Transcutaneous Vagus Nerve Stimulation for Generalized Anxiety Disorder

Last updated: December 13, 2023
Sponsor: Xijing Hospital
Overall Status: Active - Recruiting

Phase

N/A

Condition

Anxiety Disorders

Mood Disorders

Panic Disorders

Treatment

medication-combined sham stimulation

medication-combined transcutaneous vagus nerve stimulation

Clinical Study ID

NCT06134323
KY20232271-F-1
  • Ages 18-65
  • All Genders

Study 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

Inclusion Criteria:

  • Meeting DSM-5 diagnostic criteria for Generalized Anxiety Disorder;
  • Having a first episode of Generalized Anxiety Disorder or not having used ananxiolytic, antidepressant, antipsychotic, or anticonvulsant medication in the last 1month.
  • Having a Hamilton Anxiety Scale (HAMA) score of more than 14 and a Hamilton DepressionScale (HAMD-17) score of less than 17.

Exclusion

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 transcranialdirect current therapy;
  • Pregnant, breastfeeding, or planning to become pregnant during the trial;
  • Refusing to sign the informed consent form.

Study Design

Total Participants: 82
Treatment Group(s): 2
Primary Treatment: medication-combined sham stimulation
Phase:
Study Start date:
December 05, 2023
Estimated Completion Date:
September 30, 2025

Connect with a study center

  • The First Affiliated Hospital of Air Force Military Medical University

    Xi'an, Shaanxi
    China

    Active - Recruiting

  • Xi'an No.3 Hospital

    Xi'an, Shaanxi
    China

    Active - Recruiting

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