Probiotic IBNI617 for Moderate to Severe Depression
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
1 other identifier
interventional
148
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Aug 2026
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 22, 2026
CompletedFirst Posted
Study publicly available on registry
July 27, 2026
CompletedStudy Start
First participant enrolled
August 1, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
April 1, 2028
July 30, 2026
July 1, 2026
1.3 years
July 22, 2026
July 29, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
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.
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.
8 weeks
Secondary Outcomes (2)
Change from baseline in Montgomery Asperger Depression Scale (MADRS) total score at week 8
8 weeks
Number and percentage of participants experiencing at least one Adverse Event(AE).
12 weeks
Study Arms (2)
IBNI617
EXPERIMENTALIBNI617 BID for 8 weeks
Placebo
PLACEBO COMPARATORPlacebo BID for 8 weeks
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Shanghai Mental Health Center
Shanghai, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 22, 2026
First Posted
July 27, 2026
Study Start
August 1, 2026
Primary Completion (Estimated)
December 1, 2027
Study Completion (Estimated)
April 1, 2028
Last Updated
July 30, 2026
Record last verified: 2026-07