Actively Recruiting
Assessment of the Efficacy and Safety of Fecal Microbiota Transplantation (FMT) in Patients With Major Depressive Disorder
Led by Gang Wang · Updated on 2025-12-02
214
Participants Needed
9
Research Sites
99 weeks
Total Duration
On this page
Sponsors
G
Gang Wang
Lead Sponsor
S
Shandong Daizhuang Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
CONDITIONS
Official Title
Assessment of the Efficacy and Safety of Fecal Microbiota Transplantation (FMT) in Patients With Major Depressive Disorder
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Outpatient or inpatient aged 18 to 65 years, any gender
- Diagnosed with recurrent or single-episode major depressive disorder (MDD) according to DSM-5 criteria at screening
- Hamilton Depression Rating Scale (HAMD-17) score of 17 or higher at screening
- No medication treatment for the current depressive episode before screening
- Planned to be treated with escitalopram as a single antidepressant
- Less than 20% reduction in HAMD-17 score after 2 weeks of maximum tolerated escitalopram treatment compared to screening
- Education level above primary school and able to understand scale content
- Signed informed consent form
You will not qualify if you...
- Current or past diagnosis of bipolar disorder, neurodevelopmental disorder, neurocognitive disorder, schizophrenia spectrum or other psychotic disorders, substance-related or addiction disorders
- Presence of significant psychotic symptoms such as delusions or hallucinations
- Severe or unstable diseases of the central nervous, cardiovascular, respiratory, liver, kidney, endocrine, blood systems, or others making participation unsuitable
- Serious suicide risk with HAMD-17 suicide risk item score of 3 or higher
- Inflammatory diseases
- Gastrointestinal infections, tumors, or structural digestive system abnormalities including irritable bowel syndrome, Crohn's disease, ulcerative colitis, celiac disease
- History of gastrointestinal surgery
- Use of antibiotics, probiotics, prebiotics, or traditional Chinese medicine for medical purposes continuously for more than 2 weeks within 3 months before enrollment
- Allergy to capsule ingredients
- Pregnant or breastfeeding
- Unable or unwilling to swallow capsules
- Received modified electroconvulsive therapy (MECT) in the past 6 months
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 9 locations
1
Wuhu Fourth People's Hospital
Wuhu, Anhui, China, 241002
Actively Recruiting
2
Beijing Anding Hospital
Beijing, Beijing Municipality, China, 100088
Actively Recruiting
3
Nangfang Hospital Affiliated of Southern Medical University
Guangzhou, Guangdong, China, 510450
Not Yet Recruiting
4
The First Affiliated Hospital of Hebei Medical University
Shijiazhuang, Hebei, China, 050000
Actively Recruiting
5
Shandong Daizhuang Hospital
Jining, Shandong, China, 272000
Actively Recruiting
6
West China Hospital Affiliated of Sichuan University
Chengdu, Sichuan, China, 610041
Actively Recruiting
7
Tianjin Anding Hospital
Tianjin, Tianjin Municipality, China, 300202
Actively Recruiting
8
The Second People's Hospital of Dali Bai Autonomous Prefecture
Dali, Yunnan, China, 671003
Actively Recruiting
9
The First Affiliated Hospital of Zhejiang University
Hangzhou, Zhejiang, China, 310000
Actively Recruiting
Research Team
G
Gang Wang
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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