Depressive Disorders
Conditions
Interventions
Control group:Take one sachet once daily with warm water, continuing for three months
Experimental group:Take one sachet of oral Clostridium butyricum preparation once daily with warm water. Continue for 3 months
Sponsors
The First Affiliated Hospital of Nanchang University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Age range: Adolescents aged 13-18 years; 2. Diagnostic criteria: Meets commonly used clinical diagnostic criteria for depression, such as the diagnostic criteria for depression in the International Classification of Diseases, 10th Edition (ICD-10), including core symptoms (such as low mood, loss of interest, etc.) and accompanying symptoms (such as changes in appetite, sleep disturbances, etc.); 3. Severity of Depression: Assessed using commonly used depression rating scales such as the Children's Depression Rating Scale-Revised (CDRS-R), the Montgomery-Åsberg Depression Rating Scale (MADRS), the Clinical Global Impression (CGI), and the Beck Depression Inventory (BDI). Patients should reach moderate to severe depression (e.g., CDRS-R total score >= 41, etc.); Note: CDRS-R and MADRS focus on symptom severity and are suitable for evaluating treatment efficacy; CGI is a quick overall assessment tool for clinicians, suitable for determining treatment endpoints; CGAS focuses on functional recovery and is recommended for long-term follow-up. BDI is widely used in clinical studies of adolescents aged 13 and older, as well as adults. 4. Informed Consent: Adolescents and their legal guardians voluntarily participate in the study and sign an informed consent form; 5. Health status: No serious physical illnesses (such as heart disease, liver or kidney failure, etc.) that could potentially affect depressive symptoms. General physical condition is good and able to tolerate probiotic intervention; 6. Compliance assessment: Expected to complete all interventions and follow-up examinations as required by the trial, with good compliance.
Exclusion criteria
Exclusion criteria: 1. Other mental disorders: Individuals with other major mental disorders such as bipolar disorder or schizophrenia, as these conditions may interfere with the assessment of depressive symptoms and the evaluation of treatment effects; 2. Medication use: Those who have taken other drugs that may affect the neuropsychiatric system in the past month, to avoid interference from medication factors in judging the effects of probiotics; 3. Intestinal diseases: Individuals with severe intestinal diseases (such as inflammatory bowel disease or intestinal infections), as these conditions may themselves alter gut microbiota and could have complex effects on the tolerance and efficacy of probiotics; 4. Allergy history: Allergic to probiotics or their excipients, to avoid allergic reactions that could affect the study's progress and ensure the safety of participants; 5. Drug abuse or addiction: History of drug abuse (such as abuse of sedatives, hypnotics, stimulants, etc.) or alcohol/substance addiction, as these factors may affect brain neurotransmitter mechanisms and interfere with observing the treatment effects for depression; 6. Recent surgical history: Underwent abdominal surgery (such as gastrointestinal surgery) within the past three months, because surgery may have a significant impact on intestinal function and microbiota; 7. History of antibiotic use within the past month.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Changes in Children's Depression Rating Scale-Revised (CDRS-R) scores after 3 months of treatment;Body temperature measurement;Urine routine;Physical examination;Biochemical examination;Detect the vitamin D content in the serum to find out whether the subjects have vitamin D deficiency.;Thyroid function test;Feces;Complete Blood Count;Blood pressure and heart rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Changes in PSQI scores;Changes in CGI scores;Changes in BDI scores;Changes in MADRS scores; | — |
Countries
China
Contacts
Public ContactMengqian li
The First Affiliated Hospital of Nanchang University
Outcome results
None listed