Using fecal microbiota transplantation to treat major depressive disorder

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 is testing if a treatment using gut bacteria from healthy donors can help people with major depressive disorder who haven't responded well to their current antidepressants feel better.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 214 (estimated)
• Ages: 18 Years to 65 Years
• Sex: All
• Sponsor: Capital Medical University (Academic / other)
• Locations: 9 sites (Wuhu, Anhui and 8 other locations)
• Trial ID: NCT06692361 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 65 with recurrent or single-episode major depressive disorder who have not responded adequately to initial treatment with escitalopram.

Not a fit: Patients who have been treated with medication for their current depressive episode or those with a HAMD-17 score indicating a significant response to escitalopram may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could provide a novel treatment option for patients with major depressive disorder who do not respond well to conventional antidepressant therapies.

How similar studies have performed: While the use of fecal microbiota transplantation in mental health is a relatively novel approach, preliminary studies have shown promising results, indicating potential for success.

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.

Where this trial is running

Wuhu, Anhui and 8 other locations

• Wuhu Fourth People's Hospital — Wuhu, Anhui, China (Recruiting)
• Beijing Anding Hospital — Beijing, Beijing Municipality, China (Recruiting)
• Nangfang Hospital Affiliated of Southern Medical University — Guangzhou, Guangdong, China (Not_yet_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)
• The Second People's Hospital of Dali Bai Autonomous Prefecture — Dali, Yunnan, China (Recruiting)
• The First Affiliated Hospital of Zhejiang University — Hangzhou, Zhejiang, China (Recruiting)

Study contacts

• Study coordinator: Gang Wang

Conditions Major Depressive Disorder; Depression - Major Depressive Disorder; faecal microbiota transplantation; microbiome; major depressive disorder; RCT