Assessment of the Effectiveness and Safety of Fecal Microbiota Transplantation (FMT) in Patients With Major Depressive Disorder Who Do Not Show Early Improvement Following Antidepressant Treatment: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 214
- 试验地点
- 9
- 主要终点
- The differences in efficacy(HAMD-17 score reduction rate ≥50%) between the two groups
研究概览
简要总结
This study aimed to evaluate the efficacy and safety of fecal microbiota transplantation (FMT) in patients with major depressive disorder (MDD) who exhibit suboptimal early response to antidepressant treatment. Additionally, it sought to investigate the impact of FMT on biological indicators, including intestinal microbiota and metabolites, in individuals with MDD
详细描述
This multicenter, randomized, double-blind, placebo-controlled study aims to compare the efficacy and safety of adjunctive FMT in patients with major depressive disorder (MDD) who show limited response to initial drug therapy.
A total of 600 patients experiencing depressive episodes will be screened, with all receiving escitalopram oxalate for an initial 2-week period. Of these, 214 participants who exhibit suboptimal therapeutic response to early antidepressant treatment will be enrolled and randomized in a 1:1 ratio to either the experimental group or control group.
During the intervention, participants will continue their existing antidepressant regimen and receive a 4-week treatment with either microbiota capsules or placebo. An additional 20-week follow-up assessment will then be conducted to evaluate outcomes.
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, Investigator, Outcomes Assessor)
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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Escitalopram + FMT
The experimental group will receive escitalopram + FMT capsules (using Oral capsules derived from healthy human fecal microbiota)
干预措施: FMT capsule (Biological)
Escitalopram + FMT
The experimental group will receive escitalopram + FMT capsules (using Oral capsules derived from healthy human fecal microbiota)
干预措施: Escitalopram (Lexapro) (Drug)
Escitalopram + placebo
The control group will be treated with escitalopram + placebo (using capsules containing only corn starch)
干预措施: Escitalopram (Lexapro) (Drug)
Escitalopram + placebo
The control group will be treated with escitalopram + placebo (using capsules containing only corn starch)
干预措施: Corn Starch capsules (Biological)
结局指标
主要结局
The differences in efficacy(HAMD-17 score reduction rate ≥50%) between the two groups
时间窗: Baseline, Week 4, Week 8
The Hamilton Depression Rating Scale-17(HAMD-17) was used to assess the severity of depression in patients. If the HAMD-17 score reduction rate was ≥50%, the treatment was considered effective. 4 weeks after 4-week treatments, the differences in the effective rate of treatment between the two groups will be compared.
次要结局
- The differences in complete remission rate(HAMD-17 ≤ 7 points) between the two groups(Baseline and Week 4)
- The differences in effective rate(HAMD-17 score reduction rate ≥50%)(Baseline and Week 4)
- Changes in total score of GAD-7 scale(Baseline, Week 4, Week 8, Week 12, Week 24)
- Changes in total score of QIDS-SR scale(Baseline, Week 4, Week 8, Week 12, Week 24)
- The differences in the reduction scores of the HAMD-17 scale in 4 symptom dimensions(Baseline, Week 4, Week 8, Week 12, Week 24)
- Changes in total score of GSRS scale(Baseline, Week 4, Week 8, Week 12, Week 24)
- Changes in total score of SF-12 scale(Baseline, Week 4, Week 8, Week 12, Week 24)
- Changes in total score of SDS scale(Baseline, Week 4, Week 8, Week 12, Week 24)
- Changes in total score of PDQ-5D scale(Baseline, Week 4, Week 8, Week 12, Week 24)
- Changes of each subscale of CBCT(Baseline, Week 4, Week 8, Week 12, Week 24)
- Changes of each subscale of CGI(Baseline, Week 4, Week 8, Week 12, Week 24)
- Changes of each subscale of PSQI(Baseline, Week 4, Week 8, Week 12, Week 24)
- Changes in brain imaging and EEG indicators(Baseline, Week 4, Week 8, Week 12, Week 24)
- Evaluation of the safety of the treatments(Baseline, Week 4, Week 8, Week 12, Week 24)
研究者
Gang Wang
Director of Beijing Anding Hospital
Capital Medical University