Comparing Acupuncture With Medication to Reduce Anxiety and Depression in China

NCT07552246 | Not Yet Recruiting Phase 4 DMC

• 1 other identifier: 2025CN019
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

The main objective of this study is to compare medication (usual care) with acupuncture (as a standalone comparator) to identify the most (cost)effective and environmentally sustainable intervention to reduce anxiety and mild to moderate depression in adults in China.

Conditions

Anxiety Depression

Keywords

Depression; Acupuncture; Antidepressants; anxiety

Outcome Measures

Primary Outcomes (2)

• Between-groups and within-subjects mean change in depression

  Changes in depression will be measured with Patient Health Questionnaire-9 (PHQ-9). The PHQ-9 is a versatile tool for screening, diagnosing, monitoring, and assessing depression severity. The prompt instruction is: Over the last 2 weeks, how often have you been bothered by any of the following problems? Example of items: "Little interest or pleasure in doing things"; "Feeling down, depressed, or hopeless". Scoring options include: 0=not at all, 1=several days, 2=more than half of the days, 3=nearly every day. Lower mean values suggest aggregate reductions in depression.

  Collected at baseline T0, after intervention T1 (after 3-4 weeks intervention), and at 3-month follow-up T2.

• Between-groups and within-subjects mean change in anxiety

  Change in anxiety will be measured with the Generalised Anxiety Disorder Assessment (GAD-7). GAD-7 is a brief measure for symptoms of anxiety, based on the generalised anxiety disorder (GAD) diagnostic criteria described in the Diagnostic and Statistical Manual of Mental Disorders (DSM). The prompt instruction is: Over the last 2 weeks, how often have you been bothered by any of the following problems? Example of items: "Feeling nervous, anxious, or on edge"; "Not being able to stop or control worrying". Scoring options include: 0=not at all, 1=several days, 2=more than half of the days, 3=nearly every day. Lower mean values suggest aggregate reductions in anxiety.

  Collected at baseline T0, after intervention T1 (after 3-4 weeks intervention), and at 3-month follow-up T2.

Secondary Outcomes (2)

• Between-groups Comparative Environmental Footprint

  After treatment is concluded (Time 1) and 3-months follow-up (Time 2)

• Between-groups Comparative Cost-Effectiveness

  After treatment is concluded (Time 1) and at 3-months follow-up (Time 2)

Other Outcomes (4)

• Between-groups and within-subjects mean change in Side Effects

  Collected at baseline T0, after intervention T1 (after 3-4 weeks intervention), and at 3-month follow-up T2.

• Alcohol Use Rate

  Collected at baseline T0, after intervention T1 (after 3-4 weeks intervention), and at 3-month follow-up T2.

• Smoking Rate

  Collected at baseline T0, after intervention T1 (after 3-4 weeks intervention), and at 3-month follow-up T2.

Study Arms (2)

Selective serotonin reuptake inhibitor (SSRI)

EXPERIMENTAL

Toludesvenlafaxine (40-80 mg daily) or imported Sertraline (50-200 mg daily), supplemented with Lorazepam (0.4-0.8 mg) or Alprazolam (0.4-0.8 mg) as needed for sleep support.

Drug: Selective serotonin reuptake inhibitor (SSRI)

Acupuncture

ACTIVE COMPARATOR

Manual acupuncture (not sham)

Other: Acupuncture

Interventions

Selective serotonin reuptake inhibitor (SSRI) DRUG

This pharmacological intervention (selective serotonin reuptake inhibitor (SSRI)) will be compared to acupuncture (for which no drugs will be involved). Treatment options for medication will be determined by the medical team, the usual care recommended for patients diagnosed with anxiety and depression. Treatment is expected to last 1 month per patient. Expected treatment plan: Administer Toludesvenlafaxine (40-80 mg daily) or imported Sertraline (50-200 mg daily), supplemented with Lorazepam (0.4-0.8 mg) or Alprazolam (0.4-0.8 mg) as needed for sleep support.

Selective serotonin reuptake inhibitor (SSRI)

Acupuncture OTHER

Manual acupuncture (no sham) will be compared to medication. Bilateral Baihui (GV20), Yintang (GