NCT06692361

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 214 (estimated)
• Sponsor: Gang Wang · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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

Detailed description

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.

Conditions

• Major Depressive Disorder (MDD)
• Depression - Major Depressive Disorder

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2025-01-01
• Primary completion: 2026-06-01
• Completion: 2026-12-01
• First posted: 2024-11-18
• Last updated: 2025-12-02

Locations

9 sites across 1 country: China