Back to resultsIntradermal Acupuncture Versus Sham Acupuncture and SSRI for Treating Adolescents With Major Depressive Disorder
Primary Purpose
Major Depressive Disorder
Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
SSRI
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, Randomized Controlled Trial, Adolescent
Eligibility Criteria
Inclusion Criteria: Patients diagnosed with MDD according to the International Classification of Disease-10 (ICD-10); HAMD-17≥7 Aged between 12 and 17 years (no limitation on gender); Take SSRI for at least two weeks; 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
Other
Sham Comparator
Experimental
Arm Label
Waiting list group
SIA+SSRIs group
AIA+SSRIs 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. After 6 weeks, 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 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 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 Patient Health Questionaire-9 (PHQ-9)
The PHQ-9 was used to screen survey respondents for depression. The scale was developed according to the criteria for diagnosing depression in the American Diagnostic and Statistical Manual of Mental Disorders (4th edition) and is a concise, validated self-assessment and screening tool for depression. There are 9 questions, each with a score of 0-3 (none: 0; a few days: 1; more than half the time: 2; almost every day: 3), for a total score of 0-27.
Changes in the Short Form 36 Questionnaire（SF-36）
The SF-36 scale has been developed by the American Medical Research Group as a universal scale for measuring quality of life and is widely recognized and used internationally. This scale has 8 dimensions to evaluate health-related quality of life, which are divided into two major categories: physical function (PF), physical function (RP), somatic pain (BP), general health (GH), energy (VT), social function (SF), emotional function (RE), and mental health (MH). the SF-36 scale is to a certain extent a better response to patients' quality of life.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05832619
Brief Title
Intradermal Acupuncture Versus Sham Acupuncture and SSRI for Treating Adolescents With Major Depressive Disorder
Official Title
Intradermal Acupuncture Versus Sham Acupuncture and SSRI for Treating Adolescents With Major Depressive Disorder: a Study Protocol for a Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
April 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
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 prevalent mental illness characterised by influencing the health and quality of life of patients，often manifesting in individuals under the age of 18. It has been wildly confirmed that acupuncture alone or in combination with the applicable adjuvant therapy for MDD can not only relieve patients' physical symptoms, but also enhance sleep quality. Intradermal acupuncture, as an acceptable and long-lasting treatment modality, is the focus of this research. This study was conducted to investigate the efficacy of intradermal acupuncture in the treatment of MDD.
Detailed Description
This study will enroll a total of 120 adolescents with MDD who meet the inclusion criteria. 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 is aim to evaluate the efficacy of intradermal acupuncture for MDD and examine whether intradermal acupuncture reduces side effects and improves the efficacy of SSRIs for MDD.
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, Randomized Controlled Trial, Adolescent
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. 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 40 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 40 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)
SSRI
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
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
[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 Patient Health Questionaire-9 (PHQ-9)
Description
The PHQ-9 was used to screen survey respondents for depression. The scale was developed according to the criteria for diagnosing depression in the American Diagnostic and Statistical Manual of Mental Disorders (4th edition) and is a concise, validated self-assessment and screening tool for depression. There are 9 questions, each with a score of 0-3 (none: 0; a few days: 1; more than half the time: 2; almost every day: 3), for a total score of 0-27.
Time Frame
Baseline, 3 weeks after treatment, 6 weeks after treatment, at 4-week follow-up
Title
Changes in the Short Form 36 Questionnaire（SF-36）
Description
The SF-36 scale has been developed by the American Medical Research Group as a universal scale for measuring quality of life and is widely recognized and used internationally. This scale has 8 dimensions to evaluate health-related quality of life, which are divided into two major categories: physical function (PF), physical function (RP), somatic pain (BP), general health (GH), energy (VT), social function (SF), emotional function (RE), and mental health (MH). the SF-36 scale is to a certain extent a better response to patients' quality of life.
Time Frame
Baseline, 3 weeks after treatment, 6 weeks after treatment, at 4-week follow-up
10. Eligibility
Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients diagnosed with MDD according to the International Classification of Disease-10 (ICD-10); HAMD-17≥7
Aged between 12 and 17 years (no limitation on gender);
Take SSRI for at least two weeks;
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
Nisang Chen
Phone
+8615990031347
Email
237247256@qq.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
Nisang Chen
Phone
+8615990031347
Email
237247256@qq.com
12. IPD Sharing Statement
Learn more about this trial
Intradermal Acupuncture Versus Sham Acupuncture and SSRI for Treating Adolescents With Major Depressive Disorder
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