Depressive Disorders
Conditions
Interventions
Placebo group:take placebo until the end of follow-up
postbiotic group:From the start of postnatal supplementation until the end of follow-up
Probiotic Group:take probiotics until the end of follow-up
Sponsors
The first affiliated hostipal of nanchang university
Eligibility
Sex/Gender
All
Age
13 Years to 18 Years
Inclusion criteria
Inclusion criteria: 1)Age range: Adolescents aged 13-18 years. 2)Diagnostic criteria: Meeting commonly used clinical diagnostic criteria for depression, such as those for depression in the International Classification of Diseases, 10th Revision (ICD-10), including core symptoms (e.g., low mood, loss of interest, etc.) and accompanying symptoms (e.g., changes in appetite, sleep disturbances, etc.). 3) Severity of depression: Assessed using commonly used depression scales, including the Children's Depression Rating Scale-Revised (CDRS-R), Montgomery-Asberg Depression Rating Scale (MADRS), Clinical Global Impression (CGI), and Beck Depression Inventory (BDI), with severity reaching mild depression (e.g., a total score of 30-39 on the CDRS-R, etc.). Note: CDRS-R and MADRS focus on symptom severity and are suitable for efficacy assessment; CGI is a rapid overall assessment tool for clinicians, suitable for judging efficacy endpoints; CGAS focuses on functional recovery and is recommended for long-term follow-up. BDI is widely used in clinical studies involving adolescents aged 13 years and older and adults. 4)Informed consent: Adolescents and their legal guardians voluntarily participate in the study and sign the informed consent form. 5)Health status: No severe physical diseases (e.g., heart disease, liver or kidney failure, etc.) that could potentially affect depressive symptoms; subjects are in generally good physical condition and able to tolerate probiotic intervention. 6)Compliance assessment: Expected to complete all intervention measures and follow-up examinations as required by the trial, with good compliance.
Exclusion criteria
Exclusion criteria: 1) Other mental illnesses: Suffering from other severe mental illnesses such as bipolar disorder and schizophrenia, as these diseases may interfere with the assessment of depressive symptoms and the judgment of treatment effects. 2) Medication use: Having taken antidepressants or other drugs that may affect the neuropsychiatric system within the past month, to avoid drug-related factors interfering with the judgment of the efficacy of probiotics. 3) Intestinal diseases: Having severe intestinal diseases (e.g., inflammatory bowel disease, intestinal infection, etc.), as these diseases themselves may alter the intestinal flora and may have complex impacts on the tolerance and effects of probiotics. 4) Allergy history: Being allergic to probiotics or their excipients, to prevent allergic reactions from disrupting the smooth progress of the study and compromising the safety of the subjects. 5) Drug abuse or addiction: Having a history of drug abuse (e.g., abuse of sedatives, hypnotics, stimulants, etc.) or alcohol or substance addiction, as these factors may affect physiological mechanisms such as brain neurotransmitters and interfere with the observation of the therapeutic effect on depression. 6) Recent surgical history: Having undergone abdominal surgery (e.g., gastrointestinal surgery, etc.) within the past three months, as surgery may have a significant impact on intestinal function and flora. 7) A history of antibiotic use within the past month.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Whether the body temperature is abnormally elevated or decreased.;the immune system and hematopoietic function status of the subjects;the function of the urinary system and whether there are other potential diseases;Changes in blood pressure and heart rate can reflect the functional status of the cardiovascular system.;the liver and kidney functions, metabolic status of the subjects and whether there are metabolic abnormalities;Changes in CDRS-R scores before and after treatment;whether the subjects have other potential diseases or physical abnormalities.;Detect the vitamin D content in the serum to find out whether the subjects have vitamin D deficiency.;Test the thyroid hormone levels to evaluate whether there is abnormal thyroid function.;Gut microbiota; | — |
Secondary
| Measure | Time frame |
|---|---|
| Changes in CGI scores;Changes in MADRS scores;Changes in BDI scores;Changes in PSQI scores; | — |
Countries
China
Contacts
Public ContactMengqian li
The first affiliated hostipal of nanchang university
Outcome results
None listed