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NCT07728253

Overview

NCT ID: NCT07728253
Lead Sponsor: IBIOME BIOTECHNOLOGY CO., LTDINDUSTRY
Official Title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Clinical Trial on the Efficacy and Safety of Probiotic IBNI617 Enteric-Coated Capsules in Patients With Moderate to Severe Depression
Brief Summary: IBNI617 is a live biotherapeutic product(LBP). This is a randomized, double-blind, placebo-controlled, parallel-group Phase II clinical trial to evaluate the efficacy and safety of IBNI617 in adult patients with major depressive disorder (MDD).

Eligible participants will be randomized in a 1:1 ratio to receive either IBNI617 or matched placebo twice daily for 8 weeks.

The primary objective is to assess the efficacy of IBNI617 compared with placebo, as measured by the change from baseline in HAM-D-17 total score at Week 8.
Conditions: Major Depressive Disorder (MDD)
IBNI617

Ages Eligible for Study: Adult (18-64)Older Adult (65+)
Sexes Eligible for Study: All
Accepts Healthy Volunteers?: No
Eligibility Criteria: Inclusion Criteria:

Meets DSM-5 criteria for a single episode or recurrent episode;

HAM-D-17 ≥ 22, total score of HAM-D-17 items 4, 5, and 6 ≥ 3;

MADRS ≥ 20, CGI-S ≥ 4;

Absence of antidepressant medication use or discontinuation of antidepressant medication prior to screening.

Exclusion Criteria:

Treatment-resistant depression;

Suicide attempt or suicide behavior within the past 6 months;

Used antibiotics within the past 2 weeks;

Currently use insomnia medication, excluding non-benzodiazepine drugs taken consistently for 4 weeks;

With medical history or surgical history that may affect probiotic colonization.