Intradermal Acupuncture Versus Sham Acupuncture and SSRI for Treating Adolescents With Major Depressive Disorder

NCT05832619 | Unknown

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

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.

Conditions

Major Depressive Disorder

Keywords

Major Depressive Disorder; Intradermal Acupuncture; Randomized Controlled Trial; Adolescent

Outcome Measures

Primary Outcomes (1)

• 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.

  [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

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

• Changes in the Pittsburgh Sleep Quality Index (PSQI) Scores

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

• Changes in the Patient Health Questionaire-9 (PHQ-9)

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

• Changes in the Short Form 36 Questionnaire（SF-36）

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

Study Arms (3)

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.

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.

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.

Drug: SSRI; Device: AIA

Interventions

SSRI DRUG

SSRIs antidepressants, including fluoxetine, paroxetine, sertraline, citalopram, etc., will be administered at oral doses determined by the psychiatrist. Once daily for 6 weeks.

Also known as: selective 5-hydroxytryptamine reuptake inhibitors

AIA+SSRIs group; SIA+SSRIs group; Waiting list group

SIA DEVICE

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.

Also known as: sham intradermal acupuncture

SIA+SSRIs group

AIA DEVICE

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.

Also known as: active intradermal acupuncture

AIA+SSRIs group

Eligibility Criteria

• Age: 12 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Xiaomei Shao: lead

Study Sites (1)

the Third affiliated hospital of Zhejiang Chinese Medical university

Hangzhou, Zhejiang, China

RECRUITING

Related Publications (1)

• 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.

  PMID: 37641586 DERIVED

MeSH Terms

Conditions

Depressive Disorder, Major

Interventions

Selective Serotonin Reuptake Inhibitors

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

Study Officials

• Xiaomei Shao, Ph.D

  The Third Affiliated hospital of Zhejiang Chinese Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xiaomei Shao, Ph.D

CONTACT

+8618957130287; shaoxiaomei@zcmu.edu.cn

Nisang Chen

CONTACT

+8615990031347; 237247256@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: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 15, 2023
• First Posted: April 27, 2023
• Study Start: November 1, 2022
• Primary Completion: December 30, 2025
• Study Completion: December 30, 2025
• Last Updated: April 27, 2023

Record last verified: 2023-04

Locations

CN (1)