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RECRUITING
NCT06692361
NA

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

Sponsor: Gang Wang

View on ClinicalTrials.gov

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

Official title: 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

Key Details

Gender

All

Age Range

18 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

214

Start Date

2025-01-01

Completion Date

2026-12

Last Updated

2025-12-02

Healthy Volunteers

No

Interventions

BIOLOGICAL

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.

DRUG

Escitalopram (Lexapro)

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

BIOLOGICAL

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.

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