Intradermal Acupuncture Versus Sham Acupuncture and SSRI for Treating Adolescents With Major Depressive Disorder: a Study Protocol for a Randomized Controlled Trial

Status: Recruiting
Location: See location...
Intervention Type: Device, Drug
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 12
Maximum Age: 17
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
China
the Third affiliated hospital of Zhejiang Chinese Medical university
RECRUITING
Hangzhou
Contact Information
Primary
Xiaomei Shao, Ph.D
shaoxiaomei@zcmu.edu.cn
+8618957130287
Backup
Nisang Chen
237247256@qq.com
+8615990031347
Time Frame
Start Date: 2022-11-01
Estimated Completion Date: 2025-12-30
Participants
Target number of participants: 120
Treatments
Other: Waiting list group
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.
Sham_comparator: SIA+SSRIs group
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.
Experimental: AIA+SSRIs group
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.
Related Therapeutic Areas
Sponsors
Leads: Xiaomei Shao

This content was sourced from clinicaltrials.gov

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