Recruiting

Comparing Acupuncture With Medication to Reduce Depression, Anxiety and Comorbid Sleep Disorders in China

The main objective of this study is to compare medication (usual care; active comparator) with acupuncture (as experimental intervention) to identify the most (cost)effective and environmentally sustainable intervention to reduce depression, anxiety and comorbid sleep disorders in adults (18-65) in China.

ClinicalTrials.gov IDNCT07552246

PhasePHASE4

Enrollment180

SponsorDuke Kunshan University

Age18 Years

SexALL

I'm interested View official listing

Conditions studied

Anxiety Depression, Sleep

About this study

Interventions

Drug: Psychotropic Drugs — 1. Trazodone (25-150 mg; once daily, 30 minutes before bedtime) or mirtazapine (3.75-30 mg; once daily, 30 minutes before bedtime) 2. Zopiclone (5-10 mg; once daily, taken at bedtime) or lorazepam (0.25-1 mg, once daily, taken at bedtime) Patients may also be prescribed 3. Escitalopram oxalate tablets (10-20 mg; once daily, 30 minutes after breakfast) in cases where Insomnia is Caused by Depressive and Anxious Symptoms The treatment is planned for 4 weeks. After 2 weeks, patients are invited for a check-in visit but there will be no change in the treatment prescribed for 4 weeks
Other: Acupuncture — Manual acupuncture (no sham) will be compared to medication. Acupuncture Points Selected: Bilateral Baihui (GV20), Yintang (GV29), Anmian (EX-HN22), Shenmen (HT7), Neiguan (PC6), Sanyinjiao (SP6), Zhaohai (KI6), Shenmai (BL62), and Taichong (LR3) (29, 30) Operational Procedure: 1. Patient Position: Supine position. 2. Needles: Single-use sterile needles (Specifications: 0.25 mm × 40 mm; Brand: Wuxi Jiajian). 3. Disinfection: Strict disinfection protocols must be performed prior to needling. 4. Needling Technique: After insertion, lifting-thrusting and twirling-rotating manipulation techniques are applied to elicit De Qi (the arrival of Qi). 5. Needle Retention Time: 20 minutes. 6. Treatment Regimen: * Frequency: 3 sessions per week (Monday, Wednesday, and Friday). * Course of Treatment: 9 to 10 sessions per course.

Primary outcomes

Between-groups and within-subjects mean change in depression (Collected at baseline (T0) compared to post-treatment (T1), 3-months follow-up (T2) and 6-months follow-up (T3).)
Between-groups and within-subjects mean change in anxiety (Collected at baseline (T0) compared to post-treatment (T1), 3-months follow-up (T2) and 6-months follow-up (T3).)
Between-groups and within-subjects mean change in sleep condition (Collected at baseline (T0) compared to post-treatment (T1), 3-months follow-up (T2) and 6-months follow-up (T3).)

Eligibility information

Inclusion Criteria: 1. Chinese nationals 18-65 years old 2. At least one of the screening scores below suggestive of depression/anxiety tendencies: 1. Depressive state: Depression Self-Rating Scale (SDS) raw score ≥43; standard score ≥53 (27) 2. Anxiety state: Anxiety Self-Rating Scale (SAS) raw score ≥40; standard score ≥50 (28) Note: (standard score = raw score X 1.25) Exclusion Criteria: 1. Patients with severe comorbid physical illnesses that prevent them from completing the full course of treatment; 2. Patients with a risk of suicide; 3. Patients with a history of head trauma, loss of consciousness, or severe mental disorders; 4. Patients with drugs or alcohol abuse; 5. Patients who have received physical treatment methods within the past 3 months; 6. Patients who have received antidepressant or antipsychotic medication treatment within the past 3 months; 7. Patients with severe skin lesions or skin diseases.

Study locations

Kunshan Mental Health Center and Kunshan Hospital of Traditional Chinese Medicine, Kunshan, Jiangsu China

Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.

Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-09-27.