Back to resultsEfficacy and Safety of Intradermal Acupuncture for Major Depressive Disorder
Primary Purpose
Major Depressive Disorder
Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
SSRIs
SIA
AIA
Sponsored by
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
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); No depression-related treatment in the past two weeks, except 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 difficult to cooperate with doctors. Participating in other clinical trials.
Sites / Locations
- the Third affiliated hospital of Zhejiang Chinese Medical universityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Sham Comparator
Experimental
Arm Label
Waiting list group
SIA+SSRIs group
AIA+SSRIs group
Arm Description
This group will include 30 patients with MDD who will be treated with oral SSRIs only, the dosage of which will be determined by the psychiatrist. After 6 weeks, patients could choose 6 weeks' intradermal acupuncture treatments free of charge.
This group will include 30 patients with MDD who will be treated with sham intradermal acupuncture 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 30 patients with MDD who will be treated with active intradermal acupuncture 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.
Changes in the Treatment Emergent Symptom Scale (TESS) Scores
The TESS is often used to assess the side effects of drugs. It contains 35 symptom items and 2 total assessment items, including behavioural toxicity, laboratory tests, autonomic nervous system, nervous and cardiovascular system, etc. Each of these symptoms is graded into 5 levels of severity (0-4), with the higher the score the more severe the side effects.
Adverse Events
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.
Full Information
NCT ID
NCT05605002
First Posted
August 31, 2022
Last Updated
November 2, 2022
Sponsor
Xiaomei Shao
Collaborators
Zhejiang Provincial Tongde Hospital, First People's Hospital of Hangzhou, The First Affiliated Hospital of Zhejiang Chinese Medical University
1. Study Identification
Unique Protocol Identification Number
NCT05605002
Brief Title
Efficacy and Safety of Intradermal Acupuncture for Major Depressive Disorder
Official Title
Efficacy and Safety of Intradermal Acupuncture for Major Depressive Disorder: a Study Protocol for a Multicenter, Prospective, Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
November 2022
Overall Recruitment Status
Recruiting
Study Start Date
January 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 a common mental illness that severely affects the health and quality of life of patients. Treatment with acupuncture alone or a combination of appropriate adjuncts has been reported to be significantly effective in reducing the severity of MDD, relieving patients' somatic symptoms and improving sleep. This study will focus on the intradermal acupuncture, which is more convenient, gentler and has longer lasting effects. The aim is to study the efficacy and safety of intradermal acupuncture for MDD, and to preliminarily explore the central nervous mechanisms by which it exerts its therapeutic effects.
Detailed Description
A total of 90 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 and examine whether intradermal acupuncture reduces side effects and improves the efficacy of SSRIs for MDD. In addition, the study will use magnetic resonance imaging (MRI) to study the possible central mechanisms by which intradermal acupuncture 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
90 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Waiting list group
Arm Type
Active Comparator
Arm Description
This group will include 30 patients with MDD who will be treated with oral SSRIs only, the dosage of which will be determined by the psychiatrist. After 6 weeks, patients could choose 6 weeks' intradermal acupuncture treatments free of charge.
Arm Title
SIA+SSRIs group
Arm Type
Sham Comparator
Arm Description
This group will include 30 patients with MDD who will be treated with sham intradermal acupuncture 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+SSRIs group
Arm Type
Experimental
Arm Description
This group will include 30 patients with MDD who will be treated with active intradermal acupuncture 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)
SSRIs
Other Intervention Name(s)
selective 5-hydroxytryptamine reuptake inhibitors
Intervention Description
SSRIs antidepressants, including fluoxetine, paroxetine, sertraline, citalopram, etc., will be administered at oral doses determined by the psychiatrist. Once daily for 6 weeks.
Intervention Type
Procedure
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
Procedure
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
Title
Changes in the Treatment Emergent Symptom Scale (TESS) Scores
Description
The TESS is often used to assess the side effects of drugs. It contains 35 symptom items and 2 total assessment items, including behavioural toxicity, laboratory tests, autonomic nervous system, nervous and cardiovascular system, etc. Each of these symptoms is graded into 5 levels of severity (0-4), with the higher the score the more severe the side effects.
Time Frame
Baseline, 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
Other Pre-specified Outcome Measures:
Title
Magnetic resonance imaging (MRI) data acquisition
Description
Brain MRI will be taken by the 3.0 T magnetic resonance scanner to analyse the functional connectivity of the patient's brain regions, particularly the hypothalamus, 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 the 3.0 T magnetic resonance scanner to detect the neurometabolic change in patients' brain regions, particularly the hypothalamus, before and after the intervention.
Time Frame
Baseline, 6 weeks after treatment
Title
Blood samples biobank establishment
Description
Blood samples will be collected to test the function of the hypothalamic-pituitary-adrenal axis, including the level of adrenocorticotropic hormone (ACTH) and cortisol (Cor).
Time Frame
Baseline, 6 weeks after treatment
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);
No depression-related treatment in the past two weeks, except 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 difficult to cooperate 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
City
Hangzhou
State/Province
Zhejiang
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xiaomei Shao
Phone
+8618957130287
Email
shaoxiaomei@zcmu.edu.cn
First Name & Middle Initial & Last Name & Degree
Xiaoting Wu
Phone
+8618196671636
Email
xiaotwu@163.com
12. IPD Sharing Statement
Learn more about this trial
Efficacy and Safety of Intradermal Acupuncture for Major Depressive Disorder
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