Probiotic IBNI617 for Moderate to Severe Depression
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Live biotherapeutic product, Placebo.
- Who it may be relevant to
- Registry conditions: Major Depressive Disorder (MDD), IBNI617. Basic parameters: 18 years — 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
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
Overview
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.
Interventions
- Other Live biotherapeutic product
IBNI617 PO BID - Other Placebo
Placebo PO BID
Primary outcome measures
- 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. [Time frame: 8 weeks]
Secondary outcome measures (2)
- Change from baseline in Montgomery Asperger Depression Scale (MADRS) total score at week 8 [Time frame: 8 weeks]
- Number and percentage of participants experiencing at least one Adverse Event(AE). [Time frame: 12 weeks]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Triple blind
- Primary purpose
- Treatment
Study locations
China · 1 center
- Shanghai Mental Health Center — Shanghai
Identifiers
NCT: NCT07728253 · HW-617-02