Clinical trial NCT05106868: Acupuncture for Patients With Major Depressive Disorder
Official title: Acupuncture for Patients With Major Depressive Disorder: Study Protocol of a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Major Depressive Disorder
Keywords: acupuncture
major depressive disorder
randomized controlled trial
Lead sponsor: Chengdu University of Traditional Chinese Medicine
Sponsor class: OTHER
First posted: 2021-11-04
Enrollment: 123
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: score of Hamilton Depression Rating Scale-24
timeFrame: change from baseline to 4 weeks after intervention, after follow-up(4 week)
Secondary outcomes:
measure: score of self-rating depression scale
timeFrame: baseline, after intervention(4 week), after follow-up(4 week)
measure: score of Hamilton Anxiety Rating Scale
timeFrame: baseline, after intervention(4 week) , after follow-up(4 week)
measure: score of Social Disability Screening Schedule
timeFrame: baseline, after intervention(4 week) , after follow-up(4 week)
measure: score of Pittsburgh sleep quality index (PSQI)
timeFrame: baseline, after intervention(4 week) , after follow-up(4 week)
measure: motor threshold (MT)
timeFrame: baseline, after intervention(4 week) , after follow-up(4 week)
measure: Intra-cortical facilitation (ICF)
timeFrame: baseline, after intervention(4 week) , after follow-up(4 week)
measure: cortical resting period (CSP)
timeFrame: baseline, after intervention(4 week) , after follow-up(4 week)
measure: intra-cortical inhibition (ICI)
timeFrame: baseline, after intervention(4 week) , after follow-up(4 week)
measure: IAPS Evoked Event-related Potentials (ERP)
timeFrame: baseline, after intervention(4 week), after follow-up(4 week)
measure: Evoked Event-related Potentials (ERP) in TMS-EEG
timeFrame: baseline, after intervention(4 week), after follow-up(4 week)
measure: Adverse events
timeFrame: during intervention(4 week)
Other outcomes:
Locations:
Study officials:
affiliation: Institute of Science and Technology Development, Sichuan University
name: Jian Huang
role: STUDY_CHAIR
References: