Clinical Efficacy of Electroacupuncture for Generalized Anxiety Disorder and Its Central Mechanism Based on Neuroimaging Changes
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 123
- 主要终点
- Effective rate of HAMA score reduction at Week 4
研究概览
简要总结
This study aims to evaluate the clinical efficacy and safety of electroacupuncture (EA) in treating Generalized Anxiety Disorder (GAD). Participants will be randomly assigned to an EA group, a sham EA group, or a waiting-list control group. All participants will continue their routine medication (Paroxetine). The primary goal is to observe the reduction in anxiety symptoms using the Hamilton Anxiety Scale (HAMA). Additionally, the study will use functional MRI (fMRI) and Magnetic Resonance Spectroscopy (MRS) to explore the brain mechanisms through which EA helps alleviate anxiety.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Meet the DSM-5 diagnostic criteria for Generalized Anxiety Disorder (GAD).
- •No antidepressant or anti-anxiety medication in the past 2 weeks.
- •HAMA score ≥
- •Right-handed（for MRI).
- •Aged 18-60 years, with at least primary school education.
- •Signed informed consent.
排除标准
- •Complicated with severe cardiovascular, cerebrovascular, or organic diseases.
- •History of other psychiatric disorders (e.g., schizophrenia, bipolar disorder).
- •Contraindications for MRI (e.g., metal implants, claustrophobia).
- •Pregnancy or lactation.
研究组 & 干预措施
Electroacupuncture (EA) Group
Paroxetine Hydrochloride Tablets + Electroacupuncture
干预措施: Electroacupuncture (EA) (Procedure)
Electroacupuncture (EA) Group
Paroxetine Hydrochloride Tablets + Electroacupuncture
干预措施: Routine Medication (Drug)
Sham Electroacupuncture (SEA) Group
Paroxetine Hydrochloride Tablets + Sham Electroacupuncture
干预措施: Sham Electroacupuncture (SEA) (Procedure)
Sham Electroacupuncture (SEA) Group
Paroxetine Hydrochloride Tablets + Sham Electroacupuncture
干预措施: Routine Medication (Drug)
Waiting-list (WL) Group
Paroxetine Hydrochloride Tablets + Delayed EA Treatment
干预措施: Routine Medication (Drug)
结局指标
主要结局
Effective rate of HAMA score reduction at Week 4
时间窗: Week 4 (at the end of treatment)
The percentage of participants who achieved a HAMA score reduction rate of ≥50% from baseline. HAMA scores are evaluated to categorize outcomes as recovered, markedly effective, effective, or ineffective.
次要结局
- Change from Baseline in Hamilton Anxiety Scale (HAMA) Scores(Baseline, Week 2, Week 4, and Week 8)
- Change from Baseline in Social Disability Screening Schedule (SDSS) Scores(Baseline, Week 2, Week 4, and Week 8)
- Frequency of Participants with Changes in Paroxetine Dosage(Week 2, Week 4, and Week 8)
- Treatment Emergent Symptom Scale (TESS) Scores(Week 2, Week 4, and Week 8)
- Changes in Functional Connectivity (FC), Regional Homogeneity (ReHo), and Amplitude of Low-Frequency Fluctuation (ALFF)(Baseline and Week 4)
- Changes in Brain Metabolite Concentrations via Magnetic Resonance Spectroscopy (MRS)(Baseline and Week 4)
研究者
Lishu Gao
Associate Chief Physician
First People's Hospital of Hangzhou