Intradermal Needle Therapy for Major Depressive Disorder

Major Depressive Disorder Clinical Trial

Official title:

Intradermal Needle Therapy for Major Depressive Disorder

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05352113
• Other study ID #: 2022ZX010-MDD
• Status: Not yet recruiting
• Phase: N/A
• Start date: May 1, 2022
• Est. completion date: December 30, 2025

Study information

• Verified date: April 2022
• Source: The Third Affiliated hospital of Zhejiang Chinese Medical University
• Contact: Xiaomei M Shao, Ph.D
• Phone: +8618957130287
• Email: shaoxiaomei[@]zcmu.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 120
• Est. completion date: December 30, 2025
• Est. primary completion date: May 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Disease
• Major Depressive Disorder

Intervention

Drug:
• SSRIs
SSRIs antidepressants will be used and the oral dose will be determined by the clinical specialist. Once-daily for 6 weeks.

Procedure:
• acupuncture
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 f0.20*1.5m or f0.20*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.
• sham acupuncture
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.

Drug:
• placebo
Oral placebo mimicking SSRIs antidepressants. Once-daily for 6 weeks.

Locations

Country	Name	City	State
China	Xiaomei Medical Shao	Hangzhou	Zhejiang

Sponsors (3)

Lead Sponsor	Collaborator
The Third Affiliated hospital of Zhejiang Chinese Medical University	The Affiliated Hangzhou First People's Hospital, The Zhejiang Provincial Tongde Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Baseline, 3 weeks after treatment, 6 weeks after treatment, at 4-week follow-up.
Secondary	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.	Baseline, 3 weeks after treatment, 6 weeks after treatment, at 4-week follow-up.
Secondary	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).	Baseline, 3 weeks after treatment, 6 weeks after treatment, at 4-week follow-up.
Secondary	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.	Baseline, 3 weeks after treatment, 6 weeks after treatment, at 4-week follow-up.