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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorFondation FondaMental

About this trial

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

Eligibility criteria

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • GynMDD
  • Placebo

Treatment groups

168 Participants
are divided into 2 treatment groups

Sponsors and collaborators