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Status unknownNCT02423694Updated Apr 22, 2015

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

An interventional study of electro-acupuncture and escitalopram oxalate tablets in Perimenopause and Depression, sponsored by Guangdong Provincial Hospital of Traditional Chinese Medicine. Status unknown at 1 site in China. Open to female participants aged 45 Years to 55 Years. Per ClinicalTrials.gov, last updated 2015-04-22.

Sponsored by Guangdong Provincial Hospital of Traditional Chinese Medicine · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Apr 2015), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
252
Allocation
Randomized
Ages
45 Years to 55 Years
Sex
Female
01

Study summary

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.

02

Conditions studied

  • Perimenopause
  • Depression
03

In context

Depression

8,057 studies on the registry are indexed under Depression; 1,643 are open to participants now.

This study's planned enrollment of 252 is above the median of 84 across 6,718 interventional studies indexed under Depression.

Browse Depression studies →

Lead sponsor

Guangdong Provincial Hospital of Traditional Chinese Medicine is the lead sponsor of 40 studies on the registry; 9 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
45 Years to 55 Years
Sexes eligible
Female
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
252 participants (estimated)

Study arms

  • Experimental
    Electroacupuncture

    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

  • Active comparator
    escitalopram oxalate tablets

    0.5 hour after breakfast oral taking 10mg escitalopram oxalate tablets, continuous treatment for 12 weeks.

    Drug: escitalopram oxalate tablets

Interventions

  • Deviceelectro-acupuncture

    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

  • Drugescitalopram oxalate tablets

    escitalopram oxalate tablet, once a day, 0.5 hour after breakfast, oral taken, 10mg, for 12 weeks

06

What researchers measure

Primary outcomes

  1. Change from Baseline in scores of the 17-item Hamilton depression rating scale (HAMD-17)

    Time frame: 0 week, 4th week, 8th week, 12th week, 16th week and 24th week

Secondary outcomes

  1. Change from Baseline in scores of the Menopause-Specific Quality of Life questionnaire (MENQOL)

    Time frame: 0 week, 4th week, 8th week, 12th week, 16th week, 20th week and 24th week

  2. Change from Baseline in level of estradiol (E2),

    Time frame: 0 week, 12th week

  3. Change from Baseline in level of follicle-stimulating hormone (FSH)

    Time frame: 0 week, 12th week

  4. Change from baseline in level of Luteinizing hormone (LH)

    Time frame: 0 week, 12th week

  5. Change from baseline in level of FSH/LH

    Time frame: 0 week, 12th week

Other outcomes

  1. safety of electro-acupuncture as measured by safety and acceptability questionnaires

    safety and acceptability

    Time frame: 0 week, 4th week, 8th week, and 12th week

  2. safety of escitalopram as measured by Asberg Rating Scale for Side Effect (SERS)

    Asberg Rating Scale for Side Effect (SERS)

    Time frame: 0 week, 4th week, 8th week, and 12the week

  3. safety of escitalopram as measured by liver functure test

    ALT, aspartate transminase (AST), and TBIL

    Time frame: 0 week, 4th week, 8th week, and 12the week

  4. safety of escitalopram as measured by kidney functure test

    Cr, BUN

    Time frame: 0 week, 4th week, 8th week, and 12the week

  5. safety of both groups before treatment as measured by EKG

    EKG

    Time frame: 0 week

  6. safety of both groups before treatment as meausred by blood regular test

    Blood regular test

    Time frame: 0 week

  7. safety of both groups before treatment as measured by urine regular test

    Urine regular test

    Time frame: 0 week

07

Study locations

1 of 1 sites recruiting
  • Guangdong Provincial Hospital of Traditional Chinese Medicine
    Guangzhou, Guangdong 510120, China
    Recruiting
08

References and documents

Publications

  • 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. PubMed 30003102 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 22, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02423694
Lead sponsor
Guangdong Provincial Hospital of Traditional Chinese Medicine
Responsible party
Fu Wenbin (Professor, Guangdong Provincial Hospital of Traditional Chinese Medicine) — Principal investigator
First posted
Apr 22, 2015
Start date
Sep 2013
Primary completion
Dec 2015 (estimated)
Last update
Apr 22, 2015

Study contacts

Wenbin Fu, MD
Contact
fuwenbin@139.com
Zhaofeng Li
Contact
qdlzfcmd@126.com
Wenbin Fu, MD
study chair · Guangdong Provincial Hospital of Traditional Chinese Medicine
View the source record on ClinicalTrials.gov ↗

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