Effects of Electroacupuncture With Different Frequencies for Major Depressive Disorder

NCT ID: NCT05144880

Last Updated: 2023-01-31

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 110 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-11-01
• Study Completion Date: 2024-12-30

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.

Conditions

Major Depressive Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

electroacupuncture with 2Hz group

Group Type: EXPERIMENTAL

electroacupuncture

Intervention Type: OTHER

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.

electroacupuncture with 100Hz group

Group Type: EXPERIMENTAL

electroacupuncture

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Zhejiang Chinese Medical University

OTHER_GOV

Sponsor Role: lead

Responsible Party

Xiaoyu Li

Attending Doctor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Xiaoyu Li

Hangzhou, Zhejiang, China

Countries

China

Other Identifiers

2020YKJ08

Identifier Type: -

Identifier Source: org_study_id