Clinical trial NCT02423694: Effectiveness and Safety of Electro-acupuncture for Mild-to-moderate Perimenopausal Depression
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Perimenopause
Depression
Lead sponsor: Guangdong Provincial Hospital of Traditional Chinese Medicine
Sponsor class: OTHER
First posted: 2015-04-22
Enrollment: 252
Sex: FEMALE
Minimum age (years): 45
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Change from Baseline in scores of the 17-item Hamilton depression rating scale (HAMD-17)
timeFrame: 0 week, 4th week, 8th week, 12th week, 16th week and 24th week
Secondary outcomes:
measure: Change from Baseline in scores of the Menopause-Specific Quality of Life questionnaire (MENQOL)
timeFrame: 0 week, 4th week, 8th week, 12th week, 16th week, 20th week and 24th week
measure: Change from Baseline in level of estradiol (E2),
timeFrame: 0 week, 12th week
measure: Change from Baseline in level of follicle-stimulating hormone (FSH)
timeFrame: 0 week, 12th week
measure: Change from baseline in level of Luteinizing hormone (LH)
timeFrame: 0 week, 12th week
measure: Change from baseline in level of FSH/LH
timeFrame: 0 week, 12th week
Other outcomes:
measure: safety of electro-acupuncture as measured by safety and acceptability questionnaires
timeFrame: 0 week, 4th week, 8th week, and 12th week
measure: safety of escitalopram as measured by Asberg Rating Scale for Side Effect (SERS)
timeFrame: 0 week, 4th week, 8th week, and 12the week
measure: safety of escitalopram as measured by liver functure test
timeFrame: 0 week, 4th week, 8th week, and 12the week
measure: safety of escitalopram as measured by kidney functure test
timeFrame: 0 week, 4th week, 8th week, and 12the week
measure: safety of both groups before treatment as measured by EKG
timeFrame: 0 week
measure: safety of both groups before treatment as meausred by blood regular test
timeFrame: 0 week
measure: safety of both groups before treatment as measured by urine regular test
timeFrame: 0 week
Locations:
city: Guangzhou
country: China
facility: Guangdong Provincial Hospital of Traditional Chinese Medicine
state: Guangdong
Study officials:
affiliation: Guangdong Provincial Hospital of Traditional Chinese Medicine
name: Wenbin Fu, MD
role: STUDY_CHAIR
References:
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.