NCT06692361 Assessment of the Efficacy and Safety of Fecal Microbiota Transplantation (FMT) in Patients With Major Depressive Disorder
| NCT ID | NCT06692361 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Gang Wang |
| Condition | Major Depressive Disorder (MDD) |
| Study Type | INTERVENTIONAL |
| Enrollment | 214 participants |
| Start Date | 2025-01-01 |
| Primary Completion | 2026-06 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 214 participants in total. It began in 2025-01-01 with a primary completion date of 2026-06.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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
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.
Contact & Investigator
Gang Wang
📞 86 + 010-86430066
Frequently Asked Questions
Who can join the NCT06692361 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 65 Years, studying Major Depressive Disorder (MDD). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06692361 currently recruiting?
Yes, NCT06692361 is actively recruiting participants. Visit ClinicalTrials.gov or contact Gang Wang to inquire about joining.
Where is the NCT06692361 trial being conducted?
This trial is being conducted at Wuhu, China, Beijing, China, Guangzhou, China, Shijiazhuang, China and 5 additional locations.
Who is sponsoring the NCT06692361 clinical trial?
NCT06692361 is sponsored by Gang Wang. The trial plans to enroll 214 participants.