How does electroacupuncture improve symptoms of postpartum depression by regulating glutamate metabolism: a clinical and mechanistic study
| ISRCTN | ISRCTN98143643 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN98143643 |
- Submission date
- 11/04/2025
- Registration date
- 14/04/2025
- Last edited
- 23/04/2025
- Recruitment status
- Recruiting
- Overall study status
- Ongoing
- Condition category
- Mental and Behavioural Disorders
Plain English summary of protocol
Background and study aims
Postpartum depression (PPD) is a serious condition that affects new mothers, causing persistent low mood, anxiety, irritability, fatigue, and other symptoms. It can be more severe and long-lasting than typical postpartum emotional changes. This study aims to understand the differences in certain biological markers between PPD patients, individuals with major depressive disorder (MDD), and healthy postpartum women. It also looks at how these markers change before and after treatment in PPD patients and compares PPD patients to MDD patients after treatment.
Who can participate?
Women aged 18 - 49 years who have been diagnosed with postpartum depression or major depressive disorder according to the DSM-5, or who are healthy postpartum women.
What does the study involve?
Participants will receive electroacupuncture treatment at specific points on the body twice a week for four weeks, totaling eight sessions. This involves using a mild electrical current at acupuncture points. They will also receive usual care, which includes health education, social support, lifestyle adjustments, and psychotherapy sessions twice a week for four weeks.
What are the possible benefits and risks of participating?
The potential benefits include improvement in depressive symptoms. Possible risks include adverse reactions such as bleeding and pain from the acupuncture.
Where is the study run from?
The study is conducted at Shanghai University of Traditional Chinese Medicine, Shenzhen Hospital, and Maternal and Child Health Hospital of Luohu District, Shenzhen City (China)
When is the study starting and how long is it expected to run for?
January 2025 to January 2029
Who is funding the study?
The study is funded by the National Natural Science Foundation of China (Grant No. 8247153215).
Who is the main contact?
Prof. Hong Zhao, hongzhao2005@aliyun.com
Contact information
Public, Scientific, Principal Investigator
Shanghai University of Traditional Chinese Medicine, Shenzhen Hospital, No.16 Xiantong Road, Liantang Street, Luohu District
Shenzhen
518002
China
 ORCID ID |
0000-0001-8211-9483 |
|---|---|
| Phone | +86 (0)755 25160866 |
| hongzhao2005@aliyun.com |
Study information
| Study design | Cross-sectional observational study followed by prospective randomized controlled trial with concurrent controls |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital, Laboratory |
| Study type | Treatment |
| Participant information sheet | No participant information sheet available |
| Scientific title | Clinical efficacy and glutamate metabolism mechanism of electroacupuncture for postpartum depression patient |
| Study objectives | Study One: Investigating the similarities and differences in glutamate metabolism among women with Postpartum Depression (PPD), Major Depressive Disorder (MDD), and healthy postpartum women. Study Two: Verifying that electroacupuncture treats PPD by specific regulatory effects on glutamate metabolism. |
| Ethics approval(s) |
Approved 20/01/2025, Ethics Committee of Shenzhen Luohu District Hospital of Traditional Chinese Medicine (Shanghai University of Traditional Chinese Medicine, Shenzhen Hospital, No.16 Xiantong Road, Liantang Street, Luohu District, Shenzhen 518002, China, Shenzhen, 518002, China; +86 (0)755 82311699; lhzyykjk@163.com), ref: 2025-LHQZYYYXLL-KY-005 |
| Health condition(s) or problem(s) studied | Postpartum depression patients, major depressive disorder patients, and healthy postpartum women. |
| Intervention | This study will be conducted across two centers to investigate the differences in glutamate metabolism among women with postpartum depression (PPD), major depressive disorder (MDD), and healthy postpartum women through analysis of tongue coating, fecal, and blood samples. This study will be conducted prospectively across two centers. Participants will be randomly assigned to three groups: experimental group (electroacupuncture + usual care for PPD patients), control group 1 (usual care for PPD patients), and control group 2 (electroacupuncture + usual care for MDD patients). Randomization will be concealed using a random number table prior to group allocation. Only after enrollment will the researchers and participants be informed of the group assignments. Due to the nature of the interventions, blinding of researchers and participants during the intervention process is not feasible. However, data analysts will be blinded during data analysis. Experimental Group: Electroacupuncture + usual care for postpartum depression (PPD) patients. Control Group 1: Usual care for PPD patients. Control Group 2: Electroacupuncture + usual care for patients with major depressive disorder (MDD). *Electroacupuncture: Acupuncture points selected include Baihui (GV20), Yintang (EX-HN3), Zhongwan (CV12), Qihai (CV6), Guanyuan (CV4), and Zusanli (ST36) bilaterally. Electroacupuncture is applied to Baihui and Yintang points using a sparse-dense wave with a frequency of 2 Hz/100 Hz. The intensity is adjusted to a level that the patient can tolerate. Each session lasts for 30 minutes, twice a week, for a total of 4 weeks, resulting in 8 treatment sessions. *Usual care: Includes health education, social support, lifestyle adjustment, and psychotherapy. The intervention lasts for 4 weeks in total. Psychotherapy sessions are 45 to 60 minutes long, conducted twice a week. |
| Intervention type | Mixed |
| Primary outcome measure | Response rate after treatment. Definition of efficacy (Response): A reduction rate of ≥ 50% in the score of the 17-item Hamilton Depression Rating Scale (HAMD-17) before and after treatment is defined as effective (Response). Calculation formula for reduction rate: (Pre-treatment HAMD-17 score − Post-treatment HAMD-17 score)/Pre-treatment HAMD-17 score × 100%. |
| Secondary outcome measures | Current secondary outcome measures as of 23/04/2025: The following secondary outcome measures are assessed at pre-treatment and post-treatment: 1. Depression severity is measured using the Hamilton Depression Rating Scale, 17-item (HAMD-17) 2. Anxiety severity is measured using the Hamilton Anxiety Scale (HAMA) 3. Sleep patterns of women during the postpartum period measured using the Postpartum Sleep Quality Scale (PSQS) and the Pittsburgh Sleep Quality Index (PSQI) scale 4. Glutamate metabolism levels are measured in tongue coating and feces using 16S rRNA gene sequencing and metaproteomic analysis, in serum using enzyme-linked immunosorbent assay (ELISA), in plasma using ELISA, high-performance liquid chromatography, and targeted mass spectrometry, and in PBMCs using quantitative polymerase chain reaction Previous secondary outcome measures: 1. Depression severity is measured using the Hamilton Depression Rating Scale, 17-item (HAMD-17) at pre-treatment and post-treatment 2. Self-rated depression severity is measured using the Self-Rating Depression Scale (SDS) at pre-treatment and post-treatment 3. Anxiety severity is measured using the Hamilton Anxiety Scale (HAMA) at pre-treatment and post-treatment 4. Self-rated sleep quality is measured using the Self-Rating Scale of Sleep (SRSS) at pre-treatment and post-treatment 5. Glutamate metabolism levels are measured using tongue coating, feces, serum, plasma, and PBMC at pre-treatment and post-treatment |
| Overall study start date | 20/01/2025 |
| Completion date | 28/01/2029 |
Eligibility
| Participant type(s) | Healthy volunteer, Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 49 Years |
| Sex | Female |
| Target number of participants | 150 |
| Key inclusion criteria | 1. They meet the diagnostic criteria for postpartum depression or major depressive disorder according to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5), or they are healthy postpartum women. 2. They are females aged between 18 and 49 years. 3. They have signed the informed consent form and voluntarily agree to participate in this study. |
| Key exclusion criteria | 1. Pregnant women. 2. Alcohol dependence or dependence on addictive drugs. 3. Suicidal tendencies, with suicidal behavior within the past year. 4. Received antidepressant medication treatment within one month prior to the trial. 5. History of or current bipolar disorder, schizophrenia, organic brain disease, intellectual disability, or antisocial personality disorder. 6. Contraindications to electroacupuncture, such as severe heart disease (e.g., having a pacemaker), severe coagulation dysfunction, or skin damage and ulcers at the acupuncture sites. |
| Date of first enrolment | 24/04/2025 |
| Date of final enrolment | 31/12/2028 |
Locations
Countries of recruitment
- China
Study participating centres
Shenzhen
518002
China
Shenzhen
518019
China
Sponsor information
Government
China
Beijing
Beijing
China
| Phone | +86 10-62317474 |
|---|---|
| webmaster@nsfc.gov.cn | |
| Website | https://www.nsfc.gov.cn |
"ROR" |
https://ror.org/01h0zpd94 |
Funders
Funder type
Government
Government organisation / National government
- Alternative name(s)
- Chinese National Science Foundation, Natural Science Foundation of China, National Science Foundation of China, NNSF of China, NSF of China, 国家自然科学基金委员会, National Nature Science Foundation of China, Guójiā Zìrán Kēxué Jījīn Wěiyuánhuì, NSFC, NNSF, NNSFC
- Location
- China
Results and Publications
| Intention to publish date | 31/12/2029 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Planned publication in a peer-reviewed journal |
| IPD sharing plan | Thedatadets generated during and/or analysed during the current study will be avaible upon request from Prof. Hong Zhao, hongzhao2005@aliyun.com |
Editorial Notes
23/04/2025: The secondary outcome measures were updated, and the recruitment start date was changed from 14/04/2025 to 24/04/2025.
11/04/2025: Trial's existence confirmed by the Ethics Committee of Shenzhen Luohu District Hospital of Traditional Chinese Medicine.
