Major depressive disorder
Conditions
Interventions
Experimental group:Divenlafaxine succinate sustained release tablet treatment
Sponsors
The First Hospital of Shanxi Medical University
Eligibility
Sex/Gender
Female
Age
40 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Meet the diagnostic criteria for MDD in the American Diagnostic and Statistical Manual of Mental Disorders 5th Edition (DSM-5), and have a HAM-D17 score > 17; 2. Perimenopausal or postmenopausal women aged 40 years or older; 3. More than 12 months from the last menstrual cycle or within 10 menstrual cycles before screening, the length of 2 adjacent menstrual cycles varies by >= 7 days; 4. Students with primary school education or above, understand and voluntarily participate in this study, and sign the informed consent.
Exclusion criteria
Exclusion criteria: 1. The patient has current suicidal ideation/intention, or suicidal ideation and intention to perform within 3 months prior to the start of screening, or a history of suicidal behavior within 1 year prior to the start of screening. 2. Current or past comorbidities diagnosed as schizophrenia, schizoaffective disorder, delusional disorder, alcohol or substance use disorder, or bipolar disorder; 3. Patients with serious diseases or organic lesions, such as malignant tumors, serious cardiovascular and cerebrovascular diseases, Alzheimer's disease, etc.; 4. There are premature ovarian insufficiency, premature ovarian failure, polycystic ovary syndrome, unnatural menopause or menstrual changes caused by endometrial resection or hysterectomy, pregnancy or breastfeeding; 5. Participated in interventional clinical trials 3 months before screening; 6. Treatment with monoamine oxidase inhibitors within 14 days prior to screening: 7. Due to other reasons, the researcher considers it inappropriate to participate in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Changes in HAM-D17 scores from baseline after 8 weeks of treatment; | — |
Secondary
| Measure | Time frame |
|---|---|
| Clinical Clinical Global Impression Scale-Overall Progress (CGI-I) changes after 8 weeks of treatment;Changes in Clinical Global Impression Scale-Severity of Disease (CGI-S) score after 8 weeks of treatment;Improvement in HAMA, the Hamilton anxiety scale, after 8 weeks of treatment;The Kupperman Index score scale (KI) improved menopausal symptoms after 8 weeks of treatment;Sleep improvement was assessed with the Pittsburgh Sleep Quality Scale (PSQI) after 8 weeks of treatment; | — |
Countries
China
Contacts
Public ContactLIU Zhifen
The First Hospital of Shanxi Medical University
Outcome results
None listed