Back to results

Acupuncture for Patients With Major Depressive Disorder

Primary Purpose

Major Depressive Disorder

Status

Unknown status

Phase

Not Applicable

Locations

Study Type

Interventional

Intervention

acupuncture

About this trial

This is an interventional treatment trial for Major Depressive Disorder focused on measuring acupuncture, major depressive disorder, randomized controlled trial

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

Right-handed participants aged between 18 to 60 years;
participants diagnosed with mild to moderate major depressive disorder(MDD), and meet the diagnostic criteria of mild to moderate MDD according to the Diagnostic and Statistical Manual of Mental Disorders (Fifth Edition (DSM-5);
participants with score of HAMD-24 between 8 to 35;
participants without anti-depressive medication more than 3 months;
participants willing to comply with the study protocol;
participants willing to sign informed consent form.

Exclusion Criteria:

participants with severe medical visceral condition and chronic diseases, such as hypertension, coronary heart disease, hyperthyroidism, hypothyroidism or diabetes and other endocrine system diseases;
participants with brain organic diseases: such as birth injury, trauma, encephalitis, tumor, etc.;
participants with Peripheral nerve and muscular system diseases;
participants with severe anxiety, obsessive-compulsive disorder, or a history of mania or hypomania;
Recently taken drugs that may cause mood disorders;
Severe bleeding tendency, allergic constitution and skin disease patients;
pregnant or lactation women;
Persons with visual and hearing disabilities;
Participants with pacemakers, deep brain stimulators, vagus nerve stimulators, metal internal fixators, etc
participate in other clinical trials at the same time

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Sham Comparator

No Intervention

Arm Label

acupuncture

sham acupuncture

waiting-list

Arm Description

5 sessions of acupuncture per week for 4 weeks. In each session, acupuncture will be applied bilaterally on acupoints. We will use transcutaneous electric acupoints stimulation (HANS; Han's acupoints nerve stimulator, HANS-200, Nanjing, China) to stimulate the acupoints. Each session will last 30 minutes.

5 sessions of sham acupuncture per week for 4 weeks. In each session, acupuncture will be applied bilaterally on non-acupoints. We will use transcutaneous electric acupoints stimulation (HANS; Han's acupoints nerve stimulator, HANS-200, Nanjing, China) to stimulate the non-acupoints. Each session will last 30 minutes.

Outcomes

Primary Outcome Measures

score of Hamilton Depression Rating Scale-24

Reduction in the severity of depression, measured at the end of the intervention primarily as a continuous variable on the Hamilton Depression Rating Scale (HAMD)-24

Secondary Outcome Measures

score of self-rating depression scale

Reduction in the severity of depression, measured at the end of the intervention primarily as a continuous variable on self-rating depression scale (SDS)

score of Hamilton Anxiety Rating Scale

Reduction in the severity of depression, measured at the end of the intervention primarily as a continuous variable on Hamilton Anxiety Rating Scale (HAMA)

score of Social Disability Screening Schedule

change of score of Social Disability Screening Schedule (SDSS)

score of Pittsburgh sleep quality index (PSQI)

change of score of Pittsburgh sleep quality index (PSQI)

motor threshold (MT)

motor threshold (MT) measured by Brain Ultimate Combined with MEB-2312 EMG/evoked potentiometer

Intra-cortical facilitation (ICF)

Intra-cortical facilitation (ICF) measured by Brain Ultimate Combined with MEB-2312 EMG/evoked potentiometer

cortical resting period (CSP)

cortical resting period (CSP) measured by Brain Ultimate Combined with MEB-2312 EMG/evoked potentiometer [Time Frame: baseline, after intervention(4 week), after follow-up(4 week)]

intra-cortical inhibition (ICI)

intra-cortical inhibition (ICI) measured by Brain Ultimate Combined with MEB-2312 EMG/evoked potentiometer

IAPS Evoked Event-related Potentials (ERP)

Evoked Event-related Potentials (ERP) in TMS-EEG

Adverse events

Full Information

NCT ID

NCT05106868

First Posted

October 25, 2021

Last Updated

October 25, 2021

Sponsor

Chengdu University of Traditional Chinese Medicine

1. Study Identification

Unique Protocol Identification Number

NCT05106868

Brief Title

Acupuncture for Patients With Major Depressive Disorder

Official Title

Acupuncture for Patients With Major Depressive Disorder: Study Protocol of a Randomized Controlled Trial

Study Type

Interventional

2. Study Status

Record Verification Date

October 2021

Overall Recruitment Status

Unknown status

Study Start Date

November 1, 2021 (Anticipated)

Primary Completion Date

December 30, 2022 (Anticipated)

Study Completion Date

June 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Chengdu University of Traditional Chinese Medicine

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

Several studies investigating acupuncture for major depressive disorder (MDD) have been carried out. However, investigators found the results were in high heterogeneity and poor methodological quality. Thus, investigators intend to provide high quality of the effectiveness and safety of acupuncture for MDD.

6. Conditions and Keywords

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

Major Depressive Disorder

Keywords

acupuncture, major depressive disorder, randomized controlled trial

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

123 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

acupuncture

Arm Type

Experimental

Arm Description

Arm Title

sham acupuncture

Arm Type

Sham Comparator

Arm Description

Arm Title

waiting-list

Arm Type

No Intervention

Intervention Type

Device

Intervention Name(s)

acupuncture

Intervention Description

Acupuncture is a form of alternative medicine and a component of traditional Chinese medicine (TCM) in which thin needles are inserted into the acupoints on body to treat diseases.

Primary Outcome Measure Information:

Title

score of Hamilton Depression Rating Scale-24

Description

Reduction in the severity of depression, measured at the end of the intervention primarily as a continuous variable on the Hamilton Depression Rating Scale (HAMD)-24

Time Frame

change from baseline to 4 weeks after intervention, after follow-up(4 week)

Secondary Outcome Measure Information:

Title

score of self-rating depression scale

Description

Reduction in the severity of depression, measured at the end of the intervention primarily as a continuous variable on self-rating depression scale (SDS)

Time Frame

baseline, after intervention(4 week), after follow-up(4 week)

Title

score of Hamilton Anxiety Rating Scale

Description

Reduction in the severity of depression, measured at the end of the intervention primarily as a continuous variable on Hamilton Anxiety Rating Scale (HAMA)

Time Frame