Major Depressive Disorder
Conditions
Keywords
acupuncture, biological specificity, major depressive disorder
Brief summary
Acupoints are the stimulus points and reactive points for acupuncture to treat the diseases. Therefore, this study is designed to detect the biological specificity of acupoints in healthy participants and major depressive disorder (MDD) participants by using multiple objective assessment tools. And then acupoints that are statistically different between the two groups will be defined as strong reaction points, and other acupoints without statistically different will be defined as weak response points. In addition, this clinical trial will be conducted to explore whether the efficacy of stimulating strong reaction acupoints is more effective than weak reaction points, thereby confirming the specificity of the acupoint.
Detailed description
Part 1: This study will include 40 patients with MDD and 40 healthy control participants. Infrared thermography (IRT), laser doppler flowmetry (LDF), functional near-infrared spectroscopy (FNIS), and digital pressure pain gauge (PPG), respectively, will be adopted to assess 4 kinds of biological specificity of MDD related acupoints, namely, the thermal transport specificity, the microcirculatory specificity, the metabolic specificity, and the pain sensitivity specificity. Based on the results of this study, we will select acupoints with statistical differences between the two groups as the strong reaction acupoints and the remaining acupoints as the weak reaction acupoints. Part 2: A total of 120 participants with MDD who meet the inclusion criteria will be included in the study. All participants will receive basic treatment of selective serotonin reuptake inhibitors (SSRIs) antidepressants. They will be randomly divided into the acupuncture (strong reaction acupoints) group, acupuncture (weak reaction acupoints) group, and sham acupuncture group. We will evaluate the therapeutic effect and safety of acupuncture for MDD, furthermore, to demonstrate whether stimulating strong reaction acupoints has more advantages in the treatment of MDD than weak reaction acupoints.
Interventions
DRUGSSRIs
In this study, SSRIs antidepressants will be used, and the oral dose will be determined by the clinical specialist. Once-daily for 6 weeks.
PROCEDUREacupuncture (strong reaction acupoints)
This study will use the intradermal needle as an acupuncture intervention. Strong reaction acupoints selected in the first part of the study will be stimulated. According to the position of the acupoints, choose a needle of φ0.20\*1.5m or φ0.20\*1.2mm. Press the needle to insert the acupoint vertically and retain it in the skin. After the intervention, the needle will be retained for 72 hours with a day of rest after removal. During needle retention, participants will be instructed to press the acupoints 3-4 times a day for about 1 minute each time, with the amount of stimulation as much as the patient can tolerate, at an interval of about 4 hours. A total of 10 treatment sessions will be performed for 6 weeks.
PROCEDUREacupuncture (weak reaction acupoints)
This study will use the intradermal needle as an acupuncture intervention. Weak reaction acupoints selected in the first part of the study will be stimulated. According to the position of the acupoints, choose a needle of φ0.20\*1.5m or φ0.20\*1.2mm. Press the needle to insert the acupoint vertically and retain it in the skin. After the intervention, the needle will be retained for 72 hours with a day of rest after removal. During needle retention, participants will be instructed to press the acupoints 3-4 times a day for about 1 minute each time, with the amount of stimulation as much as the patient can tolerate, at an interval of about 4 hours. A total of 10 treatment sessions will be performed for 6 weeks.
PROCEDUREsham acupuncture
Sham acupuncture will use the same size, color, and material as the verum intradermal needle with a thin silicone pad in the middle instead of the needle body. The sham acupuncture will be needled on the points 1cm lateral to strong reaction acupoints. After the intervention, the needle will be retained for 72 hours with a day of rest after removal. A total of 10 sessions will be performed for 6 weeks.
Sponsors
The Zhejiang Provincial Tongde Hospital
The Affiliated Hangzhou First People's Hospital
The Third Affiliated hospital of Zhejiang Chinese Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
12 Years to 60 Years
Healthy volunteers
Yes
Inclusion criteria
1. Inclusion criteria for health volunteers: * Healthy volunteers who could provide a recent depression screening report, and confirm they have not any cardiovascular, respiratory, digestive, urinary, hematological, endocrine, or neurological disease; * 12 ≤ age ≤60 years, male or female; * Participants have clear consciousness and could communicate with others normally; * Participants could understand the full study protocol and have high adherence. Written informed consent is signed by themselves or their lineal kin (for minor participants, their guardian should sign the informed consent form for them). 2. Inclusion criteria for MDD: * Patients should meet the diagnostic criteria of the International Classification of Diseases 10th Edition (ICD-10) diagnostic criteria for depression and are evaluated as moderate or severe MDD according to the severity of depression; * 12 ≤ age ≤60, male or female; * Participants have clear consciousness and could communicate with others normally; * Participants could understand the full study protocol and have high adherence. Written informed consent is signed by themselves or their lineal kin (for minor participants, their guardian should sign the informed consent form for them).
Exclusion criteria
1.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in the Patient Health Questionaire-9 Items (PHQ -9) | Baseline, 3 weeks after treatment, 6 weeks after treatment, at 4-week follow-up. | The PHQ-9 scale has a total of 9 questions, each with a score of 0-3 (none: 0; a few days: 1; more than half of the time: 2; almost every day: 3), with a total score of 0-27. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Temperature change | Baseline, 6 weeks after treatment. | NEC R450 Infrared thermography will be used to record baseline temperature and the temperature change of relevant sites. The average temperature value of relevant sites in the six infrared thermograms is its base temperature. |
| Microcirculatory change | Baseline, 6 weeks after treatment. | The PeriFlux System 5000 is a four-channel laser Doppler flowmeter that detects the rate of blood cell movement and its distribution of relevant test sites. The accompanying Perisoft for Windows flow analysis software generates the blood flow curve and analyzes the microcirculatory perfusion unit (PU) at the relevant test site and the 10 min average is used as the base PU. |
| Change in the Self-Rating Depression Scale (SDS) | Baseline, 3 weeks after treatment, 6 weeks after treatment, at 4-week follow-up. | This scale has 20 questions. Participants should choose the answer that best matches their situation based on their feelings in the last week or less. Depression severity = total score/80 (0-0.5 means no depression, 0.5-0.59 means mild depression, 0.6-0.69 means moderate depression, and 0.7 or more means severe depression). |
| Pain sensitivity change | Baseline, 6 weeks after treatment. | A Digital pressure pain gauge will be used to measure the local pain threshold (PT). The probe of the pain gauge will be placed vertically on the relevant test site, and the pressure will be applied slowly and steadily, and when the participant feels pain, the pressure will stop and the reading on the gauge is the PT. The average value of the PT of the same relevant test sites will be calculated as their base PT. |
| Adverse Events | Up to 10 weeks | Any adverse events that occur during the trial will be recorded and analyzed for the cause. |
| Metabolic change | Baseline, 6 weeks after treatment. | The INVOS 5100C quad-channel NIR spectrometer detects regional oxygen saturation (rSO2). rSO2 is analyzed by the INVOS Analytics Tool software and the 10 min average is used as the base rSO2. |
Countries
China
Contacts
Primary ContactXiaomei Shao, Ph.D
Backup ContactMingqi Tu
Outcome results
None listed