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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| medication-combined transcutaneous vagus nerve stimulation | Experimental | Participants will receive anti-anxiety medication and transcutaneous vagus nerve stimulation |
|
| medication-combined sham stimulation group | Placebo Comparator | Participants will receive anti-anxiety medication and sham stimulation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| medication-combined transcutaneous vagus nerve stimulation | Device | Two electrodes will be applied 2 cm below the left carotid sinus for active stimulation |
|
| Measure | Description | Time Frame |
|---|---|---|
| Changes in the Hamilton Anxiety Scale at Baseline and Week 2 of 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. | Baseline and Week 2 of the treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in the Hamilton Anxiety Scale at Baseline and Week 4 of 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.Higher scores mean that the patient's anxiety is more severe. | Baseline and Week 4 of the treatment |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yihuan Yihuan | Contact | 86-18392135076 | chenyihuan12345@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Yihuan Yihuan | The First Affiliated Hospital of the Air Force Medical University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital of Air Force Military Medical University | Recruiting | Xi'an | Shaanxi | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30792114 | Background | Huang Y, Wang Y, Wang H, Liu Z, Yu X, Yan J, Yu Y, Kou C, Xu X, Lu J, Wang Z, He S, Xu Y, He Y, Li T, Guo W, Tian H, Xu G, Xu X, Ma Y, Wang L, Wang L, Yan Y, Wang B, Xiao S, Zhou L, Li L, Tan L, Zhang T, Ma C, Li Q, Ding H, Geng H, Jia F, Shi J, Wang S, Zhang N, Du X, Du X, Wu Y. Prevalence of mental disorders in China: a cross-sectional epidemiological study. Lancet Psychiatry. 2019 Mar;6(3):211-224. doi: 10.1016/S2215-0366(18)30511-X. Epub 2019 Feb 18. | |
| 30712879 |
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| ID | Term |
|---|---|
| D000098647 | Generalized Anxiety Disorder |
| ID | Term |
|---|---|
| D001008 | Anxiety Disorders |
| D001523 | Mental Disorders |
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medication-combined transcutaneous vagus nerve stimulation group or the medication-combined sham stimulation group
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| medication-combined sham stimulation | Device | Two electrodes will be applied 2 cm below the left carotid sinus for sham stimulation |
|
| Changes in the Hamilton Depression Scale at Baseline and Week 2 of Treatment | The Hamilton Depression Scale is a physician evaluation scale commonly used in clinical practice to assess the level of depression in patients. Changes in its scores accurately reflect changes in depressive symptoms.Higher scores mean that the patient is more severely depressed. | Baseline and Week 2 of the treatment |
| Changes in the Hamilton Depression Scale at Baseline and Week 4 of Treatment | The Hamilton Depression Scale is a physician evaluation scale commonly used in clinical practice to assess the level of depression in patients. Changes in its scores accurately reflect changes in depressive symptoms.Higher scores mean that the patient is more severely depressed. | Baseline and Week 4 of the treatment |
| Changes in the Generalized Anxiety Scale at Baseline and Week 2 of Treatment | The Generalized Anxiety Scale is a self-assessment scale commonly used in clinical practice to evaluate generalized anxiety symptoms. It has only 7 items and is easy to use.Higher scores mean that the patient's anxiety is more severe. | Baseline and Week 2 of the treatment |
| Changes in the Generalized Anxiety Scale at Baseline and Week 4 of Treatment | The Generalized Anxiety Scale is a self-assessment scale commonly used in clinical practice to evaluate generalized anxiety symptoms. It has only 7 items and is easy to use.Higher scores mean that the patient's anxiety is more severe. | Baseline and Week 4 of the treatment |
| Changes in brain function indicators from baseline to end of treatment | Functional near-infrared spectroscopy and event-related potentials will be used in this study to examine brain function in patients.Event-related potential (ERP) is a special brain evoked potential that is generated by intentionally giving a stimulus a special psychological meaning, using multiple or multiple stimuli. Functional near-infrared spectroscopy (fNIRS) can utilize the good scattering of 600-900nm near-infrared light by the main components of blood to obtain changes in oxyhemoglobin and deoxyhemoglobin during brain activity. | Baseline and Week 4 of the treatment |
| Incidence of adverse events in each group | During the study period, any treatment-related adverse events will be recorded and used to evaluate the safety of the intervention.Common side effects include changes in pronunciation, hoarseness, neck pain, cough, vomiting, etc | Baseline and Week 4 of the treatment |
| Xi'an No.3 Hospital | Recruiting | Xi'an | Shaanxi | China |
|
| Background |
| Slee A, Nazareth I, Bondaronek P, Liu Y, Cheng Z, Freemantle N. Pharmacological treatments for generalised anxiety disorder: a systematic review and network meta-analysis. Lancet. 2019 Feb 23;393(10173):768-777. doi: 10.1016/S0140-6736(18)31793-8. Epub 2019 Jan 31. |
| 22854029 | Background | Bereza BG, Machado M, Ravindran AV, Einarson TR. Evidence-based review of clinical outcomes of guideline-recommended pharmacotherapies for generalized anxiety disorder. Can J Psychiatry. 2012 Aug;57(8):470-8. doi: 10.1177/070674371205700805. |
| 28903922 | Background | Batelaan NM, Bosman RC, Muntingh A, Scholten WD, Huijbregts KM, van Balkom AJLM. Risk of relapse after antidepressant discontinuation in anxiety disorders, obsessive-compulsive disorder, and post-traumatic stress disorder: systematic review and meta-analysis of relapse prevention trials. BMJ. 2017 Sep 13;358:j3927. doi: 10.1136/bmj.j3927. |
| 29467611 | Result | Bonaz B, Bazin T, Pellissier S. The Vagus Nerve at the Interface of the Microbiota-Gut-Brain Axis. Front Neurosci. 2018 Feb 7;12:49. doi: 10.3389/fnins.2018.00049. eCollection 2018. |
| 30287193 | Result | Noble LJ, Meruva VB, Hays SA, Rennaker RL, Kilgard MP, McIntyre CK. Vagus nerve stimulation promotes generalization of conditioned fear extinction and reduces anxiety in rats. Brain Stimul. 2019 Jan-Feb;12(1):9-18. doi: 10.1016/j.brs.2018.09.013. Epub 2018 Sep 21. |