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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Electroacupuncture | Experimental | 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. |
|
| escitalopram oxalate tablets | Active Comparator | 0.5 hour after breakfast oral taking 10mg escitalopram oxalate tablets, continuous treatment for 12 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| electro-acupuncture | Device | 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 |
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| safety of electro-acupuncture as measured by safety and acceptability questionnaires | safety and acceptability | 0 week, 4th week, 8th week, and 12th week |
| safety of escitalopram as measured by Asberg Rating Scale for Side Effect (SERS) |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Wenbin Fu, MD | Contact | fuwenbin@139.com | ||
| Zhaofeng Li | Contact | qdlzfcmd@126.com |
| Name | Affiliation | Role |
|---|---|---|
| Wenbin Fu, MD | Guangdong Provincial Hospital of Traditional Chinese Medicine | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Guangdong Provincial Hospital of Traditional Chinese Medicine | Recruiting | Guangzhou | Guangdong | 510120 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30003102 | Derived | Li S, Li ZF, Wu Q, Guo XC, Xu ZH, Li XB, Chen R, Zhou DY, Wang C, Duan Q, Sun J, Luo D, Li MY, Wang JL, Xie H, Xuan LH, Su SY, Huang DM, Liu ZS, Fu WB. A Multicenter, Randomized, Controlled Trial of Electroacupuncture for Perimenopause Women with Mild-Moderate Depression. Biomed Res Int. 2018 May 29;2018:5351210. doi: 10.1155/2018/5351210. eCollection 2018. |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Aug 10, 2017 | |
| Reset | Feb 20, 2018 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Aug 10, 2017 | Feb 20, 2018 |
| ID | Term |
|---|---|
| D003863 | Depression |
| ID | Term |
|---|---|
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D000089983 | Escitalopram |
| ID | Term |
|---|---|
| D011437 | Propylamines |
| D000588 | Amines |
| D009930 | Organic Chemicals |
| D009570 | Nitriles |
| D001572 |
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|
| escitalopram oxalate tablets | Drug | escitalopram oxalate tablet, once a day, 0.5 hour after breakfast, oral taken, 10mg, for 12 weeks |
|
| 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 |
Asberg Rating Scale for Side Effect (SERS)
| 0 week, 4th week, 8th week, and 12the week |
| safety of escitalopram as measured by liver functure test | ALT, aspartate transminase (AST), and TBIL | 0 week, 4th week, 8th week, and 12the week |
| safety of escitalopram as measured by kidney functure test | Cr, BUN | 0 week, 4th week, 8th week, and 12the week |
| safety of both groups before treatment as measured by EKG | EKG | 0 week |
| safety of both groups before treatment as meausred by blood regular test | Blood regular test | 0 week |
| safety of both groups before treatment as measured by urine regular test | Urine regular test | 0 week |
| Benzofurans |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |