PerimenopauseNCT02423694
Effectiveness and Safety of Electro-acupuncture for Mild-to-moderate Perimenopausal Depression
A study testing electro-acupuncture and escitalopram oxalate tablets in people with Perimenopause and Depression, run by Guangdong Provincial Hospital of Traditional Chinese Medicine at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 45 to 55 years, women only
- Conditions the study is for
- Perimenopause, Depression
- What is being tested?
- electro-acupuncture and escitalopram oxalate tablets
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 252 participants
- Where
- 1 siteChina
- Study dates
- Sep 2013to Dec 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 55 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 22Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
Wenbin Fu, MD contact
Zhaofeng Li contact
China1 site, 1 recruiting
- Recruiting
Guangdong Provincial Hospital of Traditional Chinese Medicine
Guangzhou, Guangdong, 510120
Wenbin Fu, MD, fuwenbin@139.com
Zhaofeng Li, qdlzfcmd@126.com
About this study
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
- Being tested
- electro-acupuncture, escitalopram oxalate tablets
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
escitalopram oxalate tabletsDrug
escitalopram oxalate tablet, once a day, 0.5 hour after breakfast, oral taken, 10mg, for 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: electro-acupuncture |
| escitalopram oxalate tablets | Active comparator | 0.5 hour after breakfast oral taking 10mg escitalopram oxalate tablets, continuous treatment for 12 weeks. Receives: Drug: escitalopram oxalate tablets |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline in scores of the 17-item Hamilton depression rating scale (HAMD-17)
Measured: 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)
Measured: 0 week, 4th week, 8th week, 12th week, 16th week, 20th week and 24th week
Change from Baseline in level of estradiol (E2),
Measured: 0 week, 12th week
Change from Baseline in level of follicle-stimulating hormone (FSH)
Measured: 0 week, 12th week
Change from baseline in level of Luteinizing hormone (LH)
Measured: 0 week, 12th week
Change from baseline in level of FSH/LH
Measured: 0 week, 12th week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2015 (estimated)
- Study startSep 2013
- Primary completionDec 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PerimenopauseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 252 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Guangdong Provincial Hospital of Traditional Chinese Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fu Wenbin, Guangdong Provincial Hospital of Traditional Chinese Medicine
- Investigators
- Wenbin Fu, MD, Study chair, Guangdong Provincial Hospital of Traditional Chinese Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02423694
- Sponsor's protocol ID
- 2012BAI24B01
- Status last verified
- Apr 2015
- First submitted
- 11 Apr 2015
- Last updated
- 22 Apr 2015
- Results posted
- No
Publications
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.
PubMed 30003102
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness and Safety of Electro-acupuncture for Mild-to-moderate Perimenopausal Depression
- ClinicalTrials.gov ID
- NCT02423694
- Acronym / sponsor ID
- 2012BAI24B01
- Conditions
- Perimenopause, Depression
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 252 participants (estimated)
- Lead sponsor
- Guangdong Provincial Hospital of Traditional Chinese MedicineUniversity, hospital or other
- Study start
- Sep 2013
- Primary completion
- Dec 2015 (estimated)
- First posted
- 22 Apr 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Electroacupuncture | Experimental | Device: electro-acupunctureBaihui, 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. |
| escitalopram oxalate tablets | Active comparator | Drug: escitalopram oxalate tablets0.5 hour after breakfast oral taking 10mg escitalopram oxalate tablets, continuous treatment for 12 weeks. |
Who may qualify
- Ages
- 45 to 55 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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;
Key exclusion criteria (22 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| electro-acupuncture8 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 | Device | Electroacupuncture |
| escitalopram oxalate tabletsescitalopram oxalate tablet, once a day, 0.5 hour after breakfast, oral taken, 10mg, for 12 weeks | Drug | escitalopram oxalate tablets |
Primary outcome
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
5 secondary outcomes
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
Change from Baseline in level of estradiol (E2),
Time frame: 0 week, 12th week
Change from Baseline in level of follicle-stimulating hormone (FSH)
Time frame: 0 week, 12th week
Change from baseline in level of Luteinizing hormone (LH)
Time frame: 0 week, 12th week
Change from baseline in level of FSH/LH
Time frame: 0 week, 12th week
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2015.
- Derived from this study: PubMed 30003102Li 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wenbin Fu, MD contact
Zhaofeng Li contact
Wenbin Fu, MD study chair
Guangdong Provincial Hospital of Traditional Chinese Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing electro-acupuncture and escitalopram oxalate tablets in people with Perimenopause and Depression, run by Guangdong Provincial Hospital of Traditional Chinese Medicine at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Wenbin Fu, MD (fuwenbin@139.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02423694, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Apr 2015.