[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100624985":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":31,"centralContacts":39,"locations":48,"responsibleParty":64,"collaborators":66,"id":69,"slug":70,"hasResults":71,"nctId":72,"briefTitle":73,"officialTitle":74,"acronym":75,"eligibilityCriteria":76,"healthyVolunteers":71,"sex":77,"minAge":78,"maxAge":79,"enrollmentInfo":80,"targetDuration":26,"studyType":83,"phases":84,"briefSummary":86,"conditions":87,"keywords":91,"overallStatus":107,"whyStopped":26,"lastUpdateSubmitDate":108,"lastUpdatePostDateStruct":109,"startDateStruct":112,"completionDateStruct":114,"leadSponsor":116,"locationsCount":117},{"fullName":5,"class":6},"Fondation FondaMental","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Supportive Psychotherapy + GynMDD","EXPERIMENTAL","Supportive Psychotherapy and Dietary Supplement",[13],"Dietary Supplement: GynMDD",{"label":15,"type":16,"description":17,"interventionNames":18},"Supportive Psychotherapy + Placebo","PLACEBO_COMPARATOR","Supportive Psychotherapy and Placebo",[19],"Other: Placebo",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DIETARY_SUPPLEMENT","GynMDD","Dietary Supplement: GynMDD (Sorolys®) Daily 2.5 g stick for 8 weeks Includes L-glutamine, Cavacurmin®, and Lacticaseibacillus rhamnosus GG",[9],null,{"type":6,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"Placebo","Placebo for 8 weeks Identical stick without active ingredients; β-carotene added for color",[15],[32,35],{"name":33,"affiliation":5,"role":34},"Marion LEBOYER, Pr","STUDY_CHAIR",{"name":36,"affiliation":37,"role":38},"FAUCHER Pierre, Dr","GYNOV","STUDY_DIRECTOR",[40,45],{"name":41,"role":42,"phone":43,"phoneExt":26,"email":44},"Clinical Project Manager","CONTACT","+3314981326","laina.ndiaye@fondation-fondamental.org",{"name":46,"role":42,"phone":26,"phoneExt":26,"email":47},"Clinical Operation Lead","imene.benmohamed@fondation-fondamental.org",[49],{"facility":50,"status":26,"city":51,"state":26,"zip":52,"country":53,"countryCode":54,"cosmosGeoPoint":55,"geoPoint":60,"contacts":61},"Hôpital Albert Chenevier 40 rue de Mesly","Créteil","94010","France","FR",{"type":56,"coordinates":57},"Point",[58,59],2.46569,48.79266,{"lat":59,"lon":58},[62],{"name":26,"role":42,"phone":26,"phoneExt":26,"email":63},"swing@fondation-fondamental.org",{"type":65,"investigatorFullName":26,"investigatorTitle":26,"investigatorAffiliation":26,"oldNameTitle":26,"oldOrganization":26},"SPONSOR",[67],{"name":37,"class":68},"INDUSTRY","100624985","gynmdd-add-on-to-supportive-psychotherapy-in-mild-to-moderate-depression-100624985",false,"NCT07416747","GynMDD Add-On to Supportive Psychotherapy in Mild to Moderate Depression","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.","SWING","Inclusion Criteria:\n\n* Adults aged 18 to 65 years, inclusive\n* The main reason for consultation is a suspected depressive episode\n* MADRS score between 15 and 34, indicating mild to moderate depression\n* No suicidal risk, defined as a score of 0 on item 10 of the MADRS scale\n* Body Mass Index (BMI) between 19 and 29 (inclusive)\n* 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)\n* Affiliation with the French national health insurance system or beneficiary of such coverage\n\nExclusion Criteria:\n\n* History of severe psychiatric disorders or currently undergoing supportive psychotherapy\n* Confirmed suicidal risk, defined as a score between 1 and 6 on MADRS item 10\n* Current treatment with antidepressants (AD)\n* MADRS score \\> 34\n* Conditions in which probiotic administration is not recommended (e.g., immunodeficiency, presence of a venous catheter)\n* Allergy to any component of the placebo or the GynMDD dietary supplement\n* Current consumption of probiotic-based dietary supplements\n* Recent infectious episodes that may require antibiotic therapy\n* Current treatment with anxiolytics\n* Long-term chronic anti-inflammatory treatment\n* Alcohol abuse, defined as a consumption of 10 standard drinks per week or more\n* Use of illicit drugs or substances of abuse\n* Inability to provide informed consent\n* Participation in another clinical study within the past 12 months\n* Pregnant or breastfeeding women\n* Patients without health insurance\n* Individuals under legal protection, guardianship, trusteeship, or any other protective measure","ALL","18 Years","65 Years",{"count":81,"type":82},168,"ESTIMATED","INTERVENTIONAL",[85],"NA","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:\n\nDoes adding GynMDD to supportive psychotherapy lead to a greater reduction in depressive symptoms (measured by the MADRS scale) compared with supportive psychotherapy plus placebo?\n\nDoes the supplement also improve digestive well-being and influence gut microbiota profiles over the course of treatment?\n\nResearchers will compare patients receiving supportive psychotherapy + GynMDD to those receiving supportive psychotherapy + placebo to see if GynMDD provides additional benefits beyond standard care.\n\nParticipants will:\n\n* Attend regular appointments with their general practitioner\n* Complete one supportive psychotherapy session per week for 8 weeks\n* Take a daily dose of GynMDD or placebo\n* Complete weekly self-assessment questionnaires on mood, digestive symptoms, and any side effects via a mobile app\n* Provide two stool samples (at the start and end of the study) for microbiota analysis",[88,89,90],"Depression","Depression Disorder","Depression in Adults",[92,93,23,94,95,96,97,98,99,100,101,102,103,104,105,106],"Gut-Brain Axis","Gut Microbiota","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","NOT_YET_RECRUITING","2026-02-13",{"date":110,"type":111},"2026-02-18","ACTUAL",{"date":113,"type":82},"2026-03",{"date":115,"type":82},"2027-11",{"name":5,"class":6},1]