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
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
ChinaActive - Recruiting
Xi'an No.3 Hospital
Xi'an, Shaanxi
ChinaActive - Recruiting

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