major depressive disorder
Conditions
Interventions
Test group:On the basis of using antidepressants, supplement probiotics in the morning and evening (2g/bag · time)
Control group:The control group used placebo instead of probiotics
Sponsors
Tianjin Anding Hospital, China
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Subjects voluntarily sign informed consent; 2. Age 18 ~ 65 years old (including critical value), regardless of sex; 3. Outpatient or inpatient; 4. Based on the researcher's clinical evaluation, the subjects met the diagnostic criteria for major depressive disorder in the Diagnostic and Statistical Manual of Mental Disorders-5th Edition (DSM-5); 5. The scores of 17 items of Hamilton Depression Scale (HAMD) in screening period and baseline period are >=14; 6. Use antidepressants after the onset of depression, and keep the dosage stable for 2 weeks or more. It is expected that the drugs and dosage will not be changed during the study period, and the disease is stable.
Exclusion criteria
Exclusion criteria: 1. There is a clear or severe history of attempted suicide; 2. Currently diagnosed with other psychiatric disorders other than depression according to DSM-5: schizophrenia spectrum and other psychiatric disorders or bipolar and related disorders, anxiety disorders, obsessive-compulsive and related disorders, somatic symptoms and related disorders, substance related and addictive disorders (excluding caffeine and nicotine), etc., or with positive urine drug screening for any indicator during screening; 3. Participants have received vagus nerve stimulation, transcranial magnetic stimulation, electroconvulsive therapy, or taken ketamine (including ketamine) during their current severe depressive episode; 4. Abnormal electrocardiogram results with clinical significance or abnormal laboratory test results (such as liver function exceeding 1.5 times the clinical upper limit, kidney function exceeding the upper limit, blood glucose exceeding the upper limit, abnormal cardiac troponin cTn, and significantly abnormal thyroid examination indicators), epilepsy patients or other organic brain disease patients; 5. Use any food or medication that affects probiotics in the past month or during the study period; Any antibiotics, antacids, antibacterial drugs, bismuth agents, tannic acid proteins, activated carbon, tinctures, or other drugs that affect probiotics used in the past two weeks or required during the study period; 6. Female patients who are pregnant or have a positive pregnancy test result, or male and female subjects of childbearing age who do not agree to take effective contraceptive measures throughout the entire study period and at least one month after discontinuation of medication; 7. Women who are breastfeeding; 8. Individuals who have participated in other clinical trials within one month prior to screening (excluding those who did not pass the screening and were not included); 9. Individuals who are known to have a history of allergies to any component or similar drug of the experimental product, or who have an allergic constitution (allergic to two or more drugs or foods) and are deemed unsuitable by the researcher to participate in the trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Hamilton Depression Rating Scale 17-item (HAMD-17) Score; | — |
Secondary
| Measure | Time frame |
|---|---|
| Hamilton Anxiety Scale;Beck Depression Scale;Pittsburgh Sleep Quality Index;Clinical Global Impression scale;cognitive assessment;Blood neurotransmitter;brain derived neurotrophic factor; | — |
Countries
China
Contacts
Public ContactZhongfang Yan
Tianjin Anding Hospital, China; Tianjin Mental Health Center
Outcome results
None listed