Acupuncture for Patients With Major Depressive Disorder

NCT ID: NCT05106868

Last Updated: 2021-11-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

123 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-11-01

Study Completion Date

2023-06-30

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.

Detailed Description

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Conditions

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Major Depressive Disorder

Keywords

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acupuncture major depressive disorder randomized controlled trial

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

acupuncture

Intervention Type DEVICE

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 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.

Group Type SHAM_COMPARATOR

acupuncture

Intervention Type DEVICE

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.

waiting-list

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Chengdu University of Traditional Chinese Medicine

OTHER

Sponsor Role lead

Responsible Party

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Di Qin

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jian Huang

Role: STUDY_CHAIR

Institute of Science and Technology Development, Sichuan University

Central Contacts

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Zhong Zheng, PhD

Role: CONTACT

Phone: 18980601861

Email: [email protected]

Rongjiang Jin

Role: CONTACT

Email: [email protected]

Other Identifiers

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2019-1273

Identifier Type: -

Identifier Source: org_study_id