NCT02423694

Brief 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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
252

participants targeted

Target at P75+ for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2013

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

April 11, 2015

Completed
11 days until next milestone

First Posted

Study publicly available on registry

April 22, 2015

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
Last Updated

April 22, 2015

Status Verified

April 1, 2015

Enrollment Period

2.2 years

First QC Date

April 11, 2015

Last Update Submit

April 19, 2015

Conditions

PerimenopauseDepression

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (5)

  • 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

Other Outcomes (7)

  • safety of electro-acupuncture as measured by safety and acceptability questionnaires

    0 week, 4th week, 8th week, and 12th week

  • safety of escitalopram as measured by 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

    0 week, 4th week, 8th week, and 12the week

  • +4 more other outcomes

Study Arms (2)

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.

Device: electro-acupuncture

escitalopram oxalate tablets

ACTIVE COMPARATOR

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

Drug: escitalopram oxalate tablets

Interventions

electro-acupunctureDEVICE

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

Electroacupuncture
escitalopram oxalate tabletsDRUG

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

escitalopram oxalate tablets

Eligibility Criteria

Age45 Years - 55 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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;
  • +7 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Guangdong Provincial Hospital of Traditional Chinese Medicine

Guangzhou, Guangdong, 510120, China

RECRUITING

Related Publications (1)

  • 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.

    PMID: 30003102DERIVED

MeSH Terms

Conditions

Depression

Interventions

Escitalopram

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehavior

Intervention Hierarchy (Ancestors)

PropylaminesAminesOrganic ChemicalsNitrilesBenzofuransHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • Wenbin Fu, MD

    Guangdong Provincial Hospital of Traditional Chinese Medicine

    STUDY CHAIR

Central Study Contacts

Wenbin Fu, MD

CONTACT

fuwenbin@139.com

Zhaofeng Li

CONTACT

qdlzfcmd@126.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

April 11, 2015

First Posted

April 22, 2015

Study Start

September 1, 2013

Primary Completion

December 1, 2015

Last Updated

April 22, 2015

Record last verified: 2015-04

Locations

CN(1)