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

Depression Clinical Trial

Clinical Trial Details — Status: Unknown status

Administrative data

• NCT number: NCT02423694
• Other study ID #: 2012BAI24B01
• Status: Unknown status
• Phase: N/A
• First received: April 11, 2015
• Last updated: April 19, 2015
• Start date: September 2013

Study information

• Verified date: April 2015
• Source: Guangdong Provincial Hospital of Traditional Chinese Medicine
• Contact: Wenbin Fu, MD
• Email: fuwenbin[@]139.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Unknown status
• Enrollment: 252
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 45 Years to 55 Years

Eligibility

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.

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Perimenopause

Intervention

Device:
• 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

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

Locations

Country	Name	City	State
China	Guangdong Provincial Hospital of Traditional Chinese Medicine	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Guangdong Provincial Hospital of Traditional Chinese Medicine

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	safety of electro-acupuncture as measured by safety and acceptability questionnaires	safety and acceptability	0 week, 4th week, 8th week, and 12th week
Other	safety of escitalopram as measured by Asberg Rating Scale for Side Effect (SERS)	Asberg Rating Scale for Side Effect (SERS)	0 week, 4th week, 8th week, and 12the week
Other	safety of escitalopram as measured by liver functure test	ALT, aspartate transminase (AST), and TBIL	0 week, 4th week, 8th week, and 12the week
Other	safety of escitalopram as measured by kidney functure test	Cr, BUN	0 week, 4th week, 8th week, and 12the week
Other	safety of both groups before treatment as measured by EKG	EKG	0 week
Other	safety of both groups before treatment as meausred by blood regular test	Blood regular test	0 week
Other	safety of both groups before treatment as measured by urine regular test	Urine regular test	0 week
Primary	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	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
Secondary	Change from Baseline in level of estradiol (E2),		0 week, 12th week
Secondary	Change from Baseline in level of follicle-stimulating hormone (FSH)		0 week, 12th week
Secondary	Change from baseline in level of Luteinizing hormone (LH)		0 week, 12th week
Secondary	Change from baseline in level of FSH/LH		0 week, 12th week