondaMental
  • FAUCHER Pierre, Dr (Study Director) — GYNOV