Clinical trial NCT06134323: Transcutaneous Vagus Nerve Stimulation for Generalized Anxiety Disorder
Official title: Efficacy and Mechanism of Transcutaneous Vagus Nerve Stimulation in the Treatment of Generalized Anxiety Disorder
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Generalized Anxiety Disorder
Lead sponsor: Xijing Hospital
Sponsor class: OTHER
First posted: 2023-11-18
Enrollment: 82
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: medication-combined transcutaneous vagus nerve stimulation group or the medication-combined sham stimulation group
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Changes in the Hamilton Anxiety Scale at Baseline and Week 2 of Treatment
timeFrame: Baseline and Week 2 of the treatment
Secondary outcomes:
measure: Changes in the Hamilton Anxiety Scale at Baseline and Week 4 of Treatment
timeFrame: Baseline and Week 4 of the treatment
measure: Changes in the Hamilton Depression Scale at Baseline and Week 2 of Treatment
timeFrame: Baseline and Week 2 of the treatment
measure: Changes in the Hamilton Depression Scale at Baseline and Week 4 of Treatment
timeFrame: Baseline and Week 4 of the treatment
measure: Changes in the Generalized Anxiety Scale at Baseline and Week 2 of Treatment
timeFrame: Baseline and Week 2 of the treatment
measure: Changes in the Generalized Anxiety Scale at Baseline and Week 4 of Treatment
timeFrame: Baseline and Week 4 of the treatment
measure: Changes in brain function indicators from baseline to end of treatment
timeFrame: Baseline and Week 4 of the treatment
measure: Incidence of adverse events in each group
timeFrame: Baseline and Week 4 of the treatment
Other outcomes:
Locations:
city: Xi'an
country: China
facility: The First Affiliated Hospital of Air Force Military Medical University
state: Shaanxi
city: Xi'an
country: China
facility: Xi'an No.3 Hospital
state: Shaanxi
Study officials:
affiliation: The First Affiliated Hospital of the Air Force Medical University
name: Yihuan Yihuan
role: PRINCIPAL_INVESTIGATOR
References:
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citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.