Effects of Electroacupuncture With Different Frequencies for Major Depressive Disorder

NCT05144880 | Unknown

• 1 other identifier: 2020YKJ08
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (2)

• 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

  There will be evaluated before intervention, at 2, 4weeks after intervention and at the end of 4-weeks follow-up.

• 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

  There will be evaluated before intervention, at 2, 4weeks after intervention and at the end of 4-weeks follow-up.

Secondary Outcomes (2)

• 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.

• 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.

Study Arms (2)

electroacupuncture with 2Hz group

EXPERIMENTAL

Other: electroacupuncture

electroacupuncture with 100Hz group

EXPERIMENTAL

Other: electroacupuncture

Interventions

electroacupuncture 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; electroacupuncture with 2Hz group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Patients suffering from MDD in accordance with the diagnostic criteria;
• Hamilton Depression Scale score is between 21 and 35 (mild to moderate MDD);
• ≤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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Zhejiang Chinese Medical University: lead

Study Sites (1)

Xiaoyu Li

Hangzhou, Zhejiang, 310053, China

Location

MeSH Terms

Conditions

Depressive Disorder, Major

Interventions

Electroacupuncture

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Combined Modality Therapy; Therapeutics; Acupuncture Therapy; Complementary Therapies; Electric Stimulation Therapy; Physical Therapy Modalities; Rehabilitation; Transcutaneous Electric Nerve Stimulation; Analgesia; Anesthesia and Analgesia; Anesthesia

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Attending Doctor

Study Record Dates

• First Submitted: November 14, 2021
• First Posted: December 3, 2021
• Study Start: November 1, 2021
• Primary Completion: December 30, 2023
• Study Completion: December 30, 2024
• Last Updated: January 31, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF, CSR

Locations

CN (1)