Electroacupuncture for Generalized Anxiety Disorder: Clinical Efficacy and Neuroimaging Mechanisms

NCT07392645 | Not Yet Recruiting DMC

• 1 other identifier: 2025KY391-1
• Study Type: interventional
• Target: 123
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Generalized Anxiety Disorder

Keywords

Electroacupuncture; Generalized Anxiety Disorder; fMRI; Clinical Efficacy

Outcome Measures

Primary Outcomes (1)

• Effective rate of HAMA score reduction at Week 4

  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 Outcomes (6)

• Change from Baseline in Hamilton Anxiety Scale (HAMA) Scores

  Baseline, Week 2, Week 4, and Week 8

• Change from Baseline in Social Disability Screening Schedule (SDSS) Scores

  Baseline, Week 2, Week 4, and Week 8

• Frequency of Participants with Changes in Paroxetine Dosage

  Week 2, Week 4, and Week 8

• Treatment Emergent Symptom Scale (TESS) Scores

  Week 2, Week 4, and Week 8

• Changes in Functional Connectivity (FC), Regional Homogeneity (ReHo), and Amplitude of Low-Frequency Fluctuation (ALFF)

  Baseline and Week 4

Study Arms (3)

Electroacupuncture (EA) Group

EXPERIMENTAL

Paroxetine Hydrochloride Tablets + Electroacupuncture

Procedure: Electroacupuncture (EA); Drug: Routine Medication

Sham Electroacupuncture (SEA) Group

SHAM COMPARATOR

Paroxetine Hydrochloride Tablets + Sham Electroacupuncture

Procedure: Sham Electroacupuncture (SEA); Drug: Routine Medication

Waiting-list (WL) Group

ACTIVE COMPARATOR

Paroxetine Hydrochloride Tablets + Delayed EA Treatment

Drug: Routine Medication

Interventions

Electroacupuncture (EA) PROCEDURE

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).

Electroacupuncture (EA) Group

Sham Electroacupuncture (SEA) PROCEDURE

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).

Sham Electroacupuncture (SEA) Group

Routine Medication DRUG

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.

Electroacupuncture (EA) Group; Sham Electroacupuncture (SEA) Group; Waiting-list (WL) Group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Lishu Gao: lead

MeSH Terms

Conditions

Generalized Anxiety Disorder

Interventions

Electroacupuncture

Condition Hierarchy (Ancestors)

Anxiety Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Combined Modality Therapy; Therapeutics; Acupuncture Therapy; Complementary Therapies; Electric Stimulation Therapy; Physical Therapy Modalities; Rehabilitation; Transcutaneous Electric Nerve Stimulation; Analgesia; Anesthesia and Analgesia; Anesthesia

Central Study Contacts

Lishu Gao

CONTACT

+86 13858015836; rodelo@sina.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Chief Physician

Study Record Dates

• First Submitted: January 29, 2026
• First Posted: February 6, 2026
• Study Start: February 1, 2026
• Primary Completion (Estimated): October 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: February 6, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share