Acupuncture for Patients With Major Depressive Disorder

NCT05106868 | Unknown DMC

• 1 other identifier: 2019-1273
• Study Type: interventional
• Target: 123
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Major Depressive Disorder

Keywords

acupuncture; major depressive disorder; randomized controlled trial

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (11)

• score of self-rating depression scale

  baseline, after intervention(4 week), after follow-up(4 week)

• score of Hamilton Anxiety Rating Scale

  baseline, after intervention(4 week) , after follow-up(4 week)

• score of Social Disability Screening Schedule

  baseline, after intervention(4 week) , after follow-up(4 week)

• score of Pittsburgh sleep quality index (PSQI)

  baseline, after intervention(4 week) , after follow-up(4 week)

• motor threshold (MT)

  baseline, after intervention(4 week) , after follow-up(4 week)

Study Arms (3)

acupuncture

EXPERIMENTAL

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

sham acupuncture

SHAM COMPARATOR

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

waiting-list

NO INTERVENTION

Interventions

acupuncture 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.

acupuncture; sham acupuncture

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Chengdu University of Traditional Chinese Medicine: lead

MeSH Terms

Conditions

Depressive Disorder, Major

Interventions

Acupuncture Therapy

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics

Study Officials

• Jian Huang

  Institute of Science and Technology Development, Sichuan University

  STUDY CHAIR

Central Study Contacts

Zhong Zheng, PhD

CONTACT

18980601861; zhengzhong1963@163.com

Rongjiang Jin

CONTACT

cdzyydxjrj@126.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: October 25, 2021
• First Posted: November 4, 2021
• Study Start: November 1, 2021
• Primary Completion: December 30, 2022
• Study Completion: June 30, 2023
• Last Updated: November 4, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share