Condition category
Mental and Behavioural Disorders
Date applied
28/04/2019
Date assigned
23/05/2019
Last edited
15/05/2019
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Postpartum (postnatal) depression can start in parents before or after the birth of a baby. It is a serious problem because it can affect bonding between the parents and baby and childcare routines. If a mother is breastfeeding, it might not be safe to take antidepressant tablets, because breast milk can contain some of the drug. There is a new drug called Zulresso that is taken through a vein using a drip. It is safe to use during breastfeeding but is expensive.
Electroacupuncture involves very fine needles being inserted into the skin at certain points and electric current being passed through them. Electroacupuncture is cheap and does not affect breastfeeding. This study aims to investigate whether electroacupuncture can help with postpartum depression symptoms.

Who can participate?
Women who have postpartum depression within one year of their baby's birth.

What does the study involve?
Participants will be randomly allocated to one of two groups. They will not know which group they are in. Both groups will receive supportive psychotherapy. One group will receive electroacupuncture twice a week for 6 weeks. The other group will have sham electroacupuncture, where the needles are not put in the correct places and the current is not turned on.

What are the possible benefits and risks of participating?
Both groups will receive treatment in the form of supportive psychotherapy. There are some potential side effects of electroacupuncture, including bleeding, bruising and pain, but these are generally mild and will stop quickly.

Where is the study run from?
China Academy of Chinese Medical Sciences (China)

When is the study starting and how long is it expected to run for?
January 2018 to January 2020.

Who is funding the study?
The Ministry of Science and Technology of the People's Republic of China

Who is the main contact?
Mrs Hong Zhao, hongzhao2005@aliyun.com

Trial website

Contact information

Type

Scientific

Primary contact

Mrs Hong Zhao

ORCID ID

Contact details

China Academy of Chinese Medical Sciences
16 Nanxiaojie
Dongzhimennei
Dongcheng District
Beijing
100700
China
13911132103
hongzhao2005@aliyun.com

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

None

Study information

Scientific title

The effect of electroacupuncture on mild to moderate postpartum depression: a randomized controlled single-blind study.

Acronym

Study hypothesis

The morbidity of mild to moderate postpartum depression is increasingly rising. However, the need of lactation prevents the use of regular oral antidepressants. The new antidepressant Zulresso (brexanolone), which has been approved by the FDA for postpartum depression, costs USD 34,000 dollars per treatment course per person. Acupuncture might offer an advantage in mild to moderate postpartum depression because it does not affect breastfeeding. However, the supporting evidence is weak. This trial is designed to provide high-level evidence regarding whether electroacupuncture is effective in relieving the symptoms of mild to moderate postpartum. We hypothesize that the effect of electroacupuncture on mild to moderate postpartum depression will be better than that of sham electroacupuncture.

Ethics approval

1. Approved 26/07/2018, Acupuncture and Moxibustion Hospital, China Academy of Chinese Medical Science (No.16, Nanxiaojie, Dongzhimennei, Beijing; +86 010-64060868; yuxc@acutimes.com), ref: 2018-05-25-3-2
2. Approved 10/09/2018, Beijing Obstetrics and Gynecology Hospital, Capital Medical University (17 Qihelou St, Dongcheng District, Beijing; +86 010-85968407; fcyylunli@163.com), ref: 2018-KY-053-01

Study design

Two-armed single-blind randomized controlled interventional trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

No participant information sheet available.

Condition

Postpartum depression

Intervention

Eligible patients will be randomly assigned into treatment group or control group using SAS software. Group assignment information will be kept in sealed envelopes. According to their group assignment, patients will receive either electroacupuncture plus supportive psychotherapy or sham electroacupuncture plus supportive psychotherapy. Both groups will receive treatment twice a week for 6 weeks, and the whole treatment course is 12 sessions.
The treatment group will receive the electroacupuncture and the selected acupoints are as follows: Ophryon (EX-HN 3), Xinshu (BL 15), Geshu (BL 17), Ganshu (BL 18), Shenshu (BL 23), Hegu (LI 4), Sanyinjiao (Sp 6), Zhongwan (CV 12) and Baihui (GV 20).
The control group will receive sham electroacupuncture. The practitioner will needle locations beside the acupoints at superficial layers and use the electroacupuncture device without current output as the sham acupuncture.

