Acupuncture for Patients With Major Depressive Disorder

Not Applicable

• Conditions: Major Depressive Disorder
• Interventions: Device: acupuncture

• Registration Number: NCT05106868
• Lead Sponsor: Chengdu University of Traditional Chinese Medicine

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2021-10
• Study First Submitted: 2021-10-25
• Study First Submitted QC: 2021-10-25
• Last Update Submitted: 2021-10-25
• Study Start: 2021-11-01
• Study First Posted: 2021-11-04
• Last Update Posted: 2021-11-04
• Primary Completion: 2022-12-30
• Study Completion: 2023-06-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 123

Inclusion Criteria

1. Right-handed participants aged between 18 to 60 years;
2. 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);
3. participants with score of HAMD-24 between 8 to 35;
4. participants without anti-depressive medication more than 3 months;
5. participants willing to comply with the study protocol;
6. participants willing to sign informed consent form.

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
acupuncture	acupuncture	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.
sham acupuncture	acupuncture	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.

Primary Outcome Measures

Name	Time	Method
score of Hamilton Depression Rating Scale-24	change from baseline to 4 weeks after intervention, after follow-up(4 week)	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

Name	Time	Method
score of self-rating depression scale	baseline, after intervention(4 week), after follow-up(4 week)	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 Pittsburgh sleep quality index (PSQI)	baseline, after intervention(4 week) , after follow-up(4 week)	change of score of Pittsburgh sleep quality index (PSQI)
cortical resting period (CSP)	baseline, after intervention(4 week) , after follow-up(4 week)	cortical resting period (CSP) measured by Brain Ultimate Combined with MEB-2312 EMG/evoked potentiometer \[Time Frame: baseline, after intervention(4 week), after follow-up(4 week)\]
IAPS Evoked Event-related Potentials (ERP)	baseline, after intervention(4 week), after follow-up(4 week)	IAPS Evoked Event-related Potentials (ERP)
Evoked Event-related Potentials (ERP) in TMS-EEG	baseline, after intervention(4 week), after follow-up(4 week)	Evoked Event-related Potentials (ERP) in TMS-EEG
motor threshold (MT)	baseline, after intervention(4 week) , after follow-up(4 week)	motor threshold (MT) measured by Brain Ultimate Combined with MEB-2312 EMG/evoked potentiometer
Intra-cortical facilitation (ICF)	baseline, after intervention(4 week) , after follow-up(4 week)	Intra-cortical facilitation (ICF) measured by Brain Ultimate Combined with MEB-2312 EMG/evoked potentiometer
score of Hamilton Anxiety Rating Scale	baseline, after intervention(4 week) , after follow-up(4 week)	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	baseline, after intervention(4 week) , after follow-up(4 week)	change of score of Social Disability Screening Schedule (SDSS)
intra-cortical inhibition (ICI)	baseline, after intervention(4 week) , after follow-up(4 week)	intra-cortical inhibition (ICI) measured by Brain Ultimate Combined with MEB-2312 EMG/evoked potentiometer
Adverse events	during intervention(4 week)	Adverse events