Major Depressive DisorderNCT05832619
Intradermal Acupuncture Versus Sham Acupuncture and SSRI for Treating Adolescents With Major Depressive Disorder
A study testing SSRI, SIA and AIA in people with Major Depressive Disorder, run by Xiaomei Shao at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 to 17 years
- Conditions the study is for
- Major Depressive Disorder
- What is being tested?
- SSRI, SIA and AIA
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 1 siteChina
- Study dates
- 1 Nov 2022to 30 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
the Third affiliated hospital of Zhejiang Chinese Medical university
Hangzhou, Zhejiang
Xiaomei Shao, +8618957130287, shaoxiaomei@zcmu.edu.cn
Nisang Chen, +8615990031347, 237247256@qq.com
About this study
Official title: Intradermal Acupuncture Versus Sham Acupuncture and SSRI for Treating Adolescents With Major Depressive Disorder: a Study Protocol for a Randomized Controlled Trial
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.
Read the 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.
- Conditions
- Major Depressive Disorder
- Being tested
- SSRI, SIA, AIA
- Keywords
- Major Depressive Disorder, Intradermal Acupuncture, Randomized Controlled Trial, Adolescent
- Medical subject headings
- Depressive Disorder, Major
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SSRIDrug
Also called selective 5-hydroxytryptamine reuptake inhibitors
SSRIs antidepressants, including fluoxetine, paroxetine, sertraline, citalopram, etc., will be administered at oral doses determined by the psychiatrist. Once daily for 6 weeks.
SIADevice
Also called sham intradermal acupuncture
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.
AIADevice
Also called active intradermal acupuncture
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.
| Study group | Role | What they receive |
|---|---|---|
| Waiting list group | Other | 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. Receives: Drug: SSRI |
| SIA+SSRIs group | Sham comparator | 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. Receives: Drug: SSRI; Device: SIA |
| AIA+SSRIs group | Experimental | 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. Receives: Drug: SSRI; Device: AIA |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: [Time Frame: Baseline, 3 weeks after treatment, 6 weeks after treatment, at 4-week follow-up.]
Secondary outcomes (4)
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.
Measured: Baseline, 3 weeks after treatment, 6 weeks after treatment, at 4-week follow-up
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.
Measured: Baseline, 3 weeks after treatment, 6 weeks after treatment, at 4-week follow-up
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.
Measured: Baseline, 3 weeks after treatment, 6 weeks after treatment, at 4-week follow-up
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.
Measured: Baseline, 3 weeks after treatment, 6 weeks after treatment, at 4-week follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2023
- Study start1 Nov 2022
- Primary completion30 Dec 2025 (estimated)
- Study completion30 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Major Depressive DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xiaomei Shao
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Xiaomei Shao, The Third Affiliated hospital of Zhejiang Chinese Medical University
- Investigators
- Xiaomei Shao, Ph.D, Principal investigator, The Third Affiliated hospital of Zhejiang Chinese Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05832619
- Sponsor's protocol ID
- 2022ZX010-YA
- Status last verified
- Apr 2023
- First submitted
- 15 Apr 2023
- Last updated
- 27 Apr 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Chen N, Wu X, Tu M, Xiong S, Jin J, Qu S, Pei S, Fang J, Shao X. Optimizing Treatment for Major Depressive Disorder in Adolescents: The Impact of Intradermal Acupuncture - A Randomized Controlled Trial Protocol. Neuropsychiatr Dis Treat. 2023 Aug 23;19:1819-1832. doi: 10.2147/NDT.S420489. eCollection 2023.
PubMed 37641586
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intradermal Acupuncture Versus Sham Acupuncture and SSRI for Treating Adolescents With Major Depressive Disorder: a Study Protocol for a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05832619
- Acronym / sponsor ID
- 2022ZX010-YA
- Conditions
- Major Depressive Disorder
- Keywords
- Major Depressive Disorder, Intradermal Acupuncture, Randomized Controlled Trial, Adolescent
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Xiaomei ShaoUniversity, hospital or other
- Study start
- 1 Nov 2022 (actual)
- Primary completion
- 30 Dec 2025 (estimated)
- Study completion
- 30 Dec 2025 (estimated)
- First posted
- 27 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Waiting list group | Other | Drug: SSRIThis 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. |
| SIA+SSRIs group | Sham comparator | Drug: SSRI, Device: SIAThis 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. |
| AIA+SSRIs group | Experimental | Drug: SSRI, Device: AIAThis 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. |
Who may qualify
- Ages
- 12 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (7 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SSRIAlso: selective 5-hydroxytryptamine reuptake inhibitorsSSRIs antidepressants, including fluoxetine, paroxetine, sertraline, citalopram, etc., will be administered at oral doses determined by the psychiatrist. Once daily for 6 weeks. | Drug | AIA+SSRIs group, SIA+SSRIs group, Waiting list group |
| SIAAlso: sham intradermal acupunctureThis 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. | Device | SIA+SSRIs group |
| AIAAlso: active intradermal acupunctureThis 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. | Device | AIA+SSRIs group |
Primary outcome
Changes in the Hamilton Depression Scale-17 (HAMD-17) Scores
Time frame: [Time Frame: Baseline, 3 weeks after treatment, 6 weeks after treatment, at 4-week follow-up.]
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.
4 secondary outcomes
Changes in the Self-Rating Depression Scale (SDS) Scores
Time frame: Baseline, 3 weeks after treatment, 6 weeks after treatment, at 4-week follow-up
Changes in the Pittsburgh Sleep Quality Index (PSQI) Scores
Time frame: Baseline, 3 weeks after treatment, 6 weeks after treatment, at 4-week follow-up
Changes in the Patient Health Questionaire-9 (PHQ-9)
Time frame: Baseline, 3 weeks after treatment, 6 weeks after treatment, at 4-week follow-up
Changes in the Short Form 36 Questionnaire（SF-36）
Time frame: Baseline, 3 weeks after treatment, 6 weeks after treatment, at 4-week follow-up
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2023.
- Derived from this study: PubMed 37641586Chen N, Wu X, Tu M, Xiong S, Jin J, Qu S, Pei S, Fang J, Shao X. Optimizing Treatment for Major Depressive Disorder in Adolescents: The Impact of Intradermal Acupuncture - A Randomized Controlled Trial Protocol. Neuropsychiatr Dis Treat. 2023 Aug 23;19:1819-1832. doi: 10.2147/NDT.S420489. eCollection 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Xiaomei Shao, Ph.D principal investigator
The Third Affiliated hospital of Zhejiang Chinese Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SSRI, SIA and AIA in people with Major Depressive Disorder, run by Xiaomei Shao at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Xiaomei Shao, Ph.D (+8618957130287, shaoxiaomei@zcmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in the Hamilton Depression Scale-17 (HAMD-17) Scores (time frame: [Time Frame: Baseline, 3 weeks after treatment, 6 weeks after treatment, at 4-week follow-up.]). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05832619, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Apr 2023.