Major Depressive Disorder
Conditions
Interventions
Probiotic group:Huayong No.1 Compound Probiotics
Placebo group:Huayong No.1 Compound Probiotic Placebo
Sponsors
The Affiliated Brain Hospital of Guangzhou Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 45 Years
Inclusion criteria
Inclusion criteria: 1. Meet the diagnostic criteria for Depressive Episode in the International Classification of Diseases, 10th Revision (ICD-10); 2. Aged 18 to 45 years, with an education level of junior high school or above, and capable of understanding the content of the scales and complying with the treatment regimen; 3. Score > 17 points on the 17-item Hamilton Depression Rating Scale (HAMD-17); 4. Total score >= 14 points on the Hamilton Anxiety Rating Scale (HAMA), AND score >= 2 points on Item 11 (Gastrointestinal Symptoms) of HAMA; 5. Score < 6 points on the Young Manic Rating Scale (YMRS); 6. Have signed the informed consent form and voluntarily participate in this study.
Exclusion criteria
Exclusion criteria: 1. Patients with suicidal tendency; 2. Patients with a previous diagnosis of intellectual disability, schizophrenia, bipolar disorder, substance use disorder (e.g., alcohol dependence), or other mental disorders; 3. Patients with a history of epileptic seizures, strong positive family history of epilepsy, organic brain disease, or severe systemic disease; 4. Patients with special dietary habits, those who have taken antibiotics or probiotics within 3 months prior to screening, or those with comorbid gastrointestinal diseases or functional disorders; 5. Pregnant women, women planning pregnancy, or lactating (breastfeeding) women; 6. Patients with comorbid skin lesions or dermatological diseases, severe diabetes mellitus, tumors, insufficiency of vital organs, or severe medical diseases involving the liver, kidney, cardiovascular, endocrine, respiratory, and hematopoietic systems; 7. Patients with other central or peripheral nervous system disorders.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in Hamilton Depression Rating Scale score after treatment;Change in Hamilton Anxiety Scale score after treatment;Change in Young Mania Rating Scale score after treatment;Change in Gastrointestinal Symptom Rating Scale score after treatment;Change in MATRICS Consensus Cognitive Battery score after treatment; | — |
Countries
China
Contacts
Public ContactHehua Li
The Affiliated Brain Hospital of Guangzhou Medical University
Outcome results
None listed