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Intradermal Needle Therapy for Major Depressive Disorder

Primary Purpose

Major Depressive Disorder

Status
Not yet recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
SSRIs
acupuncture
sham acupuncture
placebo
Sponsored by
The Third Affiliated hospital of Zhejiang Chinese Medical University
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, Acupuncture, Randomized controlled clinical trial

Eligibility Criteria

12 Years - 60 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 1. 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; 2. 12 ≤ age ≤60, male or female; 3. Participants have clear consciousness and could communicate with others normally; 4. 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. Participants with serious primary diseases of cardiovascular, respiratory, digestive, urinary, hematological, endocrine, neurological disease, and other serious primary diseases, and the disease cannot be effectively controlled clinically; 2. Major depressive disorders caused by organic mental disorders, schizophrenia, bipolar disorder, psychoactive substances, and non-addictive substances; 3. Participants with suicidal tendencies; 4. Pregnant or lactating participants; 5. Participants taking other antidepressants that were not SSRIs or the pharmacological effects of such antidepressants have not been cleared; 6. Participants with intellectual disabilities who cannot cooperate with the questionnaire survey; 7. Participants with bleeding tendency, skin disease, allergic constitution, and allergic to adhesive tape; 8. Participants are participating in other trials.

Sites / Locations

  • Xiaomei Medical Shao

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

acupuncture + SSRIs group

acupuncture + placebo group

sham acupuncture + SSRIs group

Arm Description

This group will include 40 patients with MDD who will be treated with acupuncture and SSRIs antidepressants. Acupoints related to MDD will be stimulated. The oral dose of SSRIs antidepressants will be determined by the clinical specialist.

This group will include 40 patients with MDD who will be treated with acupuncture and a placebo. Acupoints related to MDD will be stimulated. The oral dose of SSRIs antidepressants will be determined by the clinical specialist.

This group will include 40 patients with MDD who will be treated with sham acupuncture and SSRIs antidepressants. The sham acupuncture will be needled on the points 1cm lateral to acupoints. The oral dose of SSRIs antidepressants will be determined by the clinical specialist.

Outcomes

Primary Outcome Measures

Change in the Hamilton Depression Scale-17 (HAMD-17)
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

Change in the Treatment Emergent SymptomScale (TESS)
The TESS scale rated each symptom on three dimensions: severity, the relationship between the symptom and the medication, and the measure taken.
Change in the MOS item short from health survey (SF-36)
The SF-36 scale evaluates the quality of healthy life into 8 dimensions, which are divided into two categories: physical health and mental health, namely physical function (PF), role physical (RP), body pain (BP), general health (GH), vitality (VT), social function (SF), role emotional (RE), mental health (MH).
Change in the Pittsburgh Sleep Quality Index (PSQI)
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
April 27, 2022
Last Updated
April 27, 2022
Sponsor
The Third Affiliated hospital of Zhejiang Chinese Medical University
Collaborators
The Zhejiang Provincial Tongde Hospital, The Affiliated Hangzhou First People's Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05352113
Brief Title
Intradermal Needle Therapy for Major Depressive Disorder
Official Title
Intradermal Needle Therapy for Major Depressive Disorder
Study Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
May 1, 2022 (Anticipated)
Primary Completion Date
May 1, 2025 (Anticipated)
Study Completion Date
December 30, 2025 (Anticipated)

3. Sponsor/Collaborators

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

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 disorder that affects patients' physical health and quality of life. Although traditional acupuncture therapy has certain advantages in improving MDD, there are still some limitations, such as being time-consuming and some people having a fear of acupuncture. Therefore, intradermal needle therapy will be chosen in the treatment of MDD in this study, which is more convenient, shallow needling, and gentle than traditional acupuncture therapy. The study is designed to investigate the therapeutic effect and safety of intradermal needles for MDD.
Detailed Description
A total of 120 participants with MDD who meet the inclusion criteria will be included in the study. Participants will be randomly divided into the SSRIs + acupuncture group, acupuncture + placebo group, and SSRIs + sham acupuncture group. This study will evaluate the efficacy and safety of the intradermal needle for MDD and investigate whether the intradermal needle reduces side effects and increases the efficacy of selective serotonin reuptake inhibitors (SSRIs) antidepressants for MDD. Furthermore, the study will demonstrate whether the intradermal needle has a synergistic effect with SSRIs on the treatment of 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, Acupuncture, Randomized controlled clinical trial

