IBNI617, Major Depressive Disorder (MDD)
Conditions
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.
Interventions
OTHERLive biotherapeutic product
IBNI617 PO BID
OTHERPlacebo
Placebo PO BID
Sponsors
IBIOME BIOTECHNOLOGY CO., LTD
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline in Montgomery Asperger Depression Scale (MADRS) total score at week 8 | 8 weeks | 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. |
| Number and percentage of participants experiencing at least one Adverse Event(AE). | 12 weeks | — |
Countries
China
Contacts
CONTACTHuafang LI
CONTACTShen HE
Outcome results
None listed