Intervention type

Other

Phase

Drug names

Primary outcome measure

Severity of depression using the first 17 answers on Hamilton Depression Rating Scale (HAM-D). The 17-HAMD will be measured by a professional psychiatrist at baseline and weeks 2, 4 and 6

Secondary outcome measures

1. Severity of depression using the Montgomery–Åsberg Depression Rating Scale (MADRS) at baseline and weeks 2, 4 and 6
2. Postpartum depression assessed using the Edinburgh Postnatal Depression Scale at baseline, weeks 2, 4 and 6 and week 10 (4 weeks after treatment end)
3. Alertness assessed using the Stanford Sleepiness Scale at baseline and weeks 2, 4 and 6
4. Maternal functional status assessed using the Barkin Index of Maternal Functioning at baseline, weeks 2, 4 and 6 and week 10 (4 weeks after treatment end)
5. Severity of depression using the first 17 answers on Hamilton Depression Rating Scale (HAM-D) at week 10 (4 weeks after treatment end)
6. Participant assessment of depression assessed using the Patient Health Questionnaire(PHQ-9) at baseline and weeks 2, 4 and 6

Overall trial start date

20/01/2018

Overall trial end date

20/01/2020

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. Diagnosed with postpartum depression according to The Diagnostic and Statistical Manual of Mental Disorders (DSM) by psychiatrists
2. Conceived naturally or artificially
3. Aged 20–50 years
4. Overall score of ≥9 on the Edinburgh Postnatal Depression Scale (EPDS)
5. Diagnosed with mild to moderate postpartum depression according to the 17-item Hamilton Depression Scale (17-HAMD)
6. Postpartum depression onset time within 1 year after delivery
7. Can accept electroacupuncture treatment and complete the prescribed course of treatment
8. Agrees to participate in the study willingly and voluntarily and signs the informed consent form

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

60

Participant exclusion criteria

1. Brain disease or mental retardation, or have difficulty understanding the contents of questionnaires or are unable to communicate effectively
2. History of epilepsy, bipolar disorder, schizophrenia or schizoaffective disorder
3. History of suicide attempts
4. Diagnosed with non-depressive psychosis by psychiatrists
5. Addicted to alcohol or drugs
6. Received antidepressant therapy within the past month
7. Hemorrhagic diseases or infectious diseases or otherwise unable to receive acupuncture therapy

Recruitment start date

01/10/2018

Recruitment end date

01/01/2019

Locations

Countries of recruitment

China

Trial participating centre

Institute of Acupuncture and Moxibustion, China Academy of Chinese Medical Sciences
16 Nanxiaojie Dongzhimennei Dongcheng District
Beijing
100700
China

Trial participating centre

Beijing Obstetrics and Gynecology Hospital
17 Qihelou St Dongcheng District
Beijing
100020
China

Trial participating centre

Shenzhen Traditional Chinese Medicine Hospital
1 Fuhua Road
Shenzhen
518033
China

Sponsor information

Organisation

China Academy of Chinese Medical Sciences

Sponsor details

16 Nanxiao St
DongZhimen
Dongcheng District
Beijing
100000
China
+86 010-64089307
kychzhen@163.com

Sponsor type

Government

Website

Funders

Funder type

Government

Funder name

Ministry of Science and Technology of the People's Republic of China

Alternative name(s)

Chinese Ministry of Science and Technology, MOST

Funding Body Type

government organisation

Funding Body Subtype

National government

Location

China

Results and Publications

Publication and dissemination plan

We tend to publish the protocol before February 2020. We plan to publish results in December 2020.

IPD sharing statement:
The datasets generated and/or analysed during the current study during this study will be included in the subsequent results publication.

Intention to publish date

30/12/2020

Participant level data

To be made available at a later date

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

09/05/2019: Trial's existence confirmed by the ethics committee of the Institute of Acupuncture, China Academy of Chinese Medical Sciences.