Using intradermal acupuncture to treat depression in adolescents
Intradermal Acupuncture Versus Sham Acupuncture and SSRI for Treating Adolescents With Major Depressive Disorder: a Study Protocol for a Randomized Controlled Trial
This study is testing if adding intradermal acupuncture to standard antidepressant treatment can help teenagers with depression feel better and have fewer side effects.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 120 (estimated) |
| Ages | 12 Years to 17 Years |
| Sex | All |
| Sponsor | The Third Affiliated hospital of Zhejiang Chinese Medical University Academic / other |
| Locations | 1 site (Hangzhou, Zhejiang) |
| Trial ID | NCT05832619 on ClinicalTrials.gov |
What this trial studies
This study investigates the effectiveness of intradermal acupuncture in treating adolescents diagnosed with major depressive disorder (MDD). A total of 120 participants aged 12 to 17 will be randomly assigned to one of three groups: a waiting list group receiving only SSRIs, a sham acupuncture group receiving SSRIs, or an active acupuncture group also receiving SSRIs. The aim is to evaluate whether intradermal acupuncture can enhance the efficacy of SSRIs and reduce their side effects. The study will utilize a randomized controlled trial design to ensure robust results.
Who should consider this trial
Good fit: Ideal candidates are adolescents aged 12 to 17 diagnosed with major depressive disorder who have been on SSRIs for at least two weeks.
Not a fit: Patients with other psychiatric disorders, severe medical conditions, or acute suicidal tendencies may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could provide a novel treatment option that enhances the effectiveness of SSRIs while minimizing side effects for adolescents with MDD.
How similar studies have performed: Previous studies have shown promising results for acupuncture in treating depression, suggesting that this approach may be effective, though the specific use of intradermal acupuncture in adolescents is less commonly tested.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Hangzhou, Zhejiang
- the Third affiliated hospital of Zhejiang Chinese Medical university — Hangzhou, Zhejiang, China (Recruiting)
Study contacts
- Principal investigator: Xiaomei Shao, Ph.D — The Third Affiliated hospital of Zhejiang Chinese Medical University
- Study coordinator: Xiaomei Shao, Ph.D
- Email: shaoxiaomei@zcmu.edu.cn
- Phone: +8618957130287
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.