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

NCT06692361 | Recruiting DMC

• 1 other identifier: No. 2024-58
• Study Type: interventional
• Target: 214
• Locations: 1 country
• Sites: 9

Brief 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

Conditions

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

Keywords

faecal microbiota transplantation; microbiome; major depressive disorder; RCT

Outcome Measures

Primary Outcomes (1)

• The differences in efficacy(HAMD-17 score reduction rate ≥50%) between the two groups

  The Hamilton Depression Rating Scale-17(HAMD-17) was used to assess the severity of depression in patients. If the HAMD-17 score reduction rate was ≥50%, the treatment was considered effective. 4 weeks after 4-week treatments, the differences in the effective rate of treatment between the two groups will be compared.

  Baseline, Week 4, Week 8

Secondary Outcomes (15)

• The differences in complete remission rate(HAMD-17 ≤ 7 points) between the two groups

  Baseline, Week 4, Week 8

• The differences in effective rate(HAMD-17 score reduction rate ≥50%)

  Baseline and Week 4

• The differences in complete remission rate(HAMD-17 ≤ 7 points) between the two groups

  Baseline and Week 4

• Changes in total score of GAD-7 scale

  Baseline, Week 4, Week 8, Week 12, Week 24

• Changes in total score of QIDS-SR scale

  Baseline, Week 4, Week 8, Week 12, Week 24

Other Outcomes (1)

• Explore changes in intestinal microbiota and metabolomics indicators related to FMT efficacy

  Baseline, Week 4, Week 8, Week 12, Week 24

Study Arms (2)

Escitalopram + FMT

EXPERIMENTAL

The experimental group will receive escitalopram + FMT capsules (using Oral capsules derived from healthy human fecal microbiota)

Biological: FMT capsule; Drug: Escitalopram (Lexapro)

Escitalopram + placebo

PLACEBO COMPARATOR

The control group will be treated with escitalopram + placebo (using capsules containing only corn starch)

Drug: Escitalopram (Lexapro); Biological: Corn Starch capsules

Interventions

FMT capsule BIOLOGICAL

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

Also known as: microbiota capsule, FMT

Escitalopram + FMT

Escitalopram (Lexapro) DRUG

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

Also known as: Escitalopram

Escitalopram + FMT; Escitalopram + placebo

Corn Starch capsules BIOLOGICAL

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

Also known as: Corn starch

Escitalopram + placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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 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.

Sponsors & Collaborators

• Gang Wang: lead
• Shandong Daizhuang Hospital: collaborator
• Tianjin Anding Hospital: collaborator
• The First Affiliated Hospital, Zhejiang University: collaborator
• The First Hospital of Hebei Medical University: collaborator
• West China Hospital: collaborator
• Wuhu Fourth People's Hospital: collaborator

Study Sites (9)

Wuhu Fourth People's Hospital

Wuhu, Anhui, 241002, China

RECRUITING

Beijing Anding Hospital

Beijing, Beijing Municipality, 100088, China

RECRUITING

Nangfang Hospital Affiliated of Southern Medical University

Guangzhou, Guangdong, 510450, China

NOT YET RECRUITING

The First Affiliated Hospital of Hebei Medical University

Shijiazhuang, Hebei, 050000, China

RECRUITING

Shandong Daizhuang Hospital

Jining, Shandong, 272000, China

RECRUITING

West China Hospital Affiliated of Sichuan University

Chengdu, Sichuan, 610041, China

RECRUITING

Tianjin Anding Hospital

Tianjin, Tianjin Municipality, 300202, China

RECRUITING

The Second People's Hospital of Dali Bai Autonomous Prefecture

Dali, Yunnan, 671003, China

RECRUITING

The First Affiliated Hospital of Zhejiang University

Hangzhou, Zhejiang, 310000, China

RECRUITING

MeSH Terms

Conditions

Depressive Disorder, Major

Interventions

Fecal Microbiota Transplantation; Microbiota; Escitalopram; Starch

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Biological Therapy; Therapeutics; Microbiological Phenomena; Biota; Biodiversity; Ecosystem; Environment; Ecological and Environmental Phenomena; Biological Phenomena; Environment and Public Health; Propylamines; Amines; Organic Chemicals; Nitriles; Benzofurans; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Glucans; Biopolymers; Polymers; Macromolecular Substances; Dietary Carbohydrates; Carbohydrates; Polysaccharides

Central Study Contacts

Gang Wang

CONTACT

86 + 010-86430066

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Director of Beijing Anding Hospital

Study Record Dates

• First Submitted: November 14, 2024
• First Posted: November 18, 2024
• Study Start: January 1, 2025
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: December 2, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL

Locations

CN (9)