NCT05280015

Microbiotherapy in Characterized Depressive Disorder

A Phase II, Prospective, Multicenter Study Assessing the Contribution and Tolerance of a Multi-targeted Microbiotherapy in Addition to Venlafaxine, After Failure of a First-line Antidepressant Treatment in Depressed Patients

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 92 (estimated)
• Sponsor: Centre Hospitalier Universitaire de Besancon · Academic / Other
• Sex: All
• Age: 20 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The study aims to evaluate the contribution of a multi-targeted microbiotherapy at 12 weeks in depressed-patients in a situation of failure of a 1st line of antidepressant treatment and treated in add-on with a 2nd antidepressant, venlafaxine.

Detailed description

Depression is the most common psychiatric illness and has major personal, societal and economic consequences. Increase in the disease prevalence is significantly associated with certain somatic pathologies, including metabolic diseases and functional intestinal disorders. From a therapeutic point of view, approximately 2/3 patients are not in remission after first-line antidepressant treatment. Moreover, 20 to 30% patients resist at all the therapeutic strategies classically proposed in this indication. The identification of new therapeutic strategies is therefore a major challenge, especially for patients with chronic depression resistant to standard treatments. Various research studies have shown the involvement of inflammatory mechanisms in depression. Thus, the increase in the disease prevalence is significantly associated with certain somatic pathologies, in particular metabolic diseases, a certain number of which are linked to abnormalities of the intestinal microbiota. In this context, the use of probiotics is interesting because some have antidepressant effects, anti-inflammatory and metabolic properties. However, even if a few studies have shown an antidepressant effect of probiotics with improvement of biological markers of inflammation, it seems that the use of probiotics alone is not sufficient for lasting results on depressive symptoms. The PROMOOD clinical research project fits into this context. We propose to carry out a multicenter clinical study with the product developed by GYNOV (GynMDD® multitarget compound with 3 active ingredients: an amino acid (L-glutamine), an ingredient purified from a plant extract (Cavacurmine) and a probiotic (Lactobacillus rhamnosus GG). In a preclinical study carried out at the CNRS on 144 mice, a synergy of action between these 3 ingredients was demonstrated on the anxio-depressive systems, resulting in an improvement far greater than the expected effect of composition and comparable to a reference injectable antidepressant (clomipramine). In theses context, the microbiotherapy proposed in this project is very original because: * a multi-target approach targeting several mechanisms of action: intestinal permeability, glutamine/glutamate/GABA cycle, insulin resistance, immunomodulation, oxidative stress; * prospect of an optimization/simplification of care; * It is very acceptable for patients both from the point of view of tolerance and from the economic point of view. With a phase II, prospective, multicenter design, this study aims to evaluate the contribution and the tolerance of a multi-targeted microbiotherapy in addition to venlafaxine, in a second-line antidepressant treatment. The treatment will be delivered during 12 weeks. Baseline measures will be compared to those obtained during the treatement administration (every week) and after the treatment administration (every week for the next 12 weeks).

Conditions

• Depression
• Depressive Disorder
• Depressive Disorder, Major

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	microbiotherapy (GynMDD)	multi-target microbiotherapy add-on venlafaxine
OTHER	placebo	placebo add-on venlafaxine

Timeline

• Start date: 2022-06-08
• Primary completion: 2024-07-01
• Completion: 2024-12-01
• First posted: 2022-03-15
• Last updated: 2022-09-09

Locations

4 sites across 1 country: France