Recruiting

Efficacy and Safety of Electroacupuncture on Treating the First Episode of Mild to Moderate Depression

0 criteria met from your profileSee at a glance how your profile meets each eligibility criteria.
What is being tested

electroacupuncture (EA) treatment

+ Placebo

+ sham acupuncture (SA) treatment

OtherDrug
Who is being recruted

Behavior

+ Behavioral Symptoms

+ Depression

From 18 to 60 Years
+13 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Placebo-Controlled
Interventional
Study Start: December 2023
See protocol details

Summary

Principal SponsorShanghai Municipal Hospital of Traditional Chinese Medicine
Study ContactShifen Xu, DoctorMore contacts
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: December 1, 2023

Actual date on which the first participant was enrolled.

Patients will be recruited from the outpatient clinics in Shanghai Municipal Hospital and Shanghai Mental Health Center by Wechat and posters. A total of 204 eligible patients will be randomly allocated to two groups by a randomized block design: the electroacupuncture (EA) group (receiving EA treatment and taking the placebo drugs), and the antidepressants group (receiving sham acupuncture and taking the escitalopram ). After a one-week baseline evalauation, participants will enter a 9-month observation period in this trial, with a 3-month intervention period and a 6-month follow-up period. The interventiuon period will last for 12 weeks, with 3 sessions of real or sham acupuncture treatment per week for the first 8 weeks, and 2 sessions per week for the remaining 4 weeks. The escitalopram or the placebo will be given to the patients at a set time once a week during the 12-week intervention period, with daily oral dose of 10mg or up to 20mg as the maximum dose. Excperts in the Shanghai Mental Health Center will help the participants to adjust the drug dosage during the intervention period. The primary outcome is the 17-item Hamilton Rating Depression Sclae (HRDS-17) at week 12. The secondary outcomes include the recovery rate and the remission rate of depression, the Patient Health Questionnaire(PHQ-9) and the Medical Outcomes Study 36-Item Short Form (SF-36). Adverse effects will be assessed by the Treatment Emergent Symptom Scale through the trial. The software SPSS Version 24.0 for Windows will be used to do the data analysis. All statistical analyses will be based on the intention-to-treat (ITT) population of all randomly assigned patients, with a 2-sided significance level of less than 0.05.

Official TitleEfficacy and Safety of Electroacupuncture on Treating the First Episode of Mild to Moderate Depression
NCT05818735
Principal SponsorShanghai Municipal Hospital of Traditional Chinese Medicine
Study ContactShifen Xu, DoctorMore contacts
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

204 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 60 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

BehaviorBehavioral SymptomsDepression

Criteria

7 inclusion criteria required to participate
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.

Show More Criteria

6 exclusion criteria prevent from participating
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.

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

50% chance of being blinded to the placebo group

Treatment Groups

Group I

Experimental
the electroacupuncture and the placebo drug

Group II

Placebo
the sham acupuncture and the drug Escitalopram

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Recruiting

Shanghai Mental Health Center

Shanghai, ChinaOpen Shanghai Mental Health Center in Google Maps
Recruiting
One Study Center