Intradermal acupuncture for treating major depressive disorder
Efficacy and Safety of Intradermal Acupuncture for Major Depressive Disorder: a Study Protocol for a Multicenter, Prospective, Randomized Controlled Trial
This study is testing if adding intradermal acupuncture to standard depression medication can help people with major depressive disorder feel better and experience fewer side effects.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 90 (estimated) |
| Ages | 18 Years to 60 Years |
| Sex | All |
| Sponsor | The Third Affiliated hospital of Zhejiang Chinese Medical University Academic / other |
| Locations | 1 site (Hangzhou, Zhejiang) |
| Trial ID | NCT05605002 on ClinicalTrials.gov |
What this trial studies
This study investigates the efficacy and safety of intradermal acupuncture as a treatment for major depressive disorder (MDD). A total of 90 patients diagnosed with MDD will be randomly assigned to one of three groups: a waiting list group receiving SSRIs only, a sham acupuncture group combined with SSRIs, and an active acupuncture group combined with SSRIs. The study aims to determine if intradermal acupuncture can enhance the effectiveness of SSRIs and reduce their side effects. Additionally, magnetic resonance imaging (MRI) will be utilized to explore the central nervous mechanisms involved in the therapeutic effects of acupuncture.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 to 60 diagnosed with major depressive disorder who have not received depression-related treatment in the past two weeks.
Not a fit: Patients with other psychiatric disorders, severe medical conditions, or those who are pregnant or lactating may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could provide a novel and effective treatment option for patients suffering from major depressive disorder.
How similar studies have performed: Previous studies have shown promising results for acupuncture in treating depression, but the specific use of intradermal acupuncture is a novel approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
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.