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

Gang Wang214 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

214

Conditions

Major Depressive Disorder (MDD)Depression - Major Depressive Disorder

Interventions

FMT capsuleBIOLOGICAL

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)DRUG

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

Corn Starch capsulesBIOLOGICAL

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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.

Locations (9)

Wuhu Fourth People's Hospital

Wuhu, Anhui, China

RECRUITING

Beijing Anding Hospital

Beijing, Beijing Municipality, China

RECRUITING

Outcomes

Primary Outcomes

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.

Time frame: Baseline, Week 4, Week 8

Secondary Outcomes

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

The Hamilton Depression Rating Scale-17 (HAMD-17) was used to assess the severity of depression in patients. 4 weeks after 4-week treatments, the differences in complete remission rate (HAMD-17 ≤ 7 points) between the two groups will be compared.

Time frame: Baseline, Week 4, Week 8

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

At the end of 4-week treatments, the differences in effective rate(HAMD-17 score reduction rate ≥ 50%) between the two groups will be compared.

Time frame: Baseline and Week 4

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

At the end of 4-week treatments, the differences in complete remission rate(HAMD-17 ≤ 7 points) between the two groups will be compared.

Time frame: Baseline and Week 4

Changes in total score of GAD-7 scale

Changes in the total score of the Generalized Anxiety Disorder-7(GAD-7) scale at each follow-up time (0,4,8 and 20 weeks after 4-week treatments) will be compared with the total score at baseline.

Time frame: Baseline, Week 4, Week 8, Week 12, Week 24

Changes in total score of QIDS-SR scale

Central Contacts

Gang Wang

CONTACT

86 + 010-86430066

Data from ClinicalTrials.gov

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