Efficacy and Safety of Intradermal Acupuncture for Major Depressive Disorder

Xiaomei Shao

Status: Enrolling

Conditions: Major Depressive Disorder

Treatments: Procedure: SIA; Drug: SSRIs; Procedure: AIA

Study type: Interventional

Funder types: Other

Identifiers

NCT05605002

2022ZX010-INM

Details and patient eligibility

About

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.

Full description

A total of 90 patients with MDD who meet the inclusion criteria will be included in the study. 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 will assess the efficacy and safety of intradermal acupuncture for MDD and examine whether intradermal acupuncture reduces side effects and improves the efficacy of SSRIs for MDD. In addition, the study will use magnetic resonance imaging (MRI) to study the possible central mechanisms by which intradermal acupuncture exerts its antidepressant effects.

Enrollment: 90 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Patients diagnosed with MDD according to the International Classification of Disease-10 (ICD-10);
2. Aged between 18 and 60 years (no limitation on gender);
3. No depression-related treatment in the past two weeks, except SSRIs;
4. Patients undergoing MRI and MRS should be right-handed and free of traumatic brain injury, claustrophobia or metal implants;
5. Written informed consent is obtained by the person or guardian.

Exclusion criteria

1. ICD-10 diagnoses: schizophrenia, bipolar disorder, manic episode or other psychotic disorders; alcohol and drug addiction;
2. Significant skin lesions, severe allergic diseases, tumors, and severe or unstable internal diseases involving the cardiovascular, digestive, endocrine, or hematological system;
3. Acute suicidal tendency;
4. Allergy to adhesive tape and fear of intradermal acupuncture;
5. Pregnancy and lactation;
6. Mental retardation and difficult to cooperate with doctors.
7. Participating in other clinical trials.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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90 participants in 3 patient groups

Waiting list group

Active Comparator group

Description:

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.

Treatment:

Drug: SSRIs

SIA+SSRIs group

Sham Comparator group

Description:

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.

Treatment:

Drug: SSRIs

Procedure: SIA

AIA+SSRIs group

Experimental group

Description:

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.

Treatment:

Procedure: AIA

Drug: SSRIs