Effect of Electroacupuncture on Treating the First-episode Depression
Efficacy and Safety of Electroacupuncture on Treating the First Episode of Mild to Moderate Depression
1 other identifier
interventional
204
1 country
1
Brief Summary
Depression is a disease that endangers the physical and mental health of all human beings. Only 30-40% of patients with initial episode depression are cured after treatment with antidepressants. Acupuncture is a widely recognized therapy to treat depression in clinical practice, and it can effectively relieve the depressive mood and improve related physical symtoms in patients with mild to moderate depression. This randomised controlled trial (RCT) is aimed to investigate the efficacy and safety of electroacupuncture (EA) in the treatment for patients with the first-episode of mild to moderate depression.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable depression
Started Dec 2023
Typical duration for not_applicable depression
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 15, 2023
CompletedFirst Posted
Study publicly available on registry
April 19, 2023
CompletedStudy Start
First participant enrolled
December 1, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2026
CompletedDecember 15, 2023
December 1, 2023
2.1 years
March 15, 2023
December 11, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
17-item Hamilton Depression Rating Scale (HDRS-17)
The HDRS-17 is an observer-rating questionnaire with 17 items used to assess the symptoms of patients diagnosed as suffering from depressive states. Each item is rated in 3-point or 5-point scales. A higher total score indicates a higher depression level.
Week 12
Secondary Outcomes (7)
Recovery rate of depression
Week 12
Remission rate of depression
Week 12
HDRS-17
Week 4, week 8, week 16, week 24 and week 36
Patient Health Questionnaire(PHQ-9)
Week 4, week 8, week 16, week 24 and week 36
The Medical Outcomes Study 36-Item Short Form Health Survey (SF-36)
Week 4, week 8 and week 12
- +2 more secondary outcomes
Study Arms (2)
the electroacupuncture group
EXPERIMENTALthe electroacupuncture and the placebo drug
the drug group
PLACEBO COMPARATORthe sham acupuncture and the drug Escitalopram
Interventions
The regular acupuncture treatment will be applied at the acupoints including Baihui (GV20), Yintang (GV29), Guanyuan (RN4), Qihai (RN6), bilateral ZuSanli (ST36) and bilateral SanYinjiao (SP6). After needle insertion, rotating or lifting-thrusting manipulation will be applied for 'De qi' sensation. Three pairs of electrodes of the electroacupuncture apparatus will be connected to the needles of GV20 and GV29, and bilateral ST36 and SP6 for 25 minutes, delivering a continuous wave with a frequency of 2-8Hz which is based on the tolerance of each patient. The selection of matching acupuncture points will be determined by the acupuncturist according to the patients' different syndrome patterns.
The sham acpunture treatment will be applied at the same acupoints as the EA treatment with the Streitberger placebo needles. When the blunt needle tip of the placebo needles touches the skin, the patient will get a pricking sensation, but there is no real needle inserted into the skin. The electroacupuncture apparatus will be set on the table beside the patients and two pairs of electrodes will be connected to the needles at bilateral ST36 and SP6. Acupuncturists will turn on the apparatus but all indicators will be set to '0'. Participants will be informed when needles are removed after 25 minutes. Acupuncturists will use dry cotton balls to press the skin around the acupoints when withdrawing the needles so that patients can feel the withdrawal of the 'needles'.
Escitalopram will be used as the antidepressants for relieving patients' depressive mood. The dose of the drug will be the minimum clinical starting dose of 10 mg once daily, taken orally in the morning, for a period of 3 months. During the intervention period, patients will be allowed to increase the drug dose (up to 20 mg) according to their mental status. Patients will record the details of the drug dose, duration of dosing,responses and possible side effects on a drug dairy. Pateints will receive 7 tablets of escitalopram from an independent dispencer at a set time each week. They may receive additional dose of escitalopram once again during the week if necessary and it will be recorded by the dispenser.
Placebo drugs are tablets of the same color and size as escitalopram tablets, consisting mainly of starch, and will be tested for safety before being used in the trial. The way the medication is dispensed, the details of how the medication is administered, the dosage, and the record of the drug diary are consistent with the application of the real drugs.
Eligibility Criteria
You may qualify if:
- Participants who meet the diagnostic criteria of depression according to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition.
- Participants whose HDRS-17 score is 17-25 (mild-to-moderate depression).
- Participants who suffer from depression for the first time.
- Patients who have not taken any previous antidepressants.
- Patients who are assessed as low risk for suicide.
- Participants who have not received acupuncture treatment for at least 1 year.
- Participants who voluntarily agree with the investigation and sign a written informed consent form.
You may not qualify if:
- Participants with secondary depressive disorders caused by organic diseases, medicine or psychotic disorders.
- Participants who are in the depressive episode of bipolar disorder, or suffering from dysthymia, reactive depression and depressive syndrome caused by other diseases.
- Participants who had severe organic brain diseases and other serious physical diseases.
- Participants with a history of alcohol abuse or drug dependence.
- Participants who have enrolled in other clinical trial within 1 months.
- Pregnant or lactating women.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Shanghai Mental Health Center
Shanghai, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Shifen Xu, Doctor
Shanghai Municipal Hospital of Traditioal Chinese Medicine
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 15, 2023
First Posted
April 19, 2023
Study Start
December 1, 2023
Primary Completion
December 31, 2025
Study Completion
May 1, 2026
Last Updated
December 15, 2023
Record last verified: 2023-12
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
- Time Frame
- Data requests can be submitted starting 12 months after article publication and the data will be made accessible for up to 24 months. Extensions will be considered on a case-by-case basis.
- Access Criteria
- Access to trial IPD can be requested by qualified researchers engaging in independent scientific research, and will be provided following review and approval of a research proposal and SAP and execution of a Data Sharing Agreement (DSA). For more information or to submit a request, please contact Shifen Xu.
Results will be published by the investigators in academic journals. Data obtained through this study will be provided to qualified researchers with academic interest in acupucnture treatment for depression. Data or samples shared will be coded. The IPD can be shared by sending email to the PI Shifen Xu (xu\_teacher2006@126.com) .