The Efficacy and Cerebral Mechanism of Intradermal Acupuncture for Major Depressive Disorder: a Study Protocol for a Randomized Controlled Trial
Overview
- Phase
- Not Applicable
- Intervention
- SSRI
- Conditions
- Major Depressive Disorder
- Sponsor
- Xiaomei Shao
- Enrollment
- 120
- Locations
- 1
- Primary Endpoint
- Changes in the Hamilton Depression Scale-17 (HAMD-17) Scores
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
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) .
Detailed Description
A total of 120 patients with MDD who meet the inclusion criteria will be included in the study. 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 will assess the efficacy and safety of intradermal acupuncture for MDD. In addition, investigator will explore the possible cerebral mechanisms by which IA exerts its antidepressant effects.
Investigators
Xiaomei Shao
Professor
The Third Affiliated hospital of Zhejiang Chinese Medical University
Eligibility Criteria
Inclusion Criteria
- •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.
Exclusion Criteria
- •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;
- •Acute suicidal tendency;
- •Allergy to adhesive tape and fear of intradermal acupuncture;
- •Pregnancy and lactation;
- •Mental retardation and difficulty cooperating with doctors.
- •Participating in other clinical trials.
Arms & Interventions
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. At the end of this trial, patients could choose 6 weeks' intradermal acupuncture treatments free of charge.
Intervention: SSRI
SIA group
This group will include 40 patients with MDD who will be treated with sham intradermal acupuncture (SIA) combined with SSRIs. Acupoints related to MDD will be stimulated by acupuncturists and the dosage of oral SSRIs will be determined by the psychiatrist.
Intervention: SSRI
SIA group
This group will include 40 patients with MDD who will be treated with sham intradermal acupuncture (SIA) combined with SSRIs. Acupoints related to MDD will be stimulated by acupuncturists and the dosage of oral SSRIs will be determined by the psychiatrist.
Intervention: SIA
AIA group
This group will include 40 patients with MDD who will be treated with active intradermal acupuncture (AIA) combined with SSRIs. Acupoints related to MDD will be stimulated by acupuncturists and the dosage of oral SSRIs will be determined by the psychiatrist.
Intervention: SSRI
AIA group
This group will include 40 patients with MDD who will be treated with active intradermal acupuncture (AIA) combined with SSRIs. Acupoints related to MDD will be stimulated by acupuncturists and the dosage of oral SSRIs will be determined by the psychiatrist.
Intervention: AIA
Outcomes
Primary Outcomes
Changes in the Hamilton Depression Scale-17 (HAMD-17) Scores
Time Frame: Baseline, 3 weeks after treatment, 6 weeks after treatment, at 4-week follow-up.
The HAMD scale is the most commonly used in the clinical assessment of depression, including 17 items. The higher the score, the more severe the depression. 0-7 means no depressive symptoms, 8-17 means mild depression, 18-24 was divided into moderate depression, and 25-52 was divided into severe depression.
Secondary Outcomes
- Changes in the Pittsburgh Sleep Quality Index (PSQI) Scores(Baseline, 3 weeks after treatment, 6 weeks after treatment, at 4-week follow-up)
- Changes in the Self-Rating Depression Scale (SDS) Scores(Baseline, 3 weeks after treatment, 6 weeks after treatment, at 4-week follow-up.)