GynMDD Add-On to Supportive Psychotherapy in Mild to Moderate Depression
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorFondation FondaMental
About this trial
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
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
GynMDD
Dietary supplementDietary Supplement: GynMDD (Sorolys®) Daily 2.5 g stick for 8 weeks Includes L-glutamine, Cavacurmin®, and Lacticaseibacillus rhamnosus GG
Placebo
Other interventionPlacebo for 8 weeks Identical stick without active ingredients; β-carotene added for color
Treatment groups
168 Participants
are divided into 2 treatment groupsGroup A: Supportive Psychotherapy + GynMDDExperimental treatment 1 intervention
Group B: Supportive Psychotherapy + PlaceboPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Change in MADRS Score
Assessment of depressive symptoms using the Montgomery-Åsberg Depression Rating Scale (MADRS).
Time frame
Baseline (V0) to Week 8 (V2)Secondary outcomes
1
Change in Digestive Symptom Score (WGO scale)
Difference in scores on the World Gastroenterology Organization digestive health scale between baseline and follow-up visits.
Time frame
Baseline (V0), Week 4 (V1), Week 8 (V2)2
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.
Time frame
Weekly for 8 weeks3
Change in GSRS-IBS Digestive Symptom Score
Weekly GSRS-IBS digestive symptom scores completed on the digital platform.
Time frame
Weekly for 8 weeks4
Fecal Microbiota Metagenomic Profile (Shotgun Sequencing)
Presence of predictive microbiota signatures and evolution of gut microbiome composition.
Time frame
Baseline (V0) and Week 8 (V2)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Fondation FondaMental
Lead sponsor
GYNOV
Collaborator
Source ClinicalTrials.gov