Female depression
Conditions
Interventions
Experimental group:Xiangshao Granules + any SSRI
On the basis of control group, Xiangshao granules, Xiangshao granules, 1 bag/time, 4 g/bag, 3 times/d, 30 min after meals, continuous treatment for 8 weeks.
Control group:Any of the SSris (e.g., Escitalopram, citalopram, fluoxetine, paroxetine, Sertraline, fluvoxamine)
Escitalopram, once daily, 10-20 mg daily
Or citalopram, once daily, 20-60 mg daily
Fluoxetine, once daily, 20 mg daily
Or paroxetine, once daily, 20-50 mg daily
Or Sertraline, once daily, 50-200 mg daily
Or fluvoxamine, once daily, 50-300 mg daily
Treatment course: Continuous treatment for 8 weeks.
Sponsors
The Second Xiangya Hospital of Central South University
Eligibility
Sex/Gender
Female
Age
18 Years to 60 Years
Inclusion criteria
Inclusion criteria: Inclusion criteria: Subjects must also meet all of the following criteria: 1. Female subjects; 2. Outpatient or inpatient patients aged 18-60 years; 3. The diagnosis of depression is consistent with DSM-5 (Diagnostic Statistical Manual of Mental Disorders 5th Edition); 4. Hamilton 24-item Depression Scale (HAMD) score >= 21 points; 5. No antidepressant has been used in the last two weeks (including no fluoxetine in the last six weeks); 6. Primary school education level or above, able to understand informed consent and assessment scale content; 7. Subjects voluntarily joined the study and signed informed consent.
Exclusion criteria
Exclusion criteria: Exclusion criteria: Exclude subjects who meet any of the following criteria: 1. Previous history of alcohol and drug abuse; 2. Patients with diabetes, epilepsy, malignant tumor, or severe hepatic and renal insufficiency; 3. Meet the diagnostic criteria for other major mental disorders in DSM-5, such as bipolar disorder, schizophrenia, anxiety disorder, etc.; 4. Present high risk of suicide (24-HAMD item 3 score >= 3); 5. Pregnant and lactating women and patients who could not take appropriate contraceptive measures during the study period and within 3 months after the last dose; 6. Patients with menorrhagia. According to the Guidelines for Clinical Research of New Chinese Medicines, menorrhagia: the menstrual cycle is basically normal, but the amount of menstruation is significantly increased than before, or the amount of menstruation is more than 100ml for more than two consecutive menstrual cycles; 7. Allergic to the study drug; 8. Currently participating in clinical trials of other drugs or medical devices; 9. Those not considered suitable for inclusion by researchers.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Hamilton Depression Scale-24 (HAMD-24); | — |
Secondary
| Measure | Time frame |
|---|---|
| Patient Health Questionnaire (PHQ-9);Baker Suicide Ideation Scale Chinese (BSI-CV) score;Hamilton Anxiety Scale (HAMA);Pittsburgh Sleep Quality Index Scale (PSQI);Gastrointestinal Symptom Grading Scale (GSRS);Sheehan Disability Rating Scale (SDS);General Clinical Efficacy Rating Scale (CGI-SI);Hamilton Depression Scale (HAMD) for Different Syndrome Differentiation and Classification of Depression; | — |
Countries
China
Contacts
Public ContactLingjiang LI
The Second Xiangya Hospital of Central South University
Outcome results
None listed