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NCT Number: NCT05720637

The Efficacy and Cerebral Mechanism of Intradermal Acupuncture for Major Depressive Disorder

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) .

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Key information

Conditions

Major Depressive Disorder Depressive Disorder Depressive Disorder, Major Mental Disorders Mood Disorders

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

the Third affiliated hospital of Zhejiang Chinese Medical university [Recruiting]

Hangzhou, Zhejiang, China

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

SSRI

Drug

SSRIs antidepressants, including fluoxetine, paroxetine, sertraline, citalopram, etc., will be administered at oral doses determined by the psychiatrist. Once daily for the duration of the trial.

Other names: selective 5-hydroxytryptamine reuptake inhibitor

SIA

Device

This study will select 4 acupoints (all taken bilaterally) commonly used to treat MDD, namely Taichong (LR3), Neiguan (PC6), Sanyinjiao (SP6) and Shenmen (HT7). The SIA will use the same size, colour and material as the AIA with a thin silicone pad in the middle instead of the needle body. SIA will be attached to the acupoints and retained for 72 hours, removed and rested for one day. A total of 10 sessions will be performed over a period of 6 weeks.

Other names: sham intradermal acupuncture

AIA

Device

This study will select 4 acupoints (all taken bilaterally) commonly used to treat MDD, namely Taichong (LR3), Neiguan (PC6), Sanyinjiao (SP6) and Shenmen (HT7). Depending on acupoints' location, a φ0.20*1.5mm or φ0.20*1.2mm AIA will be selected. Press the AIA to insert it vertically into the acupoint and retain it in the skin. AIA will be retained for 72 hours with a day's rest after removal. During the period of needle retention, participants will be instructed to press the AIA 3-4 times a day for approximately 1 minute each time, with as much stimulation as the patient can tolerate, at intervals of approximately 4 hours. A total of 10 sessions will be performed over a period of 6 weeks.

Other names: active intradermal acupuncture

Primary outcomes

  1. 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

  1. Changes in the Self-Rating Depression Scale (SDS) Scores

    Time frame: Baseline, 3 weeks after treatment, 6 weeks after treatment, at 4-week follow-up.

    The standard score is the total of all scores multiplied by 1.25 to the nearest whole number on this scale, which has 20 questions. A standard score below 50 is normal; 50-60 is mild depression; 61-70 is moderate depression; 70 or more is severe depression.

  2. Changes in the Pittsburgh Sleep Quality Index (PSQI) Scores

    Time frame: Baseline, 3 weeks after treatment, 6 weeks after treatment, at 4-week follow-up

    The PSQI is used to assess the sleep quality of the participant in the last 1 month and consisted of 19 self-rated and 5 other rated items. The higher the score, the worse the sleep quality. Sleep quality is divided into 4 levels according to the total score.

Other outcomes

  1. Magnetic resonance imaging (MRI) data acquisition

    Time frame: Baseline

    Brain MRI will be taken by a 3.0T MRI scanner to analyze the activity function of brain regions, such as the striatum and ventral tegmental area, before and after the acupuncture intervention of patients, and at the baseline of heath controls.

  2. Evaluation of acupuncture compliance

    Time frame: 6 weeks after treatment

    At the end of the acupuncture intervention (end of week 6), compliance will be evaluated with the formula: Compliance Rate = (actual treatment times/total treatment times) *100%.

  3. Adverse Events

    Time frame: Up to 10 weeks

    Adverse events such as bleeding, haematoma, or unbearable pain caused by the needle, as well as drug-induced nausea, vomiting or dizziness, will all be recorded.

Sponsors and collaborators

Lead sponsor

Xiaomei Shao

Other

Collaborators

  • First People's Hospital of Hangzhou
  • The First Affiliated Hospital of Zhejiang Chinese Medical University
  • Zhejiang Provincial Tongde Hospital

Registry information

Official study title

The Efficacy and Cerebral Mechanism of Intradermal Acupuncture for Major Depressive Disorder: a Study Protocol for a Randomized Controlled Trial

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Feb 9, 2023
Registry last updated
Feb 20, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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