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
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 148
- 试验地点
- 1
- 主要终点
- 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.
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Placebo
Placebo BID for 8 weeks
干预措施: Placebo (Other)
IBNI617
IBNI617 BID for 8 weeks
干预措施: Live biotherapeutic product (Other)
结局指标
主要结局
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.
时间窗: 8 weeks
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.
时间窗: 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.
次要结局
- Number and percentage of participants experiencing at least one Adverse Event(AE).(12 weeks)
- Change from baseline in Montgomery Asperger Depression Scale (MADRS) total score at week 8(8 weeks)