Tests fecal microbiota transplant capsules alongside escitalopram for depression
Tests gut bacteria capsules in adults with major depression who respond poorly to antidepressants.
Plain-language title generated from the registry record
Registry title: Assessment of the Efficacy and Safety of Fecal Microbiota Transplantation (FMT) in Patients With Major Depressive Disorder
Key facts
- Where
- Beijing, Chengdu, Dali, Guangzhou, Hangzhou, Jining, Shijiazhuang, Tianjin, and Wuhu, ChinaSee the 9 sites
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with major depressive disorder who improved little after 2 weeks of escitalopram and who have not been treated with medicine for the current depressive episode.
- Age
- 18 to 65 years
- Sex
- All sexes can join.
- Disease stage
- Major depressive disorder (single episode or recurrent) with a HAMD-17 score of 17 or more at the start. After 2 weeks of the maximum tolerated dose of escitalopram, the HAMD-17 score fell by less than 20%.
- Earlier treatment
- No medicine treatment for the current depressive episode before screening. Plan to be treated with escitalopram alone. No antibiotics, probiotics, prebiotics or traditional Chinese medicine products for more than 2 weeks within 3 months before enrolment. No MECT in the past 6 months.
Main reasons for not taking part
- Bipolar disorder, schizophrenia spectrum or other psychotic disorders, neurodevelopmental or neurocognitive disorders, or substance-related disorders
- Serious suicide risk (HAMD-17 suicide item of 3 points or more)
- Gastrointestinal infections, tumours or structural problems of the digestive system, or past gastrointestinal surgery
- Pregnant or breastfeeding
- Cannot or will not swallow capsules, or allergic to the capsule ingredients
Read by machine on 9 November 2026.
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 65 years old?
Source: NCT06692361, who can take part
Where in China
- Beijing Anding HospitalBeijing, ChinaTaking people
- West China Hospital Affiliated of Sichuan UniversityChengdu, ChinaTaking people
- The Second People's Hospital of Dali Bai Autonomous PrefectureDali, ChinaTaking people
- Nangfang Hospital Affiliated of Southern Medical UniversityGuangzhou, ChinaNot yet recruiting
- The First Affiliated Hospital of Zhejiang UniversityHangzhou, ChinaTaking people
- Shandong Daizhuang HospitalJining, ChinaTaking people
- The First Affiliated Hospital of Hebei Medical UniversityShijiazhuang, ChinaTaking people
- Tianjin Anding HospitalTianjin, ChinaTaking people
- Wuhu Fourth People's HospitalWuhu, ChinaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Gang Wang
- Trial code
- NCT06692361
- Record updated
- 2 December 2025
- Original description
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 MDDRead full original descriptionShow less
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
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
Inclusion: 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: 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; 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; Patients who received MECT treatment in the past 6 months; 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; 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; Those who are allergic to capsule ingredients and contents; 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; Pregnant or lactating patients; Patients who are unable (such as difficulty swallowing) or unwilling to swallow capsules.