Clinical Research Directory

Probiotic IBNI617 for Moderate to Severe Depression

Sponsor: IBIOME BIOTECHNOLOGY CO., LTD

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.

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

Key Details

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Interventions

Locations (1)