🇮🇪Ireland
16°C Partly Cloudy · Dublin
Live Updates
--:--:-- IST
Writer Login
Latest
Clinical Trials in China / NCT06692361
Recruiting Not applicable

Assessment of the Efficacy and Safety of Fecal Microbiota Transplantation (FMT) in Patients With Major Depressive Disorder

NCT06692361 · tracked via the Priya Life Science China tracker
Sponsor
Gang Wang
Phase
Not applicable
Started
2025-01-01
Last updated
2025-12-02

Condition(s) studied

Major Depressive Disorder (MDD)Depression - Major Depressive Disorder

Investigational drug(s) / intervention(s)

FMT capsuleEscitalopram (Lexapro)Corn Starch capsules

FMT capsule: The experimental group will maintain escitalopram treatment and take 1.0 g of FMT capsules orally with breakfast every day for 4 weeks.

Escitalopram (Lexapro): Both the experimental group and the placebo group were treated with the maximum tolerated dose of escitalopram.

Corn Starch capsules: The placebo group will maintain escitalopram treatment and take corn starch capsules 1.0 g orally with breakfast every day for 4 weeks.

Study summary

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

Eligibility

Sex
ALL
Min age
18 Years
Max age
65 Years
Healthy volunteers
No
Inclusion Criteria (All 8 criterion are met): * Outpatient or inpatient, aged 18 to 65 years (inclusive), regardless of gender; * At the start of the screening phase, participants must meet the Diagnostic and Statistical Manual of Mental Disorders-fifth edition (DSM-5) diagnostic criteria for recurrent major depressive disorder (MDD) or single-episode MDD; * At the start of the screening phase, participants' score on the 17-item Hamilton Depression Rating Scale (HAMD-17) must be ≥ 17; * At the start of the screening phase, participants have not been treated with medication for their current depressive episode; * At the start of the screening phase, participants are intended to be treated with a single antidepressant medication, Escitalopram; * The HAMD-17 score after two weeks of treatment with the maximum tolerated dose of escitalopram was reduced by less than 20% compared with the HAMD-17 score at screening; * Participants must have an education level above primary school and be able to understand the content of the scale; * Participants sign the informed consent form. Exclusion Criteria (Exclude if 1 criterion is met): * According to DSM-5 criteria, currently or previously diagnosed as bipolar disorder, neurodevelopmental disorder, neurocognitive disorder, schizophrenia spectrum and other psychotic disorders, substance-related and addiction disorders; * Accompanied by significant psychotic symptoms (delusions, hallucinations, etc.); * The patient currently has severe or unstable central nervous system, cardiovascular, respiratory, liver, kidney, endocrine, blood system or other system diseases, and the researcher believes that the patient is not suitable for inclusion in this study; * The patient currently has a serious suicide risk, and the HAMD-17 suicide risk item is ≥3 points; * Suffering from inflammation-related diseases; * Suffering from gastrointestinal infections, tumors and other structural abnormalities of the digestive system, including but not limited to irritable bowel syndrome, Crohn's disease, ulcerative colitis, celiac disease, etc.; * Previous history of gastrointestinal surgery; * Continuous use of antibiotics, probiotics, prebiotics or traditional Chinese medicine products for medical purposes for more than 2 weeks within 3 months before enrollment in the study; * Those who are allergic to capsule ingredients and contents; * Pregnant or lactating patients; * Patients who are unable (such as difficulty swallowing) or unwilling to swallow capsules; * Patients who received MECT treatment in the past 6 months.

Primary outcome measure(s)

Trial sites (9)

FacilityCityRegionStatus
Wuhu Fourth People's Hospital Wuhu Anhui Recruiting
Beijing Anding Hospital Beijing Beijing Municipality Recruiting
Nangfang Hospital Affiliated of Southern Medical University Guangzhou Guangdong Not Yet Recruiting
The First Affiliated Hospital of Hebei Medical University Shijiazhuang Hebei Recruiting
Shandong Daizhuang Hospital Jining Shandong Recruiting
West China Hospital Affiliated of Sichuan University Chengdu Sichuan Recruiting
Tianjin Anding Hospital Tianjin Tianjin Municipality Recruiting
The Second People's Hospital of Dali Bai Autonomous Prefecture Dali Yunnan Recruiting
The First Affiliated Hospital of Zhejiang University Hangzhou Zhejiang Recruiting

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06692361 on ClinicalTrials.gov ↗ ← All trials in China