Assessment of the Efficacy and Safety of Fecal Microbiota Transplantation (FMT) in Patients With Major Depressive Disorder
NCT ID: NCT06692361
Last Updated: 2025-12-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
NA
214 participants
INTERVENTIONAL
2025-01-01
2026-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Characterization of Microbial, Immune and Epigenetic Biomarkers for Major Depressive Disorder and ECT Treatment
NCT03703414
Evaluating the Role of the Microbiome in Antidepressant Treatment in Adolescents.
NCT06633497
Microbiome of Depression & Treatment Response to Citalopram
NCT02330068
A Safety and Efficacy Study of Escitalopram on Acute Treatment of Severe Depression
NCT01814085
Effect of Antidepressants on the Treatment for Korean Major Depressive Disorder Patients
NCT00926835
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Escitalopram + FMT
The experimental group will receive escitalopram + FMT capsules (using Oral capsules derived from healthy human fecal microbiota)
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.
Escitalopram (Lexapro)
Both the experimental group and the placebo group were treated with the maximum tolerated dose of escitalopram.
Escitalopram + placebo
The control group will be treated with escitalopram + placebo (using capsules containing only corn starch)
Escitalopram (Lexapro)
Both the experimental group and the placebo group were treated with the maximum tolerated dose of escitalopram.
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.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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.
Escitalopram (Lexapro)
Both the experimental group and the placebo group were treated with the maximum tolerated dose of escitalopram.
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.
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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.
18 Years
65 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Shandong Daizhuang Hospital
UNKNOWN
Tianjin Anding Hospital
OTHER
The First Affiliated Hospital, Zhejiang University
UNKNOWN
The First Hospital of Hebei Medical University
OTHER
West China Hospital
OTHER
Wuhu Fourth People's Hospital
UNKNOWN
Gang Wang
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Gang Wang
Director of Beijing Anding Hospital
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
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
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Gang Wang
Role: CONTACT
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Gang Wang
Role: primary
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
No. 2024-58
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.