NCT05720637Completed
The Efficacy and Cerebral Mechanism of Intradermal Acupuncture for Major Depressive Disorder
The Efficacy and Cerebral Mechanism of Intradermal Acupuncture for Major Depressive Disorder: a Study Protocol for a Randomized Controlled Trial
Source: ClinicalTrials.gov · Last updated 20 Feb 2024
Brief summary (registry, in English)
Major depressive disorder (MDD) is highly prevalent, affecting nearly 4% of the global population. Pharmacotherapy is the frontline treatment recommended by the guideline, but it also has some limitations such as delayed onset, inadequate response, and drug resistance. Intradermal acupuncture (IA) is a method of using short indwelling needles retained under the skin to produce continuous stimulation for long-term efficacy. It has been reported that IA combination medication appears to be more valuable than medication alone in the treatment of MDD, however, there is a lack of high-quality clinical evidence.While several studies have proposed that manual or electroacupuncture can improve MDD symptoms by modulating brain networks, the cerebral mechanism of IA as superficial acupuncture for MDD has not been reported. Hence, investigators designed a multicentre randomized controlled trial to assess the clinical efficacy and safety of IA for MDD and preliminarily explore the potential therapeutic mechanisms for IA by functional magnetic resonance imaging (fMRI) .
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 120 (actual)
- First submitted
- 31 Jan 2023
- Start date
- 1 Nov 2022
- Primary completion date
- 1 Jan 2024
- Lead sponsor
- Xiaomei Shao
- Diseases
- Depression
- NCT number
- NCT05720637
What you commit to
- Study type: Interventional
- Participants enrolled: 120
- From 1 Nov 2022 to the primary completion date, 1 Jan 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- ICD-10 diagnoses: schizophrenia, bipolar disorder, manic episode or other psychotic disorders; alcohol and drug addiction;
- Significant skin lesions, severe allergic diseases, tumors, and severe or unstable internal diseases involving the cardiovascular, digestive, endocrine, or hematological system;
- Allergy to adhesive tape and fear of intradermal acupuncture;
Other
- Acute suicidal tendency;
- Pregnancy and lactation;
- Mental retardation and difficulty cooperating with doctors.
- Participating in other clinical trials.
Who the study is looking for
- Patients diagnosed with MDD according to the International Classification of Disease-10 (ICD-10);
- Aged between 18 and 60 years (no limitation on gender);
- Administration of SSRIs;
- Patients undergoing MRI and MRS should be right-handed and free of traumatic brain injury, claustrophobia or metal implants;
- Written informed consent is obtained by the person or guardian.
Age in the registry: 18 years to 60 years · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| the Third affiliated hospital of Zhejiang Chinese Medical university [Recruiting] Coordinator of this site? Confirm its status | Hangzhou | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.