Assessment of the Efficacy and Safety of Fecal Microbiota Transplantation (FMT) in Patients with Major Depressive Disorder
- Conditions
- Major Depressive Disorder (MDD)Depression - Major Depressive Disorder
- Interventions
- Registration Number
- NCT06692361
- Lead Sponsor
- Gang Wang
- 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
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 214
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Escitalopram + FMT FMT capsule The experimental group will receive escitalopram + FMT capsules (using Oral capsules derived from healthy human fecal microbiota) Escitalopram + FMT Escitalopram (Lexapro) The experimental group will receive escitalopram + FMT capsules (using Oral capsules derived from healthy human fecal microbiota) Escitalopram + placebo Escitalopram (Lexapro) The control group will be treated with escitalopram + placebo (using capsules containing only corn starch) Escitalopram + placebo Corn Starch capsules The control group will be treated with escitalopram + placebo (using capsules containing only corn starch)
- Primary Outcome Measures
Name Time Method The differences in efficacy(HAMD-17 score reduction rate ≥50%) between the two groups Baseline, Week 4, Week 8 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.
- Secondary Outcome Measures
Name Time Method The differences in complete remission rate(HAMD-17 ≤ 7 points) between the two groups Baseline and Week 4 At the end of 4-week treatments, the differences in complete remission rate(HAMD-17 ≤ 7 points) between the two groups will be compared.
The differences in effective rate(HAMD-17 score reduction rate ≥50%) Baseline and Week 4 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.
Changes in total score of GAD-7 scale Baseline, Week 4, Week 8, Week 12, Week 24 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.
Changes in total score of QIDS-SR scale Baseline, Week 4, Week 8, Week 12, Week 24 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.
The differences in the reduction scores of the HAMD-17 scale in 4 symptom dimensions Baseline, Week 4, Week 8, Week 12, Week 24 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).
Changes in total score of GSRS scale Baseline, Week 4, Week 8, Week 12, Week 24 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.
Changes in total score of SF-12 scale Baseline, Week 4, Week 8, Week 12, Week 24 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.
Changes in total score of SDS scale Baseline, Week 4, Week 8, Week 12, Week 24 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.
Changes in total score of PDQ-5D scale Baseline, Week 4, Week 8, Week 12, Week 24 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.
Changes of each subscale of CBCT Baseline, Week 4, Week 8, Week 12, Week 24 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.
Changes of each subscale of CGI Baseline, Week 4, Week 8, Week 12, Week 24 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.
Changes of each subscale of PSQI Baseline, Week 4, Week 8, Week 12, Week 24 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.
Changes in brain imaging and EEG indicators Baseline, Week 4, Week 8, Week 12, Week 24 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.
Evaluation of the safety of the treatments Baseline, Week 4, Week 8, Week 12, Week 24 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).
Trial Locations
- Locations (7)
Wuhu Fourth People's Hospital
🇨🇳Wuhu, Anhui, China
Beijing Anding Hospital
🇨🇳Beijing, Beijing, China
The First Hospital of Hebei Medical University
🇨🇳Shijiazhuang, Hebei, China
Shandong Daizhuang Hospital
🇨🇳Jining, Shandong, China
West China Hospital Affiliated with sichuan University
🇨🇳Chengdu, Sichuan, China
Tianjin Anding Hospital
🇨🇳Tianjin, Tianjin, China
The First Affiliated Hospital, Zhejiang University
🇨🇳Hangzhou, Zhejiang, China