Effects of Electroacupuncture With Different Frequencies for Major Depressive Disorder

• Sponsor: Zhejiang Chinese Medical University (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05144880
• Collaborator: (none)
• Enrollment: 110
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 25.9
• Patients Per Site Per Month: 4.2

Study Details

Study Description

Brief Summary

Two groups of subjects will be included 55 subjects in electroacupuncture with 2Hz group, 55 subjects in the electroacupuncture with 100Hz group. The clinical efficacy of electroacupuncture with different frequencies (2 Hz, 100 Hz) in the treatment of MDD will be observed by evaluation indicators, such as Self-rating depression scale and Hamilton depression scale.

Condition or Disease	Intervention/Treatment	Phase
Major Depressive Disorder	Other: electroacupuncture	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 110 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Effects of Electroacupuncture With Different Frequencies for Major Depressive Disorder
• Actual Study Start Date: Nov 1, 2021
• Anticipated Primary Completion Date: Dec 30, 2023
• Anticipated Study Completion Date: Dec 30, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: electroacupuncture with 2Hz group	Other: electroacupuncture; A total of 12 treatment sessions will be administered to each participant. The acupoints of needles inserted for each participant in each session are DU20, EX-HN1, DU29, HT17, PC6, RN6, RN4, LR3 and SP6. The needles will be manually stimulated by rotating, thrusting, stirring, etc. to produce ''De Qi'' sensation. Then we will use electroacupuncture for acupoint stimulation lasting 30min. The frequency will be set as 2Hz for the electroacupuncture with 2Hz group and the frequency will be set as 100Hz for the electroacupuncture with 100Hz group.
Experimental: electroacupuncture with 100Hz group	Other: electroacupuncture; A total of 12 treatment sessions will be administered to each participant. The acupoints of needles inserted for each participant in each session are DU20, EX-HN1, DU29, HT17, PC6, RN6, RN4, LR3 and SP6. The needles will be manually stimulated by rotating, thrusting, stirring, etc. to produce ''De Qi'' sensation. Then we will use electroacupuncture for acupoint stimulation lasting 30min. The frequency will be set as 2Hz for the electroacupuncture with 2Hz group and the frequency will be set as 100Hz for the electroacupuncture with 100Hz group.

Outcome Measures

Primary Outcome Measures

1. Change in anxiety and depression severity measure by Self-rating depression scale（SDS） [There will be evaluated before intervention, at 2, 4weeks after intervention and at the end of 4-weeks follow-up.]

   This scale contains 20 items that reflect the subjective feelings of depression, 10 of which are positive scores and 10 are reverse scores. Each item is divided into four grades according to the frequency of symptoms, If it is a positive scoring question, it will be rated as 1, 2, 3, and 4 points; for a reverse scoring question, it will be rated as 4, 3, 2, and 1. After the evaluation, add up the scores in the 20 items to get the total rough score, and then multiply the rough score by 1.25 and take the integer part to get the standard score

2. Change in the severity of depression measure by Hamilton depression scale (HAMD) [There will be evaluated before intervention, at 2, 4weeks after intervention and at the end of 4-weeks follow-up.]

   This scale is performed by two trained raters to perform a HAMD, usually in the form of conversation and observation. After the examination, the two raters will score independently

Secondary Outcome Measures

1. Change in sleep quality measured by Insomnia severity index (ISI) [There will be evaluated before intervention, at 2, 4weeks after intervention and at the end of 4-weeks follow-up.]

2. Change in Traditional Chinese medicine syndrome score [There will be evaluated before intervention, at 2, 4weeks after intervention and at the end of 4-weeks follow-up.]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 60 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

1. Patients suffering from MDD in accordance with the diagnostic criteria;

2. Hamilton Depression Scale score is between 21 and 35 (mild to moderate MDD);

3. 18≤age≤60 years, both gender;

4. Patients who have not used antidepressants and other psychiatric drugs (including traditional Chinese medicine), or have used them but have stopped for at least 2 weeks;

5. Patients have clear consciousness and could communicate with others normally;

6. Patients could understand the full study protocol and written informed consent is provided by themselves. Note: Subjects who meet the above six items will be included.

Exclusion Criteria:

1. Patients with bipolar disorder;

2. Patients with schizophrenia or other mental disorders;

3. Patients with severe medical diseases, tumors or diseases of the central nervous system;

4. Patients suffering from severe depressive episode with psychotic symptoms;

5. Suicidal patients;

6. Patients with seasonal depression;

7. Patients with organic depression;

8. Patients with alcohol or drug addicts;

9. Patients using other therapies;

10. Patients in pregnancy or lactation;

11. Patients suffering from cognitive dysfunction, aphasia or other diseases that cannot cooperate with treatment;

12. Patients with pacemakers;

13. Patients who are not suitable for electroacupuncture.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Xiaoyu Li	Hangzhou	Zhejiang	China	310053

Sponsors and Collaborators

• Zhejiang Chinese Medical University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Xiaoyu Li, Attending Doctor, Zhejiang Chinese Medical University
• ClinicalTrials.gov Identifier: NCT05144880
• Other Study ID Numbers: 2020YKJ08
• First Posted: Dec 3, 2021
• Last Update Posted: Dec 3, 2021
• Last Verified: Dec 1, 2021

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major

Study Results

No Results Posted as of Dec 3, 2021