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Probiotic IBNI617 for Moderate to Severe Depression: A Randomized Controlled Trial

Not Yet RecruitingNA

Sponsor: IBIOME BIOTECHNOLOGY CO., LTD

Conditions: Major Depressive Disorder (MDD), IBNI617

Interventions: Live biotherapeutic product, Placebo

Countries: China

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.

Eligibility overview

Sex: ALL

Age: 18 Years to 65 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

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;
* No antidepressant medication used 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.

Locations (1)

Shanghai, China