Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT07416747

GynMDD Add-On to Supportive Psychotherapy in 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

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Conditions

Depression Behavior Behavioral Symptoms Depression Disorder Depression in Adults Personal Satisfaction Psychological Well-Being

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hôpital Albert Chenevier 40 rue de Mesly

Créteil, 94010, France

Location contact

CONTACT

[email protected]

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

GynMDD

Dietary Supplement

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

Placebo

Other

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

Primary outcomes

  1. Change in MADRS Score

    Time frame: Baseline (V0) to Week 8 (V2)

    Assessment of depressive symptoms using the Montgomery-Åsberg Depression Rating Scale (MADRS).

Secondary outcomes

  1. Change in Digestive Symptom Score (WGO scale)

    Time frame: Baseline (V0), Week 4 (V1), Week 8 (V2)

    Difference in scores on the World Gastroenterology Organization digestive health scale between baseline and follow-up visits.

  2. Change in PHQ-9 Self-Reported Depression Score

    Time frame: Weekly for 8 weeks

    Weekly PHQ-9 scores completed by participants through the digital platform to assess changes in depressive symptoms.

  3. Change in GSRS-IBS Digestive Symptom Score

    Time frame: Weekly for 8 weeks

    Weekly GSRS-IBS digestive symptom scores completed on the digital platform.

  4. Fecal Microbiota Metagenomic Profile (Shotgun Sequencing)

    Time frame: Baseline (V0) and Week 8 (V2)

    Presence of predictive microbiota signatures and evolution of gut microbiome composition.

  5. Adverse Events Reporting

    Time frame: Weekly until 8 week and at Week 4 (V1), Week 8 (V2)

  6. Proportion of participants requiring initiation of antidepressant therapy

    Time frame: Up to Week 8 (V2)

Study contacts

Contact information is provided by the study sponsor or research team.

Clinical Operation Lead

CONTACT

[email protected]

Clinical Project Manager

CONTACT

[email protected]

+3314981326

Sponsors and collaborators

Lead sponsor

Fondation FondaMental

Other

Collaborators

  • GYNOV

Registry information

Official study 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.

Acronym: SWING

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Feb 18, 2026
Registry last updated
Feb 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.