Efficacy and Safety of Intradermal Acupuncture for Major Depressive Disorder

NCT05605002 | Unknown

• 1 other identifier: 2022ZX010-INM
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

Major depressive disorder (MDD) is a common mental illness that severely affects the health and quality of life of patients. Treatment with acupuncture alone or a combination of appropriate adjuncts has been reported to be significantly effective in reducing the severity of MDD, relieving patients' somatic symptoms and improving sleep. This study will focus on the intradermal acupuncture, which is more convenient, gentler and has longer lasting effects. The aim is to study the efficacy and safety of intradermal acupuncture for MDD, and to preliminarily explore the central nervous mechanisms by which it exerts its therapeutic effects.

Conditions

Major Depressive Disorder

Keywords

Major Depressive Disorder; Intradermal Acupuncture; Magnetic Resonance Imaging

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.

  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 Treatment Emergent Symptom Scale (TESS) Scores

  Baseline, 6 weeks after treatment

• Adverse Events

  Up to 10 weeks

Other Outcomes (3)

• Magnetic resonance imaging (MRI) data acquisition

  Baseline, 6 weeks after treatment

• Magnetic resonance spectroscopy (MRS ) data acquisition

  Baseline, 6 weeks after treatment

• Blood samples biobank establishment

  Baseline, 6 weeks after treatment

Study Arms (3)

Waiting list group

ACTIVE COMPARATOR

This group will include 30 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: SSRIs

SIA+SSRIs group

SHAM COMPARATOR

This group will include 30 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: SSRIs; Procedure: SIA

AIA+SSRIs group

EXPERIMENTAL

This group will include 30 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: SSRIs; Procedure: AIA

Interventions

SSRIs 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 PROCEDURE

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 PROCEDURE

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: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Patients diagnosed with MDD according to the International Classification of Disease-10 (ICD-10);
• Aged between 18 and 60 years (no limitation on gender);
• No depression-related treatment in the past two weeks, except SSRIs;
• Patients undergoing MRI and MRS should be right-handed and free of traumatic brain injury, claustrophobia or metal implants;
• 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
• Zhejiang Provincial Tongde Hospital: collaborator
• First People's Hospital of Hangzhou: collaborator
• The First Affiliated Hospital of Zhejiang Chinese Medical University: collaborator

Study Sites (1)

the Third affiliated hospital of Zhejiang Chinese Medical university

Hangzhou, Zhejiang, China

RECRUITING

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

Xiaoting Wu

CONTACT

+8618196671636; xiaotwu@163.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: August 31, 2022
• First Posted: November 3, 2022
• Study Start: January 1, 2022
• Primary Completion: December 30, 2025
• Study Completion: December 30, 2025
• Last Updated: November 3, 2022

Record last verified: 2022-11

Locations

CN (1)