Depression
Conditions
Interventions
Health Group:None
Placebo group:On the basis of conventional real-world treatment with escitalopram, PS128 placebo intervention was administered
PS128 group:PS128 intervention is given on the basis of conventional real-world treatment with escitalopram
Sponsors
The First Affiliated Hospital of Ningbo University
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Age 18-65 years old, gender is not limited; 2. Meet the ICD-10 classification criteria for mild (1 core symptom and 2 concomitant symptoms), moderate (2 core symptoms + 3-4 concomitant symptoms), severe (3 core symptoms and 4 other symptoms) depression; 3. The core symptoms of depression and the accompanying symptoms >=2 weeks; 4. Patient Health Questionnaire Depression Self-Rating Scale PHQ-9 score >=10 points, HAMD-17 score >=18 points (and the first item depression score >=2), MADRS score >=22 points, CGI-S score >=4 points; 5. Stable use of drugs in the past three months; 6. Be able to understand the content of the scale and cooperate with the research; 7. Voluntarily participate in this study and sign the informed consent form.
Exclusion criteria
Exclusion criteria: 1. Severe mental illnesses such as schizophrenia and bipolar disorder, organic mental disorders, and depressive symptoms caused by physical diseases; 2. The patient is currently at serious suicide risk, with a score of >=3 on the HAMD-17 suicide risk item or a score of 2 on question 9 > the PHQ-9 scale; 3. Have taken probiotics or synbiotic products (except yogurt, lactic acid bacteria drinks and other foods) within four weeks or are allergic to probiotics; 4. Have taken or are receiving antibiotic treatment within one month; 5. Gastrointestinal surgery in the past year; 6. Addicted to tobacco, alcohol, caffeine and drugs; 7. Other situations in which the investigator considers the patient to be unsuitable to participate in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Hamilton Depression Rating Scale-17 , HAMD-17;Montgomery-?sberg Depression Rating Scale, MADRS;16S rRNA detection;Short Chain Fatty Acids Quantitative Analysis, SCFAs;Salivary cortisol; | — |
Secondary
| Measure | Time frame |
|---|---|
| Clinical Global Impression - Severity, CGI-S;Patient Health Questionnaire-9, PHQ-9; | — |
Countries
China
Contacts
Public ContactJi Yunxin
The First Affiliated Hospital of Ningbo University
Outcome results
None listed