Back to results

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

Primary Purpose

Perimenopause, Depression

Status

Unknown status

Phase

Not Applicable

Locations

China

Study Type

Interventional

Intervention

electro-acupuncture

escitalopram oxalate tablets

About this trial

This is an interventional treatment trial for Perimenopause

Eligibility Criteria

45 Years - 55 Years (Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

Guangdong Provincial Hospital of Traditional Chinese MedicineRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Electroacupuncture

escitalopram oxalate tablets

Arm Description

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.

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Change from Baseline in level of estradiol (E2),

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

Change from baseline in level of Luteinizing hormone (LH)

Change from baseline in level of FSH/LH

Full Information

NCT ID

NCT02423694

First Posted

April 11, 2015

Last Updated

April 19, 2015

Sponsor

Guangdong Provincial Hospital of Traditional Chinese Medicine

1. Study Identification

Unique Protocol Identification Number

NCT02423694

Brief Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2015

Overall Recruitment Status

Unknown status

Study Start Date

September 2013 (undefined)

Primary Completion Date

December 2015 (Anticipated)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Guangdong Provincial Hospital of Traditional Chinese Medicine

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Perimenopause, Depression

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

252 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Electroacupuncture

Arm Type

Experimental

Arm Description

Arm Title

escitalopram oxalate tablets

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Device

Intervention Name(s)

electro-acupuncture

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

escitalopram oxalate tablets

Intervention Description

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

Primary Outcome Measure Information:

Title

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 Outcome Measure Information:

Title

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

Title

Change from Baseline in level of estradiol (E2),

Time Frame

0 week, 12th week

Title

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

Time Frame

0 week, 12th week

Title

Change from baseline in level of Luteinizing hormone (LH)

Time Frame

0 week, 12th week

Title

Change from baseline in level of FSH/LH

Time Frame

0 week, 12th week

Other Pre-specified Outcome Measures:

Title

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

Description

safety and acceptability

Time Frame

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

Title

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

Description

Asberg Rating Scale for Side Effect (SERS)

Time Frame

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

Title

safety of escitalopram as measured by liver functure test

Description

ALT, aspartate transminase (AST), and TBIL

Time Frame

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

Title

safety of escitalopram as measured by kidney functure test

Description

Cr, BUN

Time Frame

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

Title

safety of both groups before treatment as measured by EKG

Description

EKG

Time Frame

0 week

Title

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

Description

Blood regular test

Time Frame

0 week

Title

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

Description

Urine regular test

Time Frame

0 week

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

45 Years

Maximum Age & Unit of Time

55 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Wenbin Fu, MD

fuwenbin@139.com

First Name & Middle Initial & Last Name or Official Title & Degree

Zhaofeng Li

qdlzfcmd@126.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Wenbin Fu, MD

Organizational Affiliation

Guangdong Provincial Hospital of Traditional Chinese Medicine

Official's Role

Study Chair

Facility Information:

Facility Name

Guangdong Provincial Hospital of Traditional Chinese Medicine

City

Guangzhou

State/Province

Guangdong

ZIP/Postal Code

510120

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Wenbin Fu, MD

fuwenbin@139.com

First Name & Middle Initial & Last Name & Degree

Zhaofeng Li

qdlzfcmd@126.com

12. IPD Sharing Statement

Citations:

PubMed Identifier

30003102

Citation

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.

Results Reference

derived

Learn more about this trial

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

We'll reach out to this number within 24 hrs