Depressive Disorder
Conditions
Interventions
:Conduct non-targeted serum metabolomics and metagenomics testing
Sponsors
Xiyuan Hospital of China Academy of Chinese Medical Science
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1.Subjects must meet the diagnostic criteria for depression according to the DSM-V; only those who also meet the aforementioned five criteria will be included in the study. 2.Subjects should be diagnosed with Traditional Chinese Medicine as having either a deficiency of both the heart and spleen or a condition of liver qi stagnation transforming into fire. 3.Subjects must be aged between 18 and 65 years regardless of gender. 4.The Hamilton Depression Rating Scale (HAMD) score must be between =8 and =24 with a score of =2 on the depressive mood item of the HAMD. 5.Subjects must agree to and sign an informed consent form.
Exclusion criteria
Exclusion criteria: 1.Subjects with suicidal tendencies indicated by a score of =2 on the HAMD suicide item. 2.Subjects with severe anxiety symptoms indicated by a Hamilton Anxiety Rating Scale (HAMA) score of =29. 3.Subjects with severe or unstable medical conditions affecting the heart liver kidneys endocrine system blood etc. 4.Depression episodes secondary to somatic diseases. 5.Subjects previously diagnosed with organic mental disorders schizophrenia or bipolar affective disorder. 6.Depression disorders induced by psychoactive substances (such as alcohol tobacco opioids etc.) and non-addictive substances. 7.Subjects who have taken sedative-hypnotic or antidepressant medications (such as risperidone olanzapine etc.) or traditional Chinese medicines (such as Xiao Yao Wan Wu Ling Capsule Shu Gan Jie Yu Capsule etc.) within the past month. 8.Subjects who have taken antibiotics probiotics or gastrointestinal motility medications within three months prior to sampling. 9.Subjects with gastrointestinal diseases such as diarrhea gastritis gastrointestinal ulcers or inflammatory bowel disease within three months prior to sampling. 10.Subjects who have participated in other clinical trials for depression treatment within the past three months. 11.Pregnant or breastfeeding women. Any subjects meeting any of the above criteria will be excluded from the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Intestinal flora;Non-targeted metabolomics; | — |
Secondary
| Measure | Time frame |
|---|---|
| Traditional physical scale;Pittsburgh sleep quality index;TCM syndrome score;Hamilton Depression Scale;Hamilton Anxiety Scale; | — |
Countries
China
Contacts
Public ContactXia Hong
Xiyuan Hospital of China Academy of Chinese Medical Science
Outcome results
None listed