Transcutaneous Vagus Nerve Stimulation for Generalized Anxiety Disorder

NCT ID: NCT06134323

Last Updated: 2023-12-20

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 82 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-12-05
• Study Completion Date: 2025-09-30

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.

Conditions

Generalized Anxiety Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

medication-combined transcutaneous vagus nerve stimulation

Participants will receive anti-anxiety medication and transcutaneous vagus nerve stimulation

Group Type: EXPERIMENTAL

medication-combined transcutaneous vagus nerve stimulation

Intervention Type: DEVICE

Two electrodes will be applied 2 cm below the left carotid sinus for active stimulation

medication-combined sham stimulation group

Participants will receive anti-anxiety medication and sham stimulation

Group Type: PLACEBO_COMPARATOR

medication-combined sham stimulation

Intervention Type: DEVICE

Two electrodes will be applied 2 cm below the left carotid sinus for sham stimulation

Interventions

medication-combined transcutaneous vagus nerve stimulation

Two electrodes will be applied 2 cm below the left carotid sinus for active stimulation

Intervention Type: DEVICE

medication-combined sham stimulation

Two electrodes will be applied 2 cm below the left carotid sinus for sham stimulation

Intervention Type: DEVICE

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Xijing Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Yihuan Yihuan

Role: PRINCIPAL_INVESTIGATOR

The First Affiliated Hospital of the Air Force Medical University

Locations

The First Affiliated Hospital of Air Force Military Medical University

Xi'an, Shaanxi, China

Site Status: RECRUITING

Xi'an No.3 Hospital

Xi'an, Shaanxi, China

Site Status: RECRUITING

Countries

China

Central Contacts

Yihuan Yihuan

Role: CONTACT

chenyihuan12345@163.com

86-18392135076

Facility Contacts

Yihuan Chen

Role: primary

Ruiguo Zhang

Role: primary

References

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.

Reference Type: BACKGROUND

PMID: 30792114 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 30712879 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 22854029 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 28903922 (View on PubMed)

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.

Reference Type: RESULT

PMID: 29467611 (View on PubMed)

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.

Reference Type: RESULT

PMID: 30287193 (View on PubMed)

Other Identifiers

KY20232271-F-1

Identifier Type: -

Identifier Source: org_study_id