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

Xiaomei Shao

Status: Enrolling

Conditions: Major Depressive Disorder

Treatments: Device: AIA; Drug: SSRI; Device: SIA

Study type: Interventional

Funder types: Other

Identifiers

NCT05832619

2022ZX010-YA

Details and patient eligibility

About

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.

Full description

This study will enroll a total of 120 adolescents with MDD who meet the inclusion criteria. 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 is aim to evaluate the efficacy of intradermal acupuncture for MDD and examine whether intradermal acupuncture reduces side effects and improves the efficacy of SSRIs for MDD.

Enrollment: 120 estimated patients

Sex: All

Ages: 12 to 17 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Patients diagnosed with MDD according to the International Classification of Disease-10 (ICD-10); HAMD-17≥7
2. Aged between 12 and 17 years (no limitation on gender);
3. Take SSRI for at least two weeks;
4. 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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120 participants in 3 patient groups

Waiting list group

Other group

Description:

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.

Treatment:

Drug: SSRI

SIA+SSRIs group

Sham Comparator group

Description:

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.

Treatment:

Device: SIA

Drug: SSRI

AIA+SSRIs group

Experimental group

Description:

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.

Treatment:

Drug: SSRI

Device: AIA