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NCT07392645
Electroacupuncture for Generalized Anxiety Disorder: Clinical Efficacy and Neuroimaging Mechanisms
Conditions: Generalized Anxiety Disorder
Sex: All
Ages: 18 Years – 60 Years
Healthy volunteers: Yes
Phase: NA
Enrollment: 123
Sponsor: Lishu Gao
Location: Affiliated Hangzhou First People's Hospital Hangzhou Zhejiang
Summary
This study aims to evaluate the clinical efficacy and safety of electroacupuncture (EA) as an adjunctive treatment for generalized anxiety disorder (GAD). Participants in the clinical trial will be randomly assigned to an EA group, a sham EA group, or a waiting-list control group. All participants in the clinical trial will receive monotherapy with one of three SSRIs: sertraline, paroxetine, or escitalopram, selected by a psychiatrist according to clinical suitability, previous treatment response, and tolerability. Clinical efficacy will be assessed using the Hamilton Anxiety Rating Scale (HAMA). The neuroimaging substudy will include healthy controls and two groups of patients with GAD receiving SSRI monotherapy with an unchanged medication type and daily dose for at least 2 weeks: an EA group and a sham EA group. Healthy controls will undergo a single resting-state functional MRI (rs-fMRI) scan, whereas patients will undergo scans before and after a single 30-minute EA or sham EA session on the same day. Functional connectivity (FC), regional homogeneity (ReHo), and amplitude of low-frequency fluctuation (ALFF) will be compared between healthy controls and patients before intervention, and pre-to-post changes will be compared between the EA and sham EA groups.
Eligibility Criteria
Inclusion Criteria:
* Meet the DSM-5 diagnostic criteria for Generalized Anxiety Disorder (GAD).
* the patient has been taking the same anxiolytic medication consistently for 2 weeks prior to enrollment.
* HAMA score ≥ 14.
* Right-handed(for MRI).
* Aged 18-60 years, with at least primary school education.
* Signed informed consent.
Exclusion Criteria:
* Complicated with severe cardiovascular, cerebrovascular, or organic diseases.
* History of other psychiatric disorders (e.g., schizophrenia, bipolar disorder).
* Contraindications for MRI (e.g., metal implants, claustrophobia).
* Pregnancy or lactation.
Source: ClinicalTrials.gov (NCT07392645). StuddyBuddy aggregates publicly available trial information.