Electroacupuncture for Generalized Anxiety Disorder: Clinical Efficacy and Neuroimaging Mechanisms

February 5, 2026 updated by: Lishu Gao

Clinical Efficacy of Electroacupuncture for Generalized Anxiety Disorder and Its Central Mechanism Based on Neuroimaging Changes

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

123

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Electroacupuncture (EA) Group
Paroxetine Hydrochloride Tablets + Electroacupuncture
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) for 30 minutes. The current intensity is adjusted to the patient's maximum tolerance. Treatment is administered 3 times per week for 4 weeks (12 sessions total).
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.
Sham Comparator: Sham Electroacupuncture (SEA) Group
Paroxetine Hydrochloride Tablets + Sham Electroacupuncture
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.
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).
Active Comparator: Waiting-list (WL) Group
Paroxetine Hydrochloride Tablets + Delayed EA Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Effective rate of HAMA score reduction at Week 4
Time Frame: Week 4 (at the end of treatment)
The percentage of participants who achieved a HAMA score reduction rate of ≥50% from baseline. HAMA scores are evaluated to categorize outcomes as recovered, markedly effective, effective, or ineffective.
Week 4 (at the end of treatment)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from Baseline in Hamilton Anxiety Scale (HAMA) Scores
Time Frame: Baseline, Week 2, Week 4, and Week 8
HAMA is used to assess the severity of anxiety symptoms. It contains 14 items, including somatic and psychic anxiety. Total scores range from 0 to 56, where higher scores indicate more severe anxiety
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
SDSS is used to evaluate the daily functioning of patients. It consists of 10 items, with each item scored from 0 to 2. Higher total scores reflect a higher degree of social disability.
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
The study will record whether the daily dose of Paroxetine increased, remained unchanged, or decreased compared to the baseline.
Week 2, Week 4, and Week 8
Treatment Emergent Symptom Scale (TESS) Scores
Time Frame: Week 2, Week 4, and Week 8
TESS is used to evaluate adverse reactions to psychiatric medications, covering symptom severity, relationship with the drug, and measures taken.
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
Twenty right-handed subjects will be randomly sampled from each group for the neuroimaging mechanism study. Resting-state functional MRI (fMRI) will be used to analyze brain activity changes. FC describes the synchronization between different brain regions; ReHo and ALFF describe the local homogeneity and intensity of brain activity. Resting-state functional MRI (fMRI) will be used to analyze brain activity changes. FC describes the synchronization between different brain regions; ReHo and ALFF describe the local homogeneity and intensity of brain activity.
Baseline and Week 4
Changes in Brain Metabolite Concentrations via Magnetic Resonance Spectroscopy (MRS)
Time Frame: Baseline and Week 4
Twenty right-handed subjects will be randomly sampled from each group for the neuroimaging mechanism study. 3D 1H-MRS will be used to measure the absolute concentrations of neurotransmitters in ROI (amygdala, hypothalamus, etc.), e.g. 5-HT, NE, DA, GABA, and CRF
Baseline and Week 4

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Lishu Gao

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

February 1, 2026

Primary Completion (Estimated)

October 31, 2027

Study Completion (Estimated)

December 31, 2027

Study Registration Dates

First Submitted

January 29, 2026

First Submitted That Met QC Criteria

February 5, 2026

First Posted (Actual)

February 6, 2026

Study Record Updates

Last Update Posted (Actual)

February 6, 2026

Last Update Submitted That Met QC Criteria

February 5, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2025KY391-1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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