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Effects of Electroacupuncture With Different Frequencies for Major Depressive Disorder

Primary Purpose

Major Depressive Disorder

Status
Active
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
electroacupuncture
Sponsored by
Zhejiang Chinese Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Major Depressive Disorder

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Xiaoyu Li

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

electroacupuncture with 2Hz group

electroacupuncture with 100Hz group

Arm Description

Outcomes

Primary Outcome Measures

Change in anxiety and depression severity measure by Self-rating depression scale（SDS）
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
Change in the severity of depression measure by Hamilton depression scale (HAMD)
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

Change in sleep quality measured by Insomnia severity index (ISI)
Change in Traditional Chinese medicine syndrome score

Full Information

First Posted
November 14, 2021
Last Updated
January 27, 2023
Sponsor
Zhejiang Chinese Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT05144880
Brief Title
Effects of Electroacupuncture With Different Frequencies for Major Depressive Disorder
Official Title
Effects of Electroacupuncture With Different Frequencies for Major Depressive Disorder
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
November 1, 2021 (Actual)
Primary Completion Date
December 30, 2023 (Anticipated)
Study Completion Date
December 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Zhejiang Chinese Medical University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Major Depressive Disorder

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
110 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
electroacupuncture with 2Hz group
Arm Type
Experimental
Arm Title
electroacupuncture with 100Hz group
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
electroacupuncture
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in anxiety and depression severity measure by Self-rating depression scale（SDS）
Description
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
Time Frame
There will be evaluated before intervention, at 2, 4weeks after intervention and at the end of 4-weeks follow-up.
Title
Change in the severity of depression measure by Hamilton depression scale (HAMD)
Description
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
Time Frame
There will be evaluated before intervention, at 2, 4weeks after intervention and at the end of 4-weeks follow-up.
Secondary Outcome Measure Information:
Title
Change in sleep quality measured by Insomnia severity index (ISI)
Time Frame
There will be evaluated before intervention, at 2, 4weeks after intervention and at the end of 4-weeks follow-up.
Title
Change in Traditional Chinese medicine syndrome score
Time Frame
There will be evaluated before intervention, at 2, 4weeks after intervention and at the end of 4-weeks follow-up.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients suffering from MDD in accordance with the diagnostic criteria; Hamilton Depression Scale score is between 21 and 35 (mild to moderate MDD); 18≤age≤60 years, both gender; 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; Patients have clear consciousness and could communicate with others normally; 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: Patients with bipolar disorder; Patients with schizophrenia or other mental disorders; Patients with severe medical diseases, tumors or diseases of the central nervous system; Patients suffering from severe depressive episode with psychotic symptoms; Suicidal patients; Patients with seasonal depression; Patients with organic depression; Patients with alcohol or drug addicts; Patients using other therapies; Patients in pregnancy or lactation; Patients suffering from cognitive dysfunction, aphasia or other diseases that cannot cooperate with treatment; Patients with pacemakers; Patients who are not suitable for electroacupuncture.
Facility Information:
Facility Name
Xiaoyu Li
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310053
Country
China

12. IPD Sharing Statement

Plan to Share IPD
Yes

Learn more about this trial

Effects of Electroacupuncture With Different Frequencies for Major Depressive Disorder

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