Status:
UNKNOWN
Microbiotherapy in Characterized Depressive Disorder
Lead Sponsor:
Centre Hospitalier Universitaire de Besancon
Collaborating Sponsors:
Fondation FondaMental
GYNOV
Conditions:
Depression
Depressive Disorder
Eligibility:
All Genders
20-65 years
Phase:
PHASE2
Brief 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...
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 patho...
Eligibility Criteria
Inclusion
- Diagnosis of unipolar MDD (Diagnostic and Statistical Manual of Mental Disorders V \[DSM-V\], QIDS-C16≥15)
- No response at a first antidepressant
- under venlafaxine
- Signed informed consent form
- Subjects affiliated to or beneficiary from a French social security regime
Exclusion
- Contraindications to probiotic administration
- Allergy to one of the compounds of the multi-target probiotic or the placebo
- consuming probiotic-based dietary supplements
- Patient with other psychiatric disorders, except social anxiety disorder, generalized anxiety disorder and nicotine use disorder
- Patient with a serious and/or progressive medical condition, including chronic inflammatory pathologies or autoimmune diseases requiring long-term anti-inflammatory treatment (including corticosteroid therapy) or immunosuppressant.
- Patient with a recent infectious episode likely to require antibiotic therapy.
- Patient presenting with a suicidal risk assessed by the suicide item of the QIDS-C16 scale (score item 12 of the QIDS-C16 \>2)
- Other concomitant antidepressant and/or lithium and/or anti-inflammatory treatment for the duration of the study
- Subject under measure of protection or guardianship of justice
- Subject beneficiary from a legal protection regime
- Subject unlikely to cooperate or low cooperation stated by investigator
- Subject not covered by social security
- Pregnant woman
- Subject being in the exclusion period of another study or provided for by the "National Volunteer File
Key Trial Info
Start Date :
June 8 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2024
Estimated Enrollment :
92 Patients enrolled
Trial Details
Trial ID
NCT05280015
Start Date
June 8 2022
End Date
December 1 2024
Last Update
September 9 2022
Active Locations (4)
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1
Emmanuel HAFFEN
Besançon, France, 25030
2
Centre Hospitalier Spécialisé Charles Perrens
Bordeaux, France, 33000
3
CHU de Clermont-Ferrand
Clermont-Ferrand, France, 63000
4
Hôpital Henri Mondor / APHP
Créteil, France, 94000