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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
148
IBNI617 PO BID
Placebo PO BID
Shanghai Mental Health Center
Shanghai, China
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.
Time frame: 8 weeks
Change from baseline in Montgomery Asperger Depression Scale (MADRS) total score at week 8
The MADRS is a 10-item, clinician-rated scale that assesses depressive symptoms. Each item is rated on a scale of 0-6. The total score can range from 0-60. Higher MADRS scores indicate more severe depression.
Time frame: 8 weeks
Number and percentage of participants experiencing at least one Adverse Event(AE).
Time frame: 12 weeks
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