Effectiveness and Safety of Electro-acupuncture for Mild-to-moderate Perimenopausal Depression

Study Overview
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Brief Summary
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Main objective: to compare the effects of electro-acupuncture and escitalopram oxalate tablets on mild-to-moderate perimenopausal depression, and to evaluate the safety of electroacupuncture stimulation.

Conditions
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Perimenopause, Depression

Intervention / Treatment
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* Device: electro-acupuncture
* Drug: escitalopram oxalate tablets


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Conforms to the diagnosis standard of STRAW-10 for perimenopause, conforms to the diagnosis standard of The Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) for depression, and conforms to the diagnosis standard of The International Statistical Classification of Diseases and Related Health Problems 10th Revision (ICD-10) F32.0(mild depression) or F32.1(moderate depression); Fisrt attack during perimenopausal period; HAMD-17 score >7 and <23; Age ≥45 to ≤55; No hormone replacement therapy (HRT) or no antidepressant 3 months before into the group; Sign the consent consent, volunteered for this study Exclusion Criteria: Fail to rule out the possibility of suicide in depression factor of The Symptom Checklist (SCL-90); Application of estrogen, progesterone, selective serotonin reuptake inhibitors (SSRIs), soybean isoflavone, vitamin E or black cohosh in recent 4 weeks; Allergic to citalopram or escitalopram tablets; Taken the non selective, irreversible inhibitor of monoamine oxidase (MAOIs) in recent 2 weeks; Taken linezolid, pimozide, tryptophane,tramadol, triptans or other drugs that may cause drug adverse reactions in recent 2 weeks; Patient with prolongation of the QT interval or congenital long QT syndrome Taken herbs or products that contain isatin, pilose antler, hawthorn, fleeceflower root, common St.John's wort herb, hypericin; Ovarian dropsy or hysteromyoma with more than 4cm diameter, oophorectomy, or hysterectomy; Mandatory indications of hormonotherapy, such as surgery-induced menopause or osteoporosis; Patient with history of radiotherapy or chemotherapy, or undergoing radiotherapy or chemotherapy; Vaginal bleeding of undetermined origin; Patient with coagulation disorders, or taking anticoagulants such as Warfarin, or heparin; Patient with skin diseases, such as eczema,or psoriasis; Serious hepatic insufficiency or serious renal inadequacy; Uncontrolled hypertension, diabetes, or thyroid disease; Diabetic neuropathy, or malignant tumor; Pregnancy intention, in pregnancy or lactation; Regular use of sedative and anti anxiety drugs; The long-term smoking and/or drinking; Having Pacemaker or artificial joint； Electrolyte is disorder, serious heart disease or other potential life-threatening disease patients; Compliance may be poor or fear of acupuncture.

Ages Eligible for Study
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Minimum Age: 45 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Electroacupuncture<br>Baihui, Yintang, Guanyuan(dual), Zigong(dual), Sanyinjiao(dual), Hegu(dual), Taichong(dual). Insert needles to the acupoints mentioned above after sterilized.Needle handles of Baihui and Yintang are connected with the electroacupuncture instrument wire. And needle handles of bilateral Zigong are conneted with the electroacupunture instrument wire. And needle handles of bilateral Tianshu are connected with the electroacupunture instrument wire. Density wave, frequency of 10/50Hz and current intensity is 0.5 1.0 mA for 30 minutes. 3 times per week. Each treatment interval of more than 24 hours, continuous treatment for 12 weeks. | Device: electro-acupuncture<br>* 8 acupoint: Guanyuan, Zigong (bilateral), Tianshu(bilateral), Sanyinjiao(bilateral), Hegu(bilateral), Taichong(bilateral), Baihui, Yintang. Every patient is supposed to have 36 times acupuncture treatment. 30 minutes per time. Baihui, Yintang, Zigong (bilateral), Tianshu (bilateral) are applied with electro-acupuncture device with dilatational wave, current frequency: 10/50Hz, intensity: 0.5 1.0 mA<br>|
| Active Comparator: escitalopram oxalate tablets<br>0.5 hour after breakfast oral taking 10mg escitalopram oxalate tablets, continuous treatment for 12 weeks. | Drug: escitalopram oxalate tablets<br>* escitalopram oxalate tablet, once a day, 0.5 hour after breakfast, oral taken, 10mg, for 12 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from Baseline in scores of the 17-item Hamilton depression rating scale (HAMD-17) |  | 0 week, 4th week, 8th week, 12th week, 16th week and 24th week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from Baseline in scores of the Menopause-Specific Quality of Life questionnaire (MENQOL) |  | 0 week, 4th week, 8th week, 12th week, 16th week, 20th week and 24th week | 
| Change from Baseline in level of estradiol (E2), |  | 0 week, 12th week | 
| Change from Baseline in level of follicle-stimulating hormone (FSH) |  | 0 week, 12th week | 
| Change from baseline in level of Luteinizing hormone (LH) |  | 0 week, 12th week | 
| Change from baseline in level of FSH/LH |  | 0 week, 12th week |