Mild to Moderate Depression
Conditions
Interventions
Sponsors
Jinan University, School of Chinese Medicine
Eligibility
Sex/Gender
All
Age
16 Years to 65 Years
Inclusion criteria
Inclusion criteria: (1) Meet the diagnostic criteria for depression in the Diagnostic and Statistical Manual of Mental Disorders (DSM-5) with a HAMD-17 score between 7 and 24 points. (2) Meet the diagnosis criteria for liver depression and spleen deficiency syndrome; (3) Patients aged 16-65, regardless of gender; (4) Patients are voluntary, have informed consent, and have good compliance.
Exclusion criteria
Exclusion criteria: (1) Patients with bipolar depression, refractory depression, or suicidal tendency (item 3 score of HAMD scale > 2 points); (2) Patients with other mental disorders such as organic mental disorders, schizophrenia, depression disorders caused by psychoactive substances and non-addictive substances; (3) Patients with severe organ lesions such as heart, liver and kidney, hematological diseases or tumors; (4) Patients who have received systematic treatment within 2 weeks before enrollment; (5) Pregnant or lactating women, or those who require fertility during the trial; (6) Patients who are participating in other clinical trials or have participated in other drug clinical trials within 3 months before screening; (7) Patients with a known or suspected allergy to the investigational drugs and excipients, or hypersensitivity constitution (defined as allergy to at least 2 drugs); (8) Patients with positive hepatitis B surface antigen (HBsAg) suggested by infectious disease screening during screening period; (9) Patients who used fluoxetine within 4 weeks before enrollment; (10) Other situations that the researchers consider unsuitable for participating in this trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| HAMD(Hamilton Depression Scale); | — |
Secondary
| Measure | Time frame |
|---|---|
| HAMA(Hamilton Anxiety Scale);PSQI(Pittsburgh sleep quality index);PHQ-15(Patient Health Questionnaire-15);Syndrome score of liver depression and spleen deficiency syndrome;CGI(Clinical Global Impressions Scale);DARS(Dimentional Anhedonia Rating Scale);TEPS(Temporal Experience of Pleasure Scale);Q-LES-Q(Quality of Life Enjoyment and Satisfaction Questionnaire-Short Form); | — |
Countries
China
Contacts
Public ContactCHEN Jiaxu
Jinan University, School of Chinese Medicine
Outcome results
None listed