Acupuncture for Patients With Major Depressive Disorder

Chengdu University of Traditional Chinese Medicine

Status: Unknown

Conditions: Major Depressive Disorder

Treatments: Device: acupuncture

Study type: Interventional

Funder types: Other

Identifiers

NCT05106868

2019-1273

Details and patient eligibility

About

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.

Enrollment: 123 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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123 participants in 3 patient groups

acupuncture

Experimental group

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.

Treatment:

Device: acupuncture

sham acupuncture

Sham Comparator group

Description:

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.

Treatment:

Device: acupuncture

waiting-list

No Intervention group