Using fecal microbiota transplantation to treat major depressive disorder

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This multicenter, randomized, double-blind, placebo-controlled study evaluates the efficacy and safety of fecal microbiota transplantation (FMT) in patients with major depressive disorder (MDD) who have shown a suboptimal response to initial antidepressant treatment. A total of 600 patients will be screened, with 214 participants who do not respond adequately to escitalopram being randomized to receive either FMT capsules or a placebo for four weeks, while continuing their antidepressant regimen. The study will also assess the impact of FMT on biological indicators such as intestinal microbiota and metabolites over a 20-week follow-up period.

Why it matters

Who can join: the full rules

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.

Where it's running

• Wuhu Fourth People's Hospital
  Wuhu, Anhui, China Recruiting
• Beijing Anding Hospital
  Beijing, Beijing Municipality, China Recruiting
• The First Affiliated Hospital of Hebei Medical University
  Shijiazhuang, Hebei, China Recruiting
• Shandong Daizhuang Hospital
  Jining, Shandong, China Recruiting
• West China Hospital Affiliated of Sichuan University
  Chengdu, Sichuan, China Recruiting
• Tianjin Anding Hospital
  Tianjin, Tianjin Municipality, China Recruiting

Study contacts

• Study coordinator: Gang Wang
• Phone: 86 + 010-86430066

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.