GynMDD Add-On to Supportive Psychotherapy in Mild to Mode... | NCT07416747

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

NCT07416747

Sponsor

Fondation FondaMental

Status

Not yet recruiting

Last Update Posted

Feb 18, 2026Actual

Enrollment

168Estimated

Phase

Not Applicable

Conditions

Depression
Depression Disorder
Depression in Adults

Interventions

GynMDD
Placebo

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
2025-A00661-48	Other Identifier	IDRCB

Status Module

Record Verification Date

Feb 2025

Overall Recruitment Status or Expanded Access Status

Not yet recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2026Estimated

Primary Completion Date

Nov 2027Estimated

Completion Date

Nov 2027Estimated

First Submitted Date

Dec 9, 2025

First Submission Date that Met QC Criteria

Feb 13, 2026

First Posted Date

Feb 18, 2026Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 13, 2026

Last Update Posted Date

Feb 18, 2026Actual

Name	Class
GYNOV	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

168Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Supportive Psychotherapy + GynMDD	Experimental	Supportive Psychotherapy and Dietary Supplement	Dietary Supplement: GynMDD
Supportive Psychotherapy + Placebo	Placebo Comparator	Supportive Psychotherapy and Placebo	Other: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
GynMDD	Dietary Supplement	Dietary Supplement: GynMDD (Sorolys®) Daily 2.5 g stick for 8 weeks Includes L-glutamine, Cavacurmin®, and Lacticaseibacillus rhamnosus GG	Supportive Psychotherapy + GynMDD

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change in MADRS Score	Assessment of depressive symptoms using the Montgomery-Åsberg Depression Rating Scale (MADRS).	Baseline (V0) to Week 8 (V2)

Secondary Outcomes

Measure	Description	Time Frame
Change in Digestive Symptom Score (WGO scale)	Difference in scores on the World Gastroenterology Organization digestive health scale between baseline and follow-up visits.	Baseline (V0), Week 4 (V1), Week 8 (V2)
Change in PHQ-9 Self-Reported Depression Score

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Clinical Project Manager	Contact	+3314981326		laina.ndiaye@fondation-fondamental.org
Clinical Operation Lead	Contact			imene.benmohamed@fondation-fondamental.org

Overall Officials

Name	Affiliation	Role
Marion LEBOYER, Pr	Fondation FondaMental	Study Chair
FAUCHER Pierre, Dr	GYNOV	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hôpital Albert Chenevier 40 rue de Mesly		Créteil		94010	France

ID	Term
D003863	Depression
D000092862	Psychological Well-Being

ID	Term
D001526	Behavioral Symptoms
D001519	Behavior
D010549	Personal Satisfaction