Mild to Moderate Depression
Conditions
Interventions
Placebo control group:Placebo(Xiaoyao mixture simulant)
Sponsors
Jinan University
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 |
|---|---|
| CGI(Clinical Global Impressions Scale);PHQ-15(Patient Health Questionnaire-15);DARS(Dimentional Anhedonia Rating Scale);Q-LES-Q(Quality of Life Enjoyment and Satisfaction Questionnaire-Short Form);HAMA(Hamilton Anxiety Scale);Syndrome score of liver depression and spleen deficiency syndrome;TEPS(Temporal Experience of Pleasure Scale);PSQI(Pittsburgh sleep quality index); | — |
Countries
China
Contacts
Public ContactCHEN Jiaxu
Jinan University
Outcome results
None listed