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Not yet recruiting NCT07416747

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

No phase Interventional Depression Depression Disorder Depression in Adults

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: GynMDD, Placebo.
Who it may be relevant to
Registry conditions: Depression, Depression Disorder, Depression in Adults. Basic parameters: 18 years — 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

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.

Overview

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

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

Primary outcome measures

  • Change in MADRS Score [Time frame: Baseline (V0) to Week 8 (V2)]
Secondary outcome measures (6)
  • Change in Digestive Symptom Score (WGO scale) [Time frame: Baseline (V0), Week 4 (V1), Week 8 (V2)]
  • Change in PHQ-9 Self-Reported Depression Score [Time frame: Weekly for 8 weeks]
  • Change in GSRS-IBS Digestive Symptom Score [Time frame: Weekly for 8 weeks]
  • Fecal Microbiota Metagenomic Profile (Shotgun Sequencing) [Time frame: Baseline (V0) and Week 8 (V2)]
  • Adverse Events Reporting [Time frame: Weekly until 8 week and at Week 4 (V1), Week 8 (V2)]
  • Proportion of participants requiring initiation of antidepressant therapy [Time frame: Up to Week 8 (V2)]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Quadruple blind
Primary purpose
Treatment

Study locations

France · 1 center
  • Hôpital Albert Chenevier 40 rue de Mesly — Créteil

Identifiers

NCT: NCT07416747 · 2025-A00661-48 · 2025-A00661-48

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