Electroacupuncture for Generalized Anxiety Disorder: Clinical Efficacy and Neuroimaging Mechanisms
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Electroacupuncture (EA), Sham Electroacupuncture (SEA), Routine Medication.
- Who it may be relevant to
- Registry conditions: Generalized Anxiety Disorder. Basic parameters: 18 years — 60 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Clinical Efficacy of Electroacupuncture for Generalized Anxiety Disorder and Its Central Mechanism Based on Neuroimaging Changes
Overview
This study aims to evaluate the clinical efficacy and safety of electroacupuncture (EA) in treating Generalized Anxiety Disorder (GAD). Participants will be randomly assigned to an EA group, a sham EA group, or a waiting-list control group. All participants will continue their routine medication (Paroxetine). The primary goal is to observe the reduction in anxiety symptoms using the Hamilton Anxiety Scale (HAMA). Additionally, the study will use functional MRI (fMRI) and Magnetic Resonance Spectroscopy (MRS) to explore the brain mechanisms through which EA helps alleviate anxiety.
Interventions
- Procedure Electroacupuncture (EA)
Electroacupuncture (EA) is performed at acupoints including GV20 (Baihui), EX-HN1 (Sishencong), GV29 (Shenting), EX-HN16 (Anmian, bilateral), HT7 (Shenmen, bilateral), PC6 (Neiguan, bilateral), CV6 (Qihai), CV4 (Guanyuan), ST36 (Zusanli, bilateral), SP6 (Sanyinjiao, bilateral), and LR3 (Taichong, bilateral). Sterile disposable needles (φ0.18×25mm or φ0.25×40mm) are used. Electric stimulation (continuous wave, 100Hz) is applied to specific point pairs (e.g., left Sishencong + anterior Sishencong) - Procedure Sham Electroacupuncture (SEA)
Sham electroacupuncture (SEA) is performed by inserting needles into non-acupoints located 5-10 mm away from the real points used in the EA group. Shallow needling (depth of 1-2 mm) is applied. A sham EA device with a disconnected electrode lead is used; although the screen displays parameters identical to the EA group, there is no actual current output. The duration, frequency, and total number of sessions are identical to the EA group (3 times/week for 4 weeks). - Drug Routine Medication
All groups receive Paroxetine Hydrochloride Tablets (20 mg/tablet). The initial dose is 20 mg once daily, taken orally. The daily dose may be increased in increments of 10 mg based on the patient's condition, with a minimum interval of 1 week between adjustments. The maximum daily dose is 50 mg.
Primary outcome measures
- Effective rate of HAMA score reduction at Week 4 [Time frame: Week 4 (at the end of treatment)]
Secondary outcome measures (6)
- Change from Baseline in Hamilton Anxiety Scale (HAMA) Scores [Time frame: Baseline, Week 2, Week 4, and Week 8]
- Change from Baseline in Social Disability Screening Schedule (SDSS) Scores [Time frame: Baseline, Week 2, Week 4, and Week 8]
- Frequency of Participants with Changes in Paroxetine Dosage [Time frame: Week 2, Week 4, and Week 8]
- Treatment Emergent Symptom Scale (TESS) Scores [Time frame: Week 2, Week 4, and Week 8]
- Changes in Functional Connectivity (FC), Regional Homogeneity (ReHo), and Amplitude of Low-Frequency Fluctuation (ALFF) [Time frame: Baseline and Week 4]
- Changes in Brain Metabolite Concentrations via Magnetic Resonance Spectroscopy (MRS) [Time frame: Baseline and Week 4]
Eligibility criteria
Inclusion criteria
- Meet the DSM-5 diagnostic criteria for Generalized Anxiety Disorder (GAD).
- No antidepressant or anti-anxiety medication in the past 2 weeks.
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Triple blind
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07392645 · 2025KY391-1