Acupuncture for Patients With Major Depressive Disorder

Major Depressive Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05106868
• Other study ID #: 2019-1273
• Status: Not yet recruiting
• Phase: N/A
• Start date: November 1, 2021
• Est. completion date: June 30, 2023

Study information

• Verified date: October 2021
• Source: Chengdu University of Traditional Chinese Medicine
• Contact: Zhong Zheng, PhD
• Phone: 18980601861
• Email: zhengzhong1963[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 123
• Est. completion date: June 30, 2023
• Est. primary completion date: December 30, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Disease
• Major Depressive Disorder

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Chengdu University of Traditional Chinese Medicine

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	IAPS Evoked Event-related Potentials (ERP)	IAPS Evoked Event-related Potentials (ERP)	baseline, after intervention(4 week), after follow-up(4 week)
Secondary	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)
Secondary	Adverse events	Adverse events	during intervention(4 week)