depression
Conditions
Interventions
Jia Wei Xiao Yao San Combined Decoction Granules Group:Jia Wei Xiao Yao San Combined Decoction Granules+Escitalopram
Jia Wei Xiao Yao San Formula Granules Low Dose Group:Jia Wei Xiao Yao San Formula Granules Low Dose+Escitalopram
Jia Wei Xiao Yao San Formula Granules High Dose Group:Jia Wei Xiao Yao San Formula Granules High Dose+Escitalopram
Sponsors
The Affiliated TCM Hospital of Guangzhou Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Meet the diagnostic criteria for depressive disorders in the Diagnostic and Statistical Manual of Mental Disorders Fifth Edition (DSM-5) of the United States of America with either first episode or relapse; 2. Meet the diagnostic criteria of Liver Depression and Spleen Deficiency type in the Diagnostic and Therapeutic Criteria for Chinese Medicine Diseases; 3. Aged 18-65 (including 18 and 65 years old) gender is not limited ; 4. Meet mild (8 = 17-item Hamilton Depression Rating Scale score <14) and moderate (14 = 17-item Hamilton Depression Rating Scale score <20); 5. No suicide risk a "no" response on all items of the Suicide Severity Rating Scale (C-SSRS) and a score of <3 on item 3 (suicide) of the HAMD-17; 6. Have not been treated with antidepressants (escitalopram mirtazapine etc.) and physical therapy (acupuncture transcranial magnetic stimulation transcranial electrical stimulation electroconvulsive therapy etc.) within the previous 1 month; 7. Voluntarily participated in this study and I signed the informed consent form.
Exclusion criteria
Exclusion criteria: 1. Currently or previously suffered from a diagnosis consistent with other mental disorders in the DSM-5 such as bipolar disorder schizophrenia post-traumatic stress disorder and personality disorders; 2. Patients with severe or unstable cardiovascular respiratory hepatic renal hematologic or other systemic diseases as well as patients with acute illnesses infectious diseases or malignant tumors who in the opinion of the investigator are not suitable for enrollment in this study; 3. Presence of alcohol (or drug) dependence or abuse and tobacco addiction (more than 10 cigarettes per day); 4. Women who are pregnant or breastfeeding or who plan to become pregnant or who do not agree to use contraception; 5. Those who have participated in any other clinical study in the last 3 months.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mean difference on the 17-item Hamilton Depression Scale (HAMD-17); | — |
Secondary
| Measure | Time frame |
|---|---|
| HAMD-17 clinical reduction rate( = pre-treatment HAMD-17 score - post-treatment HAMD-17 score)/Pre-treatment HAMD-17 score;PSQI scale scores;Clinical remission rate(HAMD-17 score <7 after 8 weeks of treatment);Change in HAMA-14 scale scores; | — |
Countries
China
Contacts
Public ContactLin Yu
The Affiliated TCM Hospital of Guangzhou Medical University
Outcome results
None listed