Acupuncture for Patients With Major Depressive Disorder

Study Overview
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Brief Summary
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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.

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

Conditions
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Major Depressive Disorder

Intervention / Treatment
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* Device: acupuncture


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: acupuncture<br>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. | Device: acupuncture<br>* 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.<br>|
| Sham Comparator: sham acupuncture<br>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. | Device: acupuncture<br>* 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.<br>|
| No Intervention: waiting-list<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | change from baseline to 4 weeks after intervention, after follow-up(4 week) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | baseline, after intervention(4 week), after follow-up(4 week) | 
| 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) | baseline, after intervention(4 week) , after follow-up(4 week) | 
| score of Social Disability Screening Schedule | change of score of Social Disability Screening Schedule (SDSS) | baseline, after intervention(4 week) , after follow-up(4 week) | 
| score of Pittsburgh sleep quality index (PSQI) | change of score of Pittsburgh sleep quality index (PSQI) | baseline, after intervention(4 week) , after follow-up(4 week) | 
| motor threshold (MT) | motor threshold (MT) measured by Brain Ultimate Combined with MEB-2312 EMG/evoked potentiometer | baseline, after intervention(4 week) , after follow-up(4 week) | 
| Intra-cortical facilitation (ICF) | Intra-cortical facilitation (ICF) measured by Brain Ultimate Combined with MEB-2312 EMG/evoked potentiometer | baseline, after intervention(4 week) , after follow-up(4 week) | 
| 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)] | 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 | baseline, after intervention(4 week) , after follow-up(4 week) | 
| IAPS Evoked Event-related Potentials (ERP) | IAPS Evoked Event-related Potentials (ERP) | baseline, after intervention(4 week), after follow-up(4 week) | 
| Evoked Event-related Potentials (ERP) in TMS-EEG | Evoked Event-related Potentials (ERP) in TMS-EEG | baseline, after intervention(4 week), after follow-up(4 week) | 
| Adverse events | Adverse events | during intervention(4 week) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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acupuncture, major depressive disorder, randomized controlled trial