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
Sex
ALL
Min age
18 Years
Max age
65 Years
Healthy volunteers
No
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.
Primary outcome measure(s)
To assess the efficacy of IBNI617 compared with placebo, as measured by the change from baseline in Hamilton Depression Scale (HAM-D-17) total score at Week 8. — 8 weeks The HAM-D-17 is a 17-item, clinician-rated scale that assesses depressive symptoms. Each item is rated on a scale of 0-2 or 0-4. The total score can range from 0-52. Higher HAM-D-17 scores indicate more severe depression.
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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