Microbiotherapy in Characterized Depressive Disorder

NCT05280015 | Unknown Phase 2

• 1 other identifier: 2021/621
• Study Type: interventional
• Target: 92
• Locations: 1 country
• Sites: 4

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-on with a 2nd antidepressant, venlafaxine.

Conditions

Depression; Depressive Disorder; Depressive Disorder, Major

Keywords

depression; microbiotherapy

Outcome Measures

Primary Outcomes (1)

• Change from Baseline Quick Inventory of Depressive Symptomatology (QIDS-C16) at 12 weeks

  The QIDS-C16 is a 16-item scale that is clinician-rated; it is designed to assess the severity of depressive symptoms. The QIDS-C16 total score ranges from 0-27. Scores ranging from 0 to 10 correspond with no to mild depression, while scores \>/= 11 correspond to moderate to severe depression. A negative change indicates improvement in the subject's depression, and a positive change indicates a worsening of the subject's depression.

  baseline (Day 0), Week 12 (W12) post-treatment

Secondary Outcomes (9)

• Change from Severity of depressive symptoms evaluated by the clinician

  baseline (Day 0), at the end of therapy (week 12 (W12)

• Change from Severity of depressive symptoms evaluated by the patient

  baseline (Day 0), at the end of therapy (week 12 (W12)

• Evaluation of treatment observance

  baseline (Day 0), at the end of therapy (week 12 (W12)

• Change from Health related Quality of Life (HrQoL)

  baseline (Day 0), at the end of therapy (week 12 (W12)

• Change from anxiety

  baseline (Day 0), at the end ot therapy (week 12 (W12)

Study Arms (2)

Microbiotherapy in addition of venlafaxin

ACTIVE COMPARATOR

Subjects suffering of MDD and treated by venlafaxine in a second-line assigned to start the microbiotherapy during 12 weeks. The microbiotherapy is GynMDD devlopped by Gynov and which is composed by a probiotic associated to polyphenol and an amino acid.

Dietary Supplement: microbiotherapy (GynMDD)

calibration arm

PLACEBO COMPARATOR

Subjects suffering of MDD and treated by venlafaxine in a second-line assigned to start the placebo therapy during 12 weeks.

Other: placebo

Interventions

microbiotherapy (GynMDD) DIETARY_SUPPLEMENT

multi-target microbiotherapy add-on venlafaxine

Microbiotherapy in addition of venlafaxin

placebo OTHER

placebo add-on venlafaxine

calibration arm

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Besancon: lead
• Fondation FondaMental: collaborator
• GYNOV: collaborator

Study Sites (4)

Emmanuel HAFFEN

Besançon, 25030, France

RECRUITING

Centre Hospitalier Spécialisé Charles Perrens

Bordeaux, 33000, France

NOT YET RECRUITING

CHU de Clermont-Ferrand

Clermont-Ferrand, 63000, France

NOT YET RECRUITING

Hôpital Henri Mondor / APHP

Créteil, 94000, France

RECRUITING

MeSH Terms

Conditions

Depression; Depressive Disorder; Depressive Disorder, Major

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Mood Disorders; Mental Disorders

Study Officials

• Emmanuel HAFFEN, MD PhD

  CHU de Besançon

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Emmanuel HAFFEN, PhD

CONTACT

0033 3 81 21 90 07; emmanuel.haffen@univ-fcomte.fr

Magali NICOLIER, PhD

CONTACT

0033 3 81 21 90 07; mnicolier@chu-besancon.fr

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: After randomization, subjects suffering of MDD and treated by venlafaxine in a second-line assigned to start the microbiotherapy pr placebo during 12 weeks. The microbiotherapy is GynMDD developped by Gynov and which is composed by a probiotic associated to polyphenol and an amino acid.

Study Record Dates

• First Submitted: February 18, 2022
• First Posted: March 15, 2022
• Study Start: June 8, 2022
• Primary Completion: July 1, 2024
• Study Completion: December 1, 2024
• Last Updated: September 9, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

FR (4)