DepressionSWINGNCT07416747
GynMDD Add-On to Supportive Psychotherapy in Mild to Moderate Depression
A study testing GynMDD in people with Depression and Depression Disorder, run by Fondation FondaMental at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Depression, Depression Disorder, Depression in Adults
- What is being tested?
- GynMDD
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 168 participants
- Where
- 1 siteFrance
- Study dates
- 24 Mar 2026to Nov 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 17Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Clinical Operation Director contact
France1 site, 1 recruiting
- Recruiting
Hôpital Albert Chenevier 40 rue de Mesly
Créteil, 94010
swing@fondation-fondamental.org
About this study
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.
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?
Read more
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
- Being tested
- GynMDD, Placebo
- Keywords
- Gut-Brain Axis, Gut Microbiota, GynMDD, Mild Depression, Moderate Depression, MADRS, Supportive Psychotherapy, Psychotherapy, Dietary Supplement, Probiotic Supplement, Real-World Study, Mental Health, Curcumin, L-Glutamine, Randomized Controlled Trial, PHQ-9
- Medical subject headings
- Depression, Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GynMDDDietary supplement
Dietary Supplement: GynMDD (Sorolys®) Daily 2.5 g stick for 8 weeks Includes L-glutamine, Cavacurmin®, and Lacticaseibacillus rhamnosus GG
PlaceboOther
Placebo for 8 weeks Identical stick without active ingredients; β-carotene added for color
| Study group | Role | What they receive |
|---|---|---|
| Supportive Psychotherapy + GynMDD | Experimental | Supportive Psychotherapy and Dietary Supplement Receives: Dietary Supplement: GynMDD |
| Supportive Psychotherapy + Placebo | Placebo comparator | Supportive Psychotherapy and Placebo Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in MADRS Score
Assessment of depressive symptoms using the Montgomery-Åsberg Depression Rating Scale (MADRS).
Measured: Baseline (V0) to Week 8 (V2)
Secondary outcomes (6)
Change in Digestive Symptom Score (WGO scale)
Difference in scores on the World Gastroenterology Organization digestive health scale between baseline and follow-up visits.
Measured: Baseline (V0), Week 4 (V1), Week 8 (V2)
Change in PHQ-9 Self-Reported Depression Score
Weekly PHQ-9 scores completed by participants through the digital platform to assess changes in depressive symptoms.
Measured: Weekly for 8 weeks
Change in GSRS-IBS Digestive Symptom Score
Weekly GSRS-IBS digestive symptom scores completed on the digital platform.
Measured: Weekly for 8 weeks
Fecal Microbiota Metagenomic Profile (Shotgun Sequencing)
Presence of predictive microbiota signatures and evolution of gut microbiome composition.
Measured: Baseline (V0) and Week 8 (V2)
Adverse Events Reporting
Measured: Weekly until 8 week and at Week 4 (V1), Week 8 (V2)
Proportion of participants requiring initiation of antidepressant therapy
Measured: Up to Week 8 (V2)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2026
- Study start24 Mar 2026
- Primary completionNov 2027 (estimated)
- Study completionNov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DepressionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants are assigned to two parallel groups: supportive psychotherapy plus GynMDD or supportive psychotherapy plus placebo.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 168 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fondation FondaMental
- Sponsor type
- University, hospital or other
- Collaborators
- GYNOV
- Responsible party
- Sponsor
- Investigators
- Marion LEBOYER, Pr, Study chair, Fondation FondaMentalFAUCHER Pierre, Dr, Study director, GYNOV
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07416747
- Sponsor's protocol ID
- 2025-A00661-48
- Other IDs
- 2025-A00661-48
- Acronym
- SWING
- Status last verified
- Oct 2026
- First submitted
- 9 Dec 2025
- Last updated
- 7 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT07416747
- Acronym / sponsor ID
- SWING / 2025-A00661-48
- Conditions
- Depression, Depression Disorder, Depression in Adults
- Keywords
- Gut-Brain Axis, Gut Microbiota, GynMDD, Mild Depression, Moderate Depression, MADRS, Supportive Psychotherapy, Psychotherapy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 168 participants (estimated)
- Lead sponsor
- Fondation FondaMentalUniversity, hospital or other
- Collaborators
- GYNOV
- Study start
- 24 Mar 2026 (actual)
- Primary completion
- Nov 2027 (estimated)
- Study completion
- Nov 2027 (estimated)
- First posted
- 18 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Participants are assigned to two parallel groups: supportive psychotherapy plus GynMDD or supportive psychotherapy plus placebo.
| Arm | Type | Receives |
|---|---|---|
| Supportive Psychotherapy + GynMDD | Experimental | Dietary Supplement: GynMDDSupportive Psychotherapy and Dietary Supplement |
| Supportive Psychotherapy + Placebo | Placebo comparator | Other: PlaceboSupportive Psychotherapy and Placebo |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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)
Key exclusion criteria (17 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GynMDDDietary Supplement: GynMDD (Sorolys®) Daily 2.5 g stick for 8 weeks Includes L-glutamine, Cavacurmin®, and Lacticaseibacillus rhamnosus GG | Dietary supplement | Supportive Psychotherapy + GynMDD |
| PlaceboPlacebo for 8 weeks Identical stick without active ingredients; β-carotene added for color | Other | Supportive Psychotherapy + Placebo |
Primary outcome
Change in MADRS Score
Time frame: Baseline (V0) to Week 8 (V2)
Assessment of depressive symptoms using the Montgomery-Åsberg Depression Rating Scale (MADRS).
6 secondary outcomes
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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Oct 2026.
- Individual participant dataSharing planned: No
Related trials for Depression
Active, not recruiting
NYUCI-ES: Psychosocial Intervention to Improve Health Outcomes for Chinese and Korean ADRD Caregivers
Dementia Caregivers, Diabetes
Not yet recruiting
Lung Cancer and Aging: Improving Well-being for Older Adults With Lung Cancer
Lung Cancer
RecruitingPhase 1
Ketamine Pharmacokinetics and Pharmacodynamics for Postpartum Depression and Pain After Cesarean Delivery
Pain, Postpartum Depression
Recruiting
Unified Protocol in Penitentiary Facilities
Depression Disorders, Anxiety
Recruiting
Bonding Before Birth: A mHealth Intervention for First-time Expectant Couples
Anxiety, Pregnancy
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Clinical Operation Director contact
Marion LEBOYER, Pr study chair
Fondation FondaMental
FAUCHER Pierre, Dr study director
GYNOV
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing GynMDD in people with Depression and Depression Disorder, run by Fondation FondaMental at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 7 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Clinical Project Manager (+3314981326, michelle.haddad@fondation-fondamental.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in MADRS Score (time frame: Baseline (V0) to Week 8 (V2)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Oct 2026; AzTrials last refreshed its copy on 7 Nov 2026.