Acupuncture for Patients With Major Depressive Disorder
Study Details
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: 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. |
Device: acupuncture
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.
|
| Sham Comparator: sham 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. |
Device: acupuncture
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.
|
| No Intervention: waiting-list
|
Outcome Measures
Primary Outcome Measures
- 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
- 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 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)
- 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)
- 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
- 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)]
- 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
- 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
- Adverse events [during intervention(4 week)]
Adverse events
Eligibility Criteria
Criteria
Inclusion Criteria:
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Right-handed participants aged between 18 to 60 years;
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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);
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participants with score of HAMD-24 between 8 to 35;
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participants without anti-depressive medication more than 3 months;
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participants willing to comply with the study protocol;
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participants willing to sign informed consent form.
Exclusion Criteria:
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participants with severe medical visceral condition and chronic diseases, such as hypertension, coronary heart disease, hyperthyroidism, hypothyroidism or diabetes and other endocrine system diseases;
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participants with brain organic diseases: such as birth injury, trauma, encephalitis, tumor, etc.;
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participants with Peripheral nerve and muscular system diseases;
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participants with severe anxiety, obsessive-compulsive disorder, or a history of mania or hypomania;
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Recently taken drugs that may cause mood disorders;
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Severe bleeding tendency, allergic constitution and skin disease patients;
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pregnant or lactation women;
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Persons with visual and hearing disabilities;
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Participants with pacemakers, deep brain stimulators, vagus nerve stimulators, metal internal fixators, etc
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participate in other clinical trials at the same time
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Chengdu University of Traditional Chinese Medicine
Investigators
- Study Chair: Jian Huang, Institute of Science and Technology Development, Sichuan University
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 2019-1273