Generalized Anxiety DisorderNCT07392645
Electroacupuncture for Generalized Anxiety Disorder: Clinical Efficacy and Neuroimaging Mechanisms
A study testing Electroacupuncture (EA) and Medication in people with Generalized Anxiety Disorder, run by Lishu Gao at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Generalized Anxiety Disorder
- What is being tested?
- Electroacupuncture (EA) and Medication
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 123 participants
- Where
- 1 siteChina
- Study dates
- 10 Mar 2026to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Affiliated Hangzhou First People's Hospital
Hangzhou, Zhejiang
Lishu Gao, +86 56007429, rodelo@sina.com
About this study
Official title: 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) 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.
- Conditions
- Generalized Anxiety Disorder
- Being tested
- Electroacupuncture (EA), Sham Electroacupuncture (SEA), Medication
- Keywords
- Electroacupuncture, Generalized Anxiety Disorder, fMRI, Clinical Efficacy
- Medical subject headings
- Generalized Anxiety Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Electroacupuncture (EA)Procedure or surgery
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).
Sham Electroacupuncture (SEA)Procedure or surgery
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).
MedicationDrug
Each participant will receive only one of the following SSRIs: sertraline, paroxetine, or escitalopram. Medication selection will be made by a psychiatrist before randomization. Dosing and dose adjustments will follow the prespecified medication management protocol, with the same rules applied across all three study groups. Any medication changes and their reasons will be recorded.
| Study group | Role | What they receive |
|---|---|---|
| Electroacupuncture (EA) Group | Experimental | Participants will receive electroacupuncture in addition to SSRI monotherapy with sertraline, paroxetine, or escitalopram, selected and managed by a psychiatrist. Receives: Procedure: Electroacupuncture (EA); Drug: Medication |
| Sham Electroacupuncture (SEA) Group | Sham comparator | Participants will receive sham electroacupuncture in addition to SSRI monotherapy with sertraline, paroxetine, or escitalopram, selected and managed by a psychiatrist. Receives: Procedure: Sham Electroacupuncture (SEA); Drug: Medication |
| Waiting-list (WL) Group | Active comparator | Participants will receive SSRI monotherapy with sertraline, paroxetine, or escitalopram, selected and managed by a psychiatrist, and will be offered delayed electroacupuncture according to the study protocol. Receives: Drug: Medication |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Week 4 (at the end of treatment)
Secondary outcomes (4)
Change from Baseline in Hamilton Anxiety Scale (HAMA) Scores
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
Measured: Baseline, Week 2, Week 4, and Week 8
Change from Baseline in Zung Self-Rating Anxiety Scale (SAS) Scores
The SAS is a 20-item self-report scale assessing anxiety symptoms. Each item is scored from 1 to 4, with positively worded items reverse-scored. The total raw score ranges from 20 to 80 and is multiplied by 1.25 to obtain a standardized score ranging from 25 to 100. Higher scores indicate more severe anxiety. Changes from baseline will be assessed at Weeks 2, 4, and 8, with negative changes indicating improvement.
Measured: Baseline, Week 2, Week 4, and Week 8.
Change from Baseline in Social Disability Screening Schedule (SDSS) Scores
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.
Measured: Baseline, Week 2, Week 4, and Week 8
Frequency of Participants with Changes in medication Dosage
The study will record whether the daily dose of medication increased, remained unchanged, or decreased compared to the baseline.
Measured: Week 2, Week 4, and Week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2026
- Study start10 Mar 2026
- Primary completion31 Oct 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Generalized Anxiety DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 123 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Lishu Gao
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Lishu Gao, First People's Hospital of Hangzhou
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07392645
- Sponsor's protocol ID
- 2025KY391-1
- Status last verified
- Mar 2026
- First submitted
- 29 Jan 2026
- Last updated
- 26 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Efficacy of Electroacupuncture for Generalized Anxiety Disorder and Its Central Mechanism Based on Neuroimaging Changes
- ClinicalTrials.gov ID
- NCT07392645
- Acronym / sponsor ID
- 2025KY391-1
- Conditions
- Generalized Anxiety Disorder
- Keywords
- Electroacupuncture, Generalized Anxiety Disorder, fMRI, Clinical Efficacy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 123 participants (estimated)
- Lead sponsor
- Lishu GaoUniversity, hospital or other
- Study start
- 10 Mar 2026 (actual)
- Primary completion
- 31 Oct 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 6 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Electroacupuncture (EA) Group | Experimental | Procedure: Electroacupuncture (EA), Drug: MedicationParticipants will receive electroacupuncture in addition to SSRI monotherapy with sertraline, paroxetine, or escitalopram, selected and managed by a psychiatrist. |
| Sham Electroacupuncture (SEA) Group | Sham comparator | Procedure: Sham Electroacupuncture (SEA), Drug: MedicationParticipants will receive sham electroacupuncture in addition to SSRI monotherapy with sertraline, paroxetine, or escitalopram, selected and managed by a psychiatrist. |
| Waiting-list (WL) Group | Active comparator | Drug: MedicationParticipants will receive SSRI monotherapy with sertraline, paroxetine, or escitalopram, selected and managed by a psychiatrist, and will be offered delayed electroacupuncture according to the study protocol. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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). | Procedure or surgery | Electroacupuncture (EA) Group |
| 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). | Procedure or surgery | Sham Electroacupuncture (SEA) Group |
| MedicationEach participant will receive only one of the following SSRIs: sertraline, paroxetine, or escitalopram. Medication selection will be made by a psychiatrist before randomization. Dosing and dose adjustments will follow the prespecified medication management protocol, with the same rules applied across all three study groups. Any medication changes and their reasons will be recorded. | Drug | Electroacupuncture (EA) Group, Sham Electroacupuncture (SEA) Group, Waiting-list (WL) Group |
Primary outcome
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.
4 secondary outcomes
Change from Baseline in Hamilton Anxiety Scale (HAMA) Scores
Time frame: Baseline, Week 2, Week 4, and Week 8
Change from Baseline in Zung Self-Rating Anxiety Scale (SAS) 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 medication Dosage
Time frame: Week 2, Week 4, and Week 8
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Electroacupuncture (EA) and Medication in people with Generalized Anxiety Disorder, run by Lishu Gao at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 26 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lishu Gao (+86 13858015836, rodelo@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effective rate of HAMA score reduction at Week 4 (time frame: Week 4 (at the end of treatment)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2026.