Intradermal Needle Therapy for Major Depressive Disorder

NCT05352113 | Unknown

• 1 other identifier: 2022ZX010-MDD
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Major Depressive Disorder

Keywords

Major Depressive Disorder; Acupuncture; Randomized controlled clinical trial

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Change in the Treatment Emergent SymptomScale (TESS)

  Baseline, 3 weeks after treatment, 6 weeks after treatment, at 4-week follow-up.

• Change in the MOS item short from health survey (SF-36)

  Baseline, 3 weeks after treatment, 6 weeks after treatment, at 4-week follow-up.

• Change in the Pittsburgh Sleep Quality Index (PSQI)

  Baseline, 3 weeks after treatment, 6 weeks after treatment, at 4-week follow-up.

Study Arms (3)

acupuncture + SSRIs group

EXPERIMENTAL

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.

Drug: SSRIs; Procedure: acupuncture

acupuncture + placebo group

EXPERIMENTAL

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.

Procedure: acupuncture; Drug: placebo

sham acupuncture + SSRIs group

EXPERIMENTAL

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.

Drug: SSRIs; Procedure: sham acupuncture

Interventions

SSRIs DRUG

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

Also known as: SSRIs antidepressants

acupuncture + SSRIs group; sham acupuncture + SSRIs group

acupuncture PROCEDURE

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.

Also known as: intradermal needle

acupuncture + SSRIs group; acupuncture + placebo group

sham acupuncture PROCEDURE

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.

Also known as: sham intradermal needle

sham acupuncture + SSRIs group

placebo DRUG

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

Also known as: placebo mimicking SSRIs antidepressants

acupuncture + placebo group

Eligibility Criteria

• Age: 12 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• \. 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).

You may not qualify if:

• \. 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.

Sponsors & Collaborators

• The Third Affiliated hospital of Zhejiang Chinese Medical University: lead
• The Zhejiang Provincial Tongde Hospital: collaborator
• The Affiliated Hangzhou First People's Hospital: collaborator

Study Sites (1)

Xiaomei Medical Shao

Hangzhou, Zhejiang, China

Location

MeSH Terms

Conditions

Depressive Disorder, Major

Interventions

Selective Serotonin Reuptake Inhibitors; Acupuncture Therapy

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Neurotransmitter Uptake Inhibitors; Membrane Transport Modulators; Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Neurotransmitter Agents; Serotonin Agents; Physiological Effects of Drugs; Complementary Therapies; Therapeutics

Study Officials

• Xiaomei M Shao, Ph.D

  The Third Affiliated hospital of Zhejiang Chinese Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xiaomei M Shao, Ph.D

CONTACT

+8618957130287; shaoxiaomei@zcmu.edu.cn

Mingqi Tu

CONTACT

+8615700067213; 403712321@qq.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof

Study Record Dates

• First Submitted: April 27, 2022
• First Posted: April 28, 2022
• Study Start: May 1, 2022
• Primary Completion: May 1, 2025
• Study Completion: December 30, 2025
• Last Updated: April 28, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)