Efficacy and Mechanism of Transcutaneous Vagus Nerve Stimulation in the Treatment of Generalized Anxiety Disorder
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 82
- 试验地点
- 2
- 主要终点
- Changes in the Hamilton Anxiety Scale at Baseline and Week 2 of Treatment
研究概览
简要总结
This is a randomized, double-blind, parallel-controlled study of patients with generalized anxiety disorder, who will be randomly assigned to either drug-combined transcutaneous vagus nerve stimulation (tVNS) group or drug-combined sham-stimulation group for a period of 4 weeks of treatment.Scale assessments will be performed at baseline, week 1, week 2, week 3, and week 4 of treatment, and brain function monitoring as well as laboratory tests will be performed at baseline and at the end of treatment, respectively.The aim of this study is to investigate the efficacy of medication combined with tVNS and the possible mechanisms of tVNS in the treatment of 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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Meeting DSM-5 diagnostic criteria for Generalized Anxiety Disorder;
- •Having a first episode of Generalized Anxiety Disorder or not having used an anxiolytic, antidepressant, antipsychotic, or anticonvulsant medication in the last 1 month.
- •Having a Hamilton Anxiety Scale (HAMA) score of more than 14 and a Hamilton Depression Scale (HAMD-17) score of less than 17.
排除标准
- •Having organic brain lesions (e.g., cerebral hemorrhage, massive cerebral infarction, encephalitis, epilepsy); cardiac QTc interval > 450ms;
- •Current or previous diagnosis of other major diseases (e.g., coronary heart disease, pulmonary heart disease, etc.)
- •Currently or previously diagnosed with a mental disorder other than anxiety disorder (except for insomnia disorder);
- •Those who are participating or have participated in vagus nerve stimulation therapy; those who are participating in transcranial magnetic stimulation or transcranial direct current therapy;
- •Pregnant, breastfeeding, or planning to become pregnant during the trial;
- •Refusing to sign the informed consent form.
结局指标
主要结局
Changes in the Hamilton Anxiety Scale at Baseline and Week 2 of Treatment
时间窗: Baseline and Week 2 of the treatment
The Hamilton Anxiety Scale is a physician evaluation scale commonly used in clinical practice to assess the level of anxiety in patients. Changes in its scores accurately reflect changes in anxiety symptoms. In this study, changes in scores at baseline and the second week of treatment will be used as the primary outcome measure.
次要结局
- Changes in the Generalized Anxiety Scale at Baseline and Week 4 of Treatment(Baseline and Week 4 of the treatment)
- Changes in the Hamilton Depression Scale at Baseline and Week 2 of Treatment(Baseline and Week 2 of the treatment)
- Changes in the Hamilton Depression Scale at Baseline and Week 4 of Treatment(Baseline and Week 4 of the treatment)
- Changes in brain function indicators from baseline to end of treatment(Baseline and Week 4 of the treatment)
- Changes in the Hamilton Anxiety Scale at Baseline and Week 4 of Treatment(Baseline and Week 4 of the treatment)
- Changes in the Generalized Anxiety Scale at Baseline and Week 2 of Treatment(Baseline and Week 2 of the treatment)
- Incidence of adverse events in each group(Baseline and Week 4 of the treatment)