Assessment of the Efficacy and Safety of Fecal Microbiota Transplantation (FMT) in Patients With Major Depressive Disorder
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: FMT capsule, Escitalopram (Lexapro), Corn Starch capsules.
- Who it may be relevant to
- Registry conditions: Major Depressive Disorder (MDD), Depression - Major Depressive Disorder. Basic parameters: 18 years — 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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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
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
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.
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.
Primary outcome measures
- The differences in efficacy(HAMD-17 score reduction rate ≥50%) between the two groups [Time frame: Baseline, Week 4, Week 8]
Secondary outcome measures (12)
- The differences in complete remission rate(HAMD-17 ≤ 7 points) between the two groups [Time frame: Baseline, Week 4, Week 8]
- The differences in effective rate(HAMD-17 score reduction rate ≥50%) [Time frame: Baseline and Week 4]
- The differences in complete remission rate(HAMD-17 ≤ 7 points) between the two groups [Time frame: Baseline and Week 4]
- Changes in total score of GAD-7 scale [Time frame: Baseline, Week 4, Week 8, Week 12, Week 24]
- Changes in total score of QIDS-SR scale [Time frame: Baseline, Week 4, Week 8, Week 12, Week 24]
- The differences in the reduction scores of the HAMD-17 scale in 4 symptom dimensions [Time frame: Baseline, Week 4, Week 8, Week 12, Week 24]
- Changes in total score of GSRS scale [Time frame: Baseline, Week 4, Week 8, Week 12, Week 24]
- Changes in total score of SF-12 scale [Time frame: Baseline, Week 4, Week 8, Week 12, Week 24]
- Changes in total score of SDS scale [Time frame: Baseline, Week 4, Week 8, Week 12, Week 24]
- Changes in total score of PDQ-5D scale [Time frame: Baseline, Week 4, Week 8, Week 12, Week 24]
- Changes of each subscale of CBCT [Time frame: Baseline, Week 4, Week 8, Week 12, Week 24]
- Changes of each subscale of CGI [Time frame: Baseline, Week 4, Week 8, Week 12, Week 24]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Triple blind
- Primary purpose
- Treatment
Study locations
China · 9 centers
- Wuhu Fourth People's Hospital — Wuhu
- Beijing Anding Hospital — Beijing
- Nangfang Hospital Affiliated of Southern Medical University — Guangzhou
- The First Affiliated Hospital of Hebei Medical University — Shijiazhuang
- Shandong Daizhuang Hospital — Jining
- West China Hospital Affiliated of Sichuan University — Chengdu
- Tianjin Anding Hospital — Tianjin
- The Second People's Hospital of Dali Bai Autonomous Prefecture — Dali
- … and 1 more center
Identifiers
NCT: NCT06692361 · No. 2024-58