Probiotic IBNI617 for Moderate to Severe Depression
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorIBIOME BIOTECHNOLOGY CO., LTD
About this trial
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 criteria
Qualifiers
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.
Disqualifiers
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;
Trial design
Treatments tested in this trial
- Live biotherapeutic product
- Placebo
Treatment groups
148 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov