Status:
UNKNOWN
Transcutaneous Vagus Nerve Stimulation for Generalized Anxiety Disorder
Lead Sponsor:
Xijing Hospital
Conditions:
Generalized Anxiety Disorder
Eligibility:
All Genders
18-65 years
Phase:
NA
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 stimulatio...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
December 5 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 30 2025
Estimated Enrollment :
82 Patients enrolled
Trial Details
Trial ID
NCT06134323
Start Date
December 5 2023
End Date
September 30 2025
Last Update
December 20 2023
Active Locations (2)
Enter a location and click search to find clinical trials sorted by distance.
1
The First Affiliated Hospital of Air Force Military Medical University
Xi'an, Shaanxi, China
2
Xi'an No.3 Hospital
Xi'an, Shaanxi, China