Major Depressive Disorder (MDD)NCT06692361
Assessment of the Efficacy and Safety of Fecal Microbiota Transplantation (FMT) in Patients With Major Depressive Disorder
A study testing FMT capsule, Escitalopram (Lexapro) and Corn Starch capsules in people with Major Depressive Disorder (MDD) and Depression - Major Depressive Disorder, run by Gang Wang at 9 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Major Depressive Disorder (MDD), Depression - Major Depressive Disorder
- What is being tested?
- FMT capsule, Escitalopram (Lexapro) and Corn Starch capsules
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 214 participants
- Where
- 9 sitesChina
- Study dates
- 1 Jan 2025to Dec 2026
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.;
Show all 12Show fewer
- 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.
Trial locations and contacts
9 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Gang Wang contact
9 sites in 1 country
China9 sites, 9 recruiting
- Recruiting
Beijing Anding Hospital
Beijing, Beijing Municipality, 100088
Gang Wang, 86 + 010-86430066
- Recruiting
West China Hospital Affiliated of Sichuan University
Chengdu, Sichuan, 610041
- Recruiting
The Second People's Hospital of Dali Bai Autonomous Prefecture
Dali, Yunnan, 671003
- Not yet recruiting
Nangfang Hospital Affiliated of Southern Medical University
Guangzhou, Guangdong, 510450
- Recruiting
The First Affiliated Hospital of Zhejiang University
Hangzhou, Zhejiang, 310000
- Recruiting
Shandong Daizhuang Hospital
Jining, Shandong, 272000
- Recruiting
The First Affiliated Hospital of Hebei Medical University
Shijiazhuang, Hebei, 050000
- Recruiting
Tianjin Anding Hospital
Tianjin, Tianjin Municipality, 300202
- Recruiting
Wuhu Fourth People's Hospital
Wuhu, Anhui, 241002
About this study
Official title: 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
Read the detailed description
This multicenter, randomized, double-blind, placebo-controlled study aims to compare the efficacy and safety of adjunctive FMT in patients with major depressive disorder (MDD) who show limited response to initial drug therapy.
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.
- Being tested
- FMT capsule, Escitalopram (Lexapro), Corn Starch capsules
- Keywords
- faecal microbiota transplantation, microbiome, major depressive disorder, RCT
- Medical subject headings
- Depressive Disorder, Major
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FMT capsuleBiological
Also called microbiota capsule, FMT
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)Drug
Also called Escitalopram
Both the experimental group and the placebo group were treated with the maximum tolerated dose of escitalopram.
Corn Starch capsulesBiological
Also called Corn starch
The placebo group will maintain escitalopram treatment and take corn starch capsules 1.0 g orally with breakfast every day for 4 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Escitalopram + FMT | Experimental | The experimental group will receive escitalopram + FMT capsules (using Oral capsules derived from healthy human fecal microbiota) Receives: Biological: FMT capsule; Drug: Escitalopram (Lexapro) |
| Escitalopram + placebo | Placebo comparator | The control group will be treated with escitalopram + placebo (using capsules containing only corn starch) Receives: Drug: Escitalopram (Lexapro); Biological: Corn Starch capsules |
What is being measured
The primary outcome is the main question the study is designed to answer.
The differences in efficacy(HAMD-17 score reduction rate ≥50%) between the two groups
The Hamilton Depression Rating Scale-17(HAMD-17) was used to assess the severity of depression in patients. If the HAMD-17 score reduction rate was ≥50%, the treatment was considered effective. 4 weeks after 4-week treatments, the differences in the effective rate of treatment between the two groups will be compared.
Measured: Baseline, Week 4, Week 8
Secondary outcomes (15)
The differences in complete remission rate(HAMD-17 ≤ 7 points) between the two groups
The Hamilton Depression Rating Scale-17 (HAMD-17) was used to assess the severity of depression in patients. 4 weeks after 4-week treatments, the differences in complete remission rate (HAMD-17 ≤ 7 points) between the two groups will be compared.
Measured: Baseline, Week 4, Week 8
The differences in effective rate(HAMD-17 score reduction rate ≥50%)
At the end of 4-week treatments, the differences in effective rate(HAMD-17 score reduction rate ≥ 50%) between the two groups will be compared.
Measured: Baseline and Week 4
The differences in complete remission rate(HAMD-17 ≤ 7 points) between the two groups
At the end of 4-week treatments, the differences in complete remission rate(HAMD-17 ≤ 7 points) between the two groups will be compared.
Measured: Baseline and Week 4
Changes in total score of GAD-7 scale
Changes in the total score of the Generalized Anxiety Disorder-7(GAD-7) scale at each follow-up time (0,4,8 and 20 weeks after 4-week treatments) will be compared with the total score at baseline.
Measured: Baseline, Week 4, Week 8, Week 12, Week 24
Changes in total score of QIDS-SR scale
Quick Inventory of Depressive Symptoms-Self Rated(QIDS-SR) is mainly used to assess the severity of depressive symptoms. It includes 9 symptoms for depression diagnosis. QIDS-SR is very sensitive to changes in depressive symptoms. Changes in the total score of QIDS-SR scale at each follow-up time (0,4,8 and 20 weeks after 4-week treatments) will be compared with the total score at baseline.
Measured: Baseline, Week 4, Week 8, Week 12, Week 24
The differences in the reduction scores of the HAMD-17 scale in 4 symptom dimensions
The differences in the reduction scores of the HAMD-17 scale in 4 different symptom dimensions at each follow-up time (0,4,8 and 20 weeks after 4-week treatments) was recorded: depression (1/2/3/7/8 items), anxiety (9/10/11/15/17 items), insomnia (4/5/6 items), and somatic (12/13/14/16 items).
Measured: Baseline, Week 4, Week 8, Week 12, Week 24
Changes in total score of GSRS scale
The investigators will use the 7-level rating version of the Gastrointestinal Symptom Rating Scale(GSRS). Changes in the total score of the GSRS scale at each follow-up time (0,4,8 and 20 weeks after 4-week treatments) will be compared with the total score at baseline.
Measured: Baseline, Week 4, Week 8, Week 12, Week 24
Changes in total score of SF-12 scale
Changes in the total score of the Short Form 12 Health Survey(SF-12) scale at each follow-up time (0,4,8 and 20 weeks after 4-week treatments) will be compared with the total score at baseline.
Measured: Baseline, Week 4, Week 8, Week 12, Week 24
Changes in total score of SDS scale
Changes in the total score of the Sheehan Disability Scale(SDS) scale at each follow-up time (0,4,8 and 20 weeks after 4-week treatments) will be compared with the total score at baseline.
Measured: Baseline, Week 4, Week 8, Week 12, Week 24
Changes in total score of PDQ-5D scale
Changes in the total score of the Perceived Deficit Questionnaire for Depression 5-item(PDQ-5D) scale at each follow-up time (0,4,8 and 20 weeks after 4-week treatments) will be compared with the total score at baseline.
Measured: Baseline, Week 4, Week 8, Week 12, Week 24
Changes of each subscale of CBCT
Changes of each subscale of the Cognitive Behavioral Assessment Tool(CBCT) at each follow-up time (0,4,8 and 20 weeks after 4-week treatments) will be compared with the total score at baseline.
Measured: Baseline, Week 4, Week 8, Week 12, Week 24
Changes of each subscale of CGI
Changes of each subscale of the Clinical Global Impressions(CGI) at each follow-up time (0,4,8 and 20 weeks after 4-weeks treatments) will be compared with the total score at baseline.
Measured: Baseline, Week 4, Week 8, Week 12, Week 24
Changes of each subscale of PSQI
Changes of each subscale of the Pittsburgh sleep quality index(PSQI) at each follow-up time (0,4,8 and 20 weeks after 4-week treatments) will be compared with the total score at baseline.
Measured: Baseline, Week 4, Week 8, Week 12, Week 24
Changes in brain imaging and EEG indicators
Changes in brain imaging and Electroencephalogram(EEG) indicators at each follow-up time (4,8 and 20 weeks after 4-week treatments) will be compared with the total score at baseline.
Measured: Baseline, Week 4, Week 8, Week 12, Week 24
Evaluation of the safety of the treatments
The investigators will record any adverse events reported by participants, after treatments at each follow-up time (4,8 and 20 weeks after 4-week treatments).
Measured: Baseline, Week 4, Week 8, Week 12, Week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2024
- Study start1 Jan 2025
- Primary completionJun 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Major Depressive Disorder (MDD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 214 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gang Wang
- Sponsor type
- University, hospital or other
- Collaborators
- Shandong Daizhuang Hospital, Tianjin Anding Hospital, First Affiliated Hospital of Zhejiang University, The First Hospital of Hebei Medical University, West China Hospital, Wuhu Fourth People's Hospital
- Responsible party
- Sponsor-investigator, Gang Wang, Capital Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06692361
- Sponsor's protocol ID
- No. 2024-58
- Status last verified
- Mar 2025
- First submitted
- 14 Nov 2024
- Last updated
- 2 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes