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

NCT ID: NCT02423694

Last Updated: 2015-04-22

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 252 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-09-30

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.

Conditions

Perimenopause; Depression

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

electro-acupuncture

Intervention Type: 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

escitalopram oxalate tablets

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

Group Type: ACTIVE_COMPARATOR

escitalopram oxalate tablets

Intervention Type: DRUG

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

Interventions

electro-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

Intervention Type: DEVICE

escitalopram oxalate tablets

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

Intervention Type: DRUG

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.

• Minimum Eligible Age: 45 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Guangdong Provincial Hospital of Traditional Chinese Medicine

OTHER

Sponsor Role: lead

Responsible Party

Fu Wenbin

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Wenbin Fu, MD

Role: STUDY_CHAIR

Guangdong Provincial Hospital of Traditional Chinese Medicine

Locations

Guangdong Provincial Hospital of Traditional Chinese Medicine

Guangzhou, Guangdong, China

Site Status: RECRUITING

Countries

China

Central Contacts

Wenbin Fu, MD

Role: CONTACT

fuwenbin@139.com

Zhaofeng Li

Role: CONTACT

qdlzfcmd@126.com

Facility Contacts

Wenbin Fu, MD

Role: primary

fuwenbin@139.com

Zhaofeng Li

Role: backup

qdlzfcmd@126.com

References

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.

Reference Type: DERIVED

PMID: 30003102 (View on PubMed)

Other Identifiers

2012BAI24B01

Identifier Type: -

Identifier Source: org_study_id