Effect of Electroacupuncture on Treating the First-episode Depression

Not Applicable

Recruiting

• Conditions: Depression
• Interventions: Other: electroacupuncture (EA) treatment; Other: sham acupuncture (SA) treatment; Drug: Escitalopram 10mg; Drug: Placebo

• Registration Number: NCT05818735
• Lead Sponsor: Shanghai Municipal Hospital of Traditional Chinese Medicine

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.

Detailed Description

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.

Study Timeline

• Study First Submitted: 2023-03-15
• Study First Submitted QC: 2023-04-17
• Study First Posted: 2023-04-19
• Status Verified: 2023-12
• Study Start: 2023-12-01
• Last Update Submitted: 2023-12-11
• Last Update Posted: 2023-12-15
• Primary Completion: 2025-12-31
• Study Completion: 2026-05-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 204

Inclusion Criteria

1. Participants who meet the diagnostic criteria of depression according to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition.
2. Participants whose HDRS-17 score is 17-25 (mild-to-moderate depression).
3. Participants who suffer from depression for the first time.
4. Patients who have not taken any previous antidepressants.
5. Patients who are assessed as low risk for suicide.
6. Participants who have not received acupuncture treatment for at least 1 year.
7. Participants who voluntarily agree with the investigation and sign a written informed consent form.

Exclusion Criteria

1. Participants with secondary depressive disorders caused by organic diseases, medicine or psychotic disorders.
2. Participants who are in the depressive episode of bipolar disorder, or suffering from dysthymia, reactive depression and depressive syndrome caused by other diseases.
3. Participants who had severe organic brain diseases and other serious physical diseases.
4. Participants with a history of alcohol abuse or drug dependence.
5. Participants who have enrolled in other clinical trial within 1 months.
6. Pregnant or lactating women.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
the drug group	Escitalopram 10mg	the sham acupuncture and the drug Escitalopram
the electroacupuncture group	electroacupuncture (EA) treatment	the electroacupuncture and the placebo drug
the drug group	sham acupuncture (SA) treatment	the sham acupuncture and the drug Escitalopram
the electroacupuncture group	Placebo	the electroacupuncture and the placebo drug

Primary Outcome Measures

Name	Time	Method
17-item Hamilton Depression Rating Scale (HDRS-17)	Week 12	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.

Secondary Outcome Measures

Name	Time	Method
Recovery rate of depression	Week 12	the percentage of patients with an HDRS-17 score ≤8
HDRS-17	Week 4, week 8, week 16, week 24 and week 36	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.
The Medical Outcomes Study 36-Item Short Form Health Survey (SF-36)	Week 4, week 8 and week 12	It is one of the most widely used quality-of-life assessment scales with good reliability and validity. It provides a comprehensive overview of the participants' level of quality of life in eight dimensions: physiological functioning, physical functioning, somatic pain, general health status, energy, social functioning, emotional functioning, and mental health. A combination of item response(s) is then aggregated to calculate a score for each of the eight dimensions. The scores for each dimension range from 0 to 100, with higher scores indicating better health status.
Drug dairy	Up to 12 weeks	A drug record booklet will be issued by the study staff to each patients, and the participants will be asked to record the actual dose, frequency, time of taking drug or side effects everyday.
Adverse events（AEs）	Up to 12 weeks	Adverse events (AEs) in the trial includes any abnormal events and all types of medical events that were clearly or suspected to be related to the real and sham acupuncture treatment or the drug. Patients may occur focal skin infections, subcutaneous hematomas, and dizziness during the acupuncture treatment, or exacerbation of the condition due to excessive treatment stimulation. AEs including sedation, dizziness, sleep disorders, or constipation due to the drug will be recorded as well. Cold, trauma, or other medical events that resulted in hospitalization during the trial will be also included as AEs.
Remission rate of depression	Week 12	the percentage of patients' HDRS-17 score between 8 and 12
Patient Health Questionnaire(PHQ-9)	Week 4, week 8, week 16, week 24 and week 36	The PHQ-9 is developed according to the American Diagnostic Criteria for Major Depressive Disorder and is recommended by the WHO as an important tool for screening and assessing the depressive status of patients. It consists of 9 items that are easily and effectively used to understand a subject's depression. The higher the total score indicates the more severe depression.

Trial Locations

Locations (1)

Shanghai Mental Health Center; 🇨🇳 Shanghai, China