RecruitingNot ApplicableNCT06692361

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

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


Sponsor

Gang Wang

Enrollment

214 participants

Start Date

Jan 1, 2025

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 YearsMax Age: 65 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether fecal microbiota transplantation (FMT) — a procedure that transfers healthy gut bacteria from a donor into a patient's gut — can help people with major depression who haven't responded to standard antidepressant medication. Researchers believe gut health may play a role in mental health. **You may be eligible if...** - You are between 18 and 65 years old - You have been diagnosed with major depressive disorder (a single or recurring episode) according to standard psychiatric criteria - Your depression symptoms are moderate to severe (high score on the Hamilton Depression Rating Scale) - You are not currently on depression medication for your current episode - You are willing to start treatment with escitalopram (an antidepressant) - Your symptoms did not improve enough after 2 weeks of escitalopram at the maximum tolerated dose - You have at least a primary school education level **You may NOT be eligible if...** - You have been diagnosed with bipolar disorder, schizophrenia, or a substance use disorder - You have prominent psychotic symptoms such as hallucinations or delusions - You are pregnant, breastfeeding, or have serious suicidal thoughts Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALFMT capsule

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

DRUGEscitalopram (Lexapro)

Both the experimental group and the placebo group were treated with the maximum tolerated dose of escitalopram.

BIOLOGICALCorn 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.


Locations(9)

Wuhu Fourth People's Hospital

Wuhu, Anhui, China

Beijing Anding Hospital

Beijing, Beijing Municipality, China

Nangfang Hospital Affiliated of Southern Medical University

Guangzhou, Guangdong, China

The First Affiliated Hospital of Hebei Medical University

Shijiazhuang, Hebei, China

Shandong Daizhuang Hospital

Jining, Shandong, China

West China Hospital Affiliated of Sichuan University

Chengdu, Sichuan, China

Tianjin Anding Hospital

Tianjin, Tianjin Municipality, China

The Second People's Hospital of Dali Bai Autonomous Prefecture

Dali, Yunnan, China

The First Affiliated Hospital of Zhejiang University

Hangzhou, Zhejiang, China

View Full Details on ClinicalTrials.gov

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NCT06692361


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