Generalized Anxiety Disorder
Conditions
Keywords
Electroacupuncture, Generalized Anxiety Disorder, fMRI, Clinical Efficacy
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.
Interventions
PROCEDUREElectroacupuncture (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).
PROCEDURESham 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).
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.
Sponsors
Lishu Gao
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Effective rate of HAMA score reduction at Week 4 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change from Baseline in Hamilton Anxiety Scale (HAMA) Scores | 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 |
| Change from Baseline in Social Disability Screening Schedule (SDSS) Scores | 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. |
| Frequency of Participants with Changes in Paroxetine Dosage | 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. |
| Treatment Emergent Symptom Scale (TESS) Scores | 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. |
| Changes in Functional Connectivity (FC), Regional Homogeneity (ReHo), and Amplitude of Low-Frequency Fluctuation (ALFF) | 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. |
| Changes in Brain Metabolite Concentrations via Magnetic Resonance Spectroscopy (MRS) | 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 |
Contacts
CONTACTLishu Gao
Outcome results
None listed