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Microbiotherapy in Characterized Depressive Disorder

NCT05280015 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 92

Last updated 2022-09-09

No results posted yet for this study

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.

Conditions

  • Depression
  • Depressive Disorder
  • Depressive Disorder, Major

Interventions

DIETARY_SUPPLEMENT

microbiotherapy (GynMDD)

multi-target microbiotherapy add-on venlafaxine

OTHER

placebo

placebo add-on venlafaxine

Sponsors & Collaborators

  • Fondation FondaMental

    collaborator OTHER

  • GYNOV

    collaborator INDUSTRY

  • Centre Hospitalier Universitaire de Besancon

    lead OTHER

Principal Investigators

  • Emmanuel HAFFEN, MD PhD · CHU de Besançon

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-06-08
Primary Completion
2024-07-31
Completion
2024-12-31

Countries

  • France

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05280015 on ClinicalTrials.gov