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The Efficacy and Cerebral Mechanism of Intradermal Acupuncture for Major Depressive Disorder

Primary Purpose

Major Depressive Disorder

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
SSRI
SIA
AIA
Sponsored by
Xiaomei Shao
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Major Depressive Disorder focused on measuring Major Depressive Disorder, Intradermal Acupuncture, Magnetic Resonance Imaging

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Patients diagnosed with MDD according to the International Classification of Disease-10 (ICD-10); Aged between 18 and 60 years (no limitation on gender); Administration of SSRIs; Patients undergoing MRI and MRS should be right-handed and free of traumatic brain injury, claustrophobia or metal implants; Written informed consent is obtained by the person or guardian. Exclusion Criteria: ICD-10 diagnoses: schizophrenia, bipolar disorder, manic episode or other psychotic disorders; alcohol and drug addiction; Significant skin lesions, severe allergic diseases, tumors, and severe or unstable internal diseases involving the cardiovascular, digestive, endocrine, or hematological system; Acute suicidal tendency; Allergy to adhesive tape and fear of intradermal acupuncture; Pregnancy and lactation; Mental retardation and difficulty cooperating with doctors. Participating in other clinical trials.

Sites / Locations

  • the Third affiliated hospital of Zhejiang Chinese Medical university [Recruiting]Recruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Other

Sham Comparator

Experimental

Arm Label

Waiting list group

SIA group

AIA group

Arm Description

This group will include 40 patients with MDD who will be treated with oral SSRIs only, the dosage of which will be determined by the psychiatrist. At the end of this trial, patients could choose 6 weeks' intradermal acupuncture treatments free of charge.

This group will include 40 patients with MDD who will be treated with sham intradermal acupuncture (SIA) combined with SSRIs. Acupoints related to MDD will be stimulated by acupuncturists and the dosage of oral SSRIs will be determined by the psychiatrist.

This group will include 40 patients with MDD who will be treated with active intradermal acupuncture (AIA) combined with SSRIs. Acupoints related to MDD will be stimulated by acupuncturists and the dosage of oral SSRIs will be determined by the psychiatrist.

Outcomes

Primary Outcome Measures

Changes in the Hamilton Depression Scale-17 (HAMD-17) Scores
The HAMD scale is the most commonly used in the clinical assessment of depression, including 17 items. The higher the score, the more severe the depression. 0-7 means no depressive symptoms, 8-17 means mild depression, 18-24 was divided into moderate depression, and 25-52 was divided into severe depression.

Secondary Outcome Measures

Changes in the Self-Rating Depression Scale (SDS) Scores
The standard score is the total of all scores multiplied by 1.25 to the nearest whole number on this scale, which has 20 questions. A standard score below 50 is normal; 50-60 is mild depression; 61-70 is moderate depression; 70 or more is severe depression.
Changes in the Pittsburgh Sleep Quality Index (PSQI) Scores
The PSQI is used to assess the sleep quality of the participant in the last 1 month and consisted of 19 self-rated and 5 other rated items. The higher the score, the worse the sleep quality. Sleep quality is divided into 4 levels according to the total score.

Full Information

First Posted
January 31, 2023
Last Updated
January 31, 2023
Sponsor
Xiaomei Shao
Collaborators
Zhejiang Provincial Tongde Hospital, First People's Hospital of Hangzhou, The First Affiliated Hospital of Zhejiang Chinese Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT05720637
Brief Title
The Efficacy and Cerebral Mechanism of Intradermal Acupuncture for Major Depressive Disorder
Official Title
The Efficacy and Cerebral Mechanism of Intradermal Acupuncture for Major Depressive Disorder: a Study Protocol for a Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 1, 2022 (Actual)
Primary Completion Date
December 30, 2025 (Anticipated)
Study Completion Date
December 30, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Xiaomei Shao
Collaborators
Zhejiang Provincial Tongde Hospital, First People's Hospital of Hangzhou, The First Affiliated Hospital of Zhejiang Chinese Medical University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
Major depressive disorder (MDD) is highly prevalent, affecting nearly 4% of the global population. Pharmacotherapy is the frontline treatment recommended by the guideline, but it also has some limitations such as delayed onset, inadequate response, and drug resistance. Intradermal acupuncture (IA) is a method of using short indwelling needles retained under the skin to produce continuous stimulation for long-term efficacy. It has been reported that IA combination medication appears to be more valuable than medication alone in the treatment of MDD, however, there is a lack of high-quality clinical evidence.While several studies have proposed that manual or electroacupuncture can improve MDD symptoms by modulating brain networks, the cerebral mechanism of IA as superficial acupuncture for MDD has not been reported. Hence, we designed a multicentre randomized controlled trial to assess the clinical efficacy and safety of IA for MDD and preliminarily explore the potential therapeutic mechanisms for IA by functional magnetic resonance imaging (fMRI) and magnetic resonance spectroscopy (MRS).
Detailed Description
A total of 120 patients with MDD who meet the inclusion criteria will be included in the study. Participants will be randomly assigned 1:1:1 to the waiting list group (patients in this group will be treated with selective 5-hydroxytryptamine reuptake inhibitors (SSRIs) only), sham intradermal acupuncture combined with SSRIs (SIA) group and active intradermal acupuncture combined with SSRIs (AIA) group. The study will assess the efficacy and safety of intradermal acupuncture for MDD. In addition, we will explore the possible cerebral mechanisms by which IA exerts its antidepressant effects.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Major Depressive Disorder
Keywords
Major Depressive Disorder, Intradermal Acupuncture, Magnetic Resonance Imaging

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Waiting list group
Arm Type
Other
Arm Description
This group will include 40 patients with MDD who will be treated with oral SSRIs only, the dosage of which will be determined by the psychiatrist. At the end of this trial, patients could choose 6 weeks' intradermal acupuncture treatments free of charge.
Arm Title
SIA group
Arm Type
Sham Comparator
Arm Description
This group will include 40 patients with MDD who will be treated with sham intradermal acupuncture (SIA) combined with SSRIs. Acupoints related to MDD will be stimulated by acupuncturists and the dosage of oral SSRIs will be determined by the psychiatrist.
Arm Title
AIA group
Arm Type
Experimental
Arm Description
This group will include 40 patients with MDD who will be treated with active intradermal acupuncture (AIA) combined with SSRIs. Acupoints related to MDD will be stimulated by acupuncturists and the dosage of oral SSRIs will be determined by the psychiatrist.
Intervention Type
Drug
Intervention Name(s)
SSRI
Other Intervention Name(s)
selective 5-hydroxytryptamine reuptake inhibitor
Intervention Description
SSRIs antidepressants, including fluoxetine, paroxetine, sertraline, citalopram, etc., will be administered at oral doses determined by the psychiatrist. Once daily for the duration of the trial.
Intervention Type
Device
Intervention Name(s)
SIA
Other Intervention Name(s)
sham intradermal acupuncture
Intervention Description
This study will select 4 acupoints (all taken bilaterally) commonly used to treat MDD, namely Taichong (LR3), Neiguan (PC6), Sanyinjiao (SP6) and Shenmen (HT7). The SIA will use the same size, colour and material as the AIA with a thin silicone pad in the middle instead of the needle body. SIA will be attached to the acupoints and retained for 72 hours, removed and rested for one day. A total of 10 sessions will be performed over a period of 6 weeks.
Intervention Type
Device
Intervention Name(s)
AIA
Other Intervention Name(s)
active intradermal acupuncture
Intervention Description
This study will select 4 acupoints (all taken bilaterally) commonly used to treat MDD, namely Taichong (LR3), Neiguan (PC6), Sanyinjiao (SP6) and Shenmen (HT7). Depending on acupoints' location, a φ0.20*1.5mm or φ0.20*1.2mm AIA will be selected. Press the AIA to insert it vertically into the acupoint and retain it in the skin. AIA will be retained for 72 hours with a day's rest after removal. During the period of needle retention, participants will be instructed to press the AIA 3-4 times a day for approximately 1 minute each time, with as much stimulation as the patient can tolerate, at intervals of approximately 4 hours. A total of 10 sessions will be performed over a period of 6 weeks.
Primary Outcome Measure Information:
Title
Changes in the Hamilton Depression Scale-17 (HAMD-17) Scores
Description
The HAMD scale is the most commonly used in the clinical assessment of depression, including 17 items. The higher the score, the more severe the depression. 0-7 means no depressive symptoms, 8-17 means mild depression, 18-24 was divided into moderate depression, and 25-52 was divided into severe depression.
Time Frame
Baseline, 3 weeks after treatment, 6 weeks after treatment, at 4-week follow-up.
Secondary Outcome Measure Information:
Title
Changes in the Self-Rating Depression Scale (SDS) Scores
Description
The standard score is the total of all scores multiplied by 1.25 to the nearest whole number on this scale, which has 20 questions. A standard score below 50 is normal; 50-60 is mild depression; 61-70 is moderate depression; 70 or more is severe depression.
Time Frame
Baseline, 3 weeks after treatment, 6 weeks after treatment, at 4-week follow-up.
Title
Changes in the Pittsburgh Sleep Quality Index (PSQI) Scores
Description
The PSQI is used to assess the sleep quality of the participant in the last 1 month and consisted of 19 self-rated and 5 other rated items. The higher the score, the worse the sleep quality. Sleep quality is divided into 4 levels according to the total score.
Time Frame
Baseline, 3 weeks after treatment, 6 weeks after treatment, at 4-week follow-up
Other Pre-specified Outcome Measures:
Title
Magnetic resonance imaging (MRI) data acquisition
Description
Brain MRI will be taken by a 3.0T MRI scanner to analyze the activity function of depressed patients' brain regions, such as the amygdala and hippocampus, before and after the intervention.
Time Frame
Baseline, 6 weeks after treatment
Title
Magnetic resonance spectroscopy (MRS ) data acquisition
Description
MRS will be taken by a 3.0T MRI scanner to detect neurometabolic changes in depressed patients' brain regions, particularly the amygdala, before and after the intervention.
Time Frame
Baseline, 6 weeks after treatment
Title
Blood samples biobank establishment
Description
blood samples will be collected to establish a blood sample bank and serum 5-HT levels will be tested.
Time Frame
Baseline, 6 weeks after treatment
Title
Evaluation of acupuncture compliance
Description
At the end of the acupuncture intervention (end of week 6), compliance will be evaluated with the formula: Compliance Rate = (actual treatment times/total treatment times) *100%.
Time Frame
6 weeks after treatment
Title
Adverse Events
Description
Adverse events such as bleeding, haematoma, or unbearable pain caused by the needle, as well as drug-induced nausea, vomiting or dizziness, will all be recorded.
Time Frame
Up to 10 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients diagnosed with MDD according to the International Classification of Disease-10 (ICD-10); Aged between 18 and 60 years (no limitation on gender); Administration of SSRIs; Patients undergoing MRI and MRS should be right-handed and free of traumatic brain injury, claustrophobia or metal implants; Written informed consent is obtained by the person or guardian. Exclusion Criteria: ICD-10 diagnoses: schizophrenia, bipolar disorder, manic episode or other psychotic disorders; alcohol and drug addiction; Significant skin lesions, severe allergic diseases, tumors, and severe or unstable internal diseases involving the cardiovascular, digestive, endocrine, or hematological system; Acute suicidal tendency; Allergy to adhesive tape and fear of intradermal acupuncture; Pregnancy and lactation; Mental retardation and difficulty cooperating with doctors. Participating in other clinical trials.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Xiaomei Shao, Ph.D
Phone
+8618957130287
Email
shaoxiaomei@zcmu.edu.cn
First Name & Middle Initial & Last Name or Official Title & Degree
Xiaoting Wu
Phone
+8618196671636
Email
xiaotwu@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xiaomei Shao, Ph.D
Organizational Affiliation
The Third Affiliated hospital of Zhejiang Chinese Medical University
Official's Role
Principal Investigator
Facility Information:
Facility Name
the Third affiliated hospital of Zhejiang Chinese Medical university [Recruiting]
City
Hangzhou
State/Province
Zhejiang
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xiaomei Shao, Ph.D
Phone
+8618957130287
Email
shaoxiaomei@zcmu.edu.cn

12. IPD Sharing Statement

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The Efficacy and Cerebral Mechanism of Intradermal Acupuncture for Major Depressive Disorder

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