Transcutaneous Vagus Nerve Stimulation for Generalized Anxiety Disorder

NCT06134323 | Unknown

• 1 other identifier: KY20232271-F-1
• Study Type: interventional
• Target: 82
• Locations: 1 country
• Sites: 2

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

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (7)

• Changes in the Hamilton 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 the Generalized Anxiety Scale at Baseline and Week 2 of Treatment

  Baseline and Week 2 of the treatment

• Changes in the Generalized Anxiety Scale at Baseline and Week 4 of Treatment

  Baseline and Week 4 of the treatment

Study Arms (2)

medication-combined transcutaneous vagus nerve stimulation

EXPERIMENTAL

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

Device: medication-combined transcutaneous vagus nerve stimulation

medication-combined sham stimulation group

PLACEBO COMPARATOR

Participants will receive anti-anxiety medication and sham stimulation

Device: medication-combined sham stimulation

Interventions

medication-combined transcutaneous vagus nerve stimulation DEVICE

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

medication-combined transcutaneous vagus nerve stimulation

medication-combined sham stimulation DEVICE

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

medication-combined sham stimulation group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Xijing Hospital: lead

Study Sites (2)

The First Affiliated Hospital of Air Force Military Medical University

Xi'an, Shaanxi, China

RECRUITING

Xi'an No.3 Hospital

Xi'an, Shaanxi, China

RECRUITING

Related Publications (6)

• 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.

  PMID: 30792114 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.

  PMID: 30712879 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.

  PMID: 22854029 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.

  PMID: 28903922 BACKGROUND

• 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.

  PMID: 29467611 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.

  PMID: 30287193 RESULT

MeSH Terms

Conditions

Generalized Anxiety Disorder

Condition Hierarchy (Ancestors)

Anxiety Disorders; Mental Disorders

Study Officials

• Yihuan Yihuan

  The First Affiliated Hospital of the Air Force Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yihuan Yihuan

CONTACT

86-18392135076; chenyihuan12345@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: medication-combined transcutaneous vagus nerve stimulation group or the medication-combined sham stimulation group

Study Record Dates

• First Submitted: November 12, 2023
• First Posted: November 18, 2023
• Study Start: December 5, 2023
• Primary Completion: August 30, 2025
• Study Completion: September 30, 2025
• Last Updated: December 20, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (2)