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
acupuncture + SSRIs group
Arm Type
Experimental
Arm Description
This group will include 40 patients with MDD who will be treated with acupuncture and SSRIs antidepressants. Acupoints related to MDD will be stimulated. The oral dose of SSRIs antidepressants will be determined by the clinical specialist.
Arm Title
acupuncture + placebo group
Arm Type
Experimental
Arm Description
This group will include 40 patients with MDD who will be treated with acupuncture and a placebo. Acupoints related to MDD will be stimulated. The oral dose of SSRIs antidepressants will be determined by the clinical specialist.
Arm Title
sham acupuncture + SSRIs group
Arm Type
Experimental
Arm Description
This group will include 40 patients with MDD who will be treated with sham acupuncture and SSRIs antidepressants. The sham acupuncture will be needled on the points 1cm lateral to acupoints. The oral dose of SSRIs antidepressants will be determined by the clinical specialist.
Intervention Type
Drug
Intervention Name(s)
SSRIs
Other Intervention Name(s)
SSRIs antidepressants
Intervention Description
SSRIs antidepressants will be used and the oral dose will be determined by the clinical specialist. Once-daily for 6 weeks.
Intervention Type
Procedure
Intervention Name(s)
acupuncture
Other Intervention Name(s)
intradermal needle
Intervention Description
This study will use the intradermal needle as an acupuncture intervention. Acupoints related to MDD 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.
Intervention Type
Procedure
Intervention Name(s)
sham acupuncture
Other Intervention Name(s)
sham intradermal needle
Intervention Description
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 MDD-related 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.
Intervention Type
Drug
Intervention Name(s)
placebo
Other Intervention Name(s)
placebo mimicking SSRIs antidepressants
Intervention Description
Oral placebo mimicking SSRIs antidepressants. Once-daily for 6 weeks.
Primary Outcome Measure Information:
Title
Change in the Hamilton Depression Scale-17 (HAMD-17)
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
Change in the Treatment Emergent SymptomScale (TESS)
Description
The TESS scale rated each symptom on three dimensions: severity, the relationship between the symptom and the medication, and the measure taken.
Time Frame
Baseline, 3 weeks after treatment, 6 weeks after treatment, at 4-week follow-up.
Title
Change in the MOS item short from health survey (SF-36)
Description
The SF-36 scale evaluates the quality of healthy life into 8 dimensions, which are divided into two categories: physical health and mental health, namely physical function (PF), role physical (RP), body pain (BP), general health (GH), vitality (VT), social function (SF), role emotional (RE), mental health (MH).
Time Frame
Baseline, 3 weeks after treatment, 6 weeks after treatment, at 4-week follow-up.
Title
Change in the Pittsburgh Sleep Quality Index (PSQI)
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.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 1. 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; 2. 12 ≤ age ≤60, male or female; 3. Participants have clear consciousness and could communicate with others normally; 4. 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. Participants with serious primary diseases of cardiovascular, respiratory, digestive, urinary, hematological, endocrine, neurological disease, and other serious primary diseases, and the disease cannot be effectively controlled clinically; 2. Major depressive disorders caused by organic mental disorders, schizophrenia, bipolar disorder, psychoactive substances, and non-addictive substances; 3. Participants with suicidal tendencies; 4. Pregnant or lactating participants; 5. Participants taking other antidepressants that were not SSRIs or the pharmacological effects of such antidepressants have not been cleared; 6. Participants with intellectual disabilities who cannot cooperate with the questionnaire survey; 7. Participants with bleeding tendency, skin disease, allergic constitution, and allergic to adhesive tape; 8. Participants are participating in other trials.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Xiaomei M Shao, Ph.D
Phone
+8618957130287
Email
shaoxiaomei@zcmu.edu.cn
First Name & Middle Initial & Last Name or Official Title & Degree
Mingqi Tu
Phone
+8615700067213
Email
403712321@qq.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xiaomei M Shao, Ph.D
Organizational Affiliation
The Third Affiliated hospital of Zhejiang Chinese Medical University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Xiaomei Medical Shao
City
Hangzhou
State/Province
Zhejiang
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xiaomei M Shao
Phone
+8618957130287
Email
shaoxiaomei@zcmu.edu.cn
First Name & Middle Initial & Last Name & Degree
Mingqi Tu
Phone
+8615700067213
Email
403712321@qq.com

12. IPD Sharing Statement

Plan to Share IPD
No

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Intradermal Needle Therapy for Major Depressive Disorder

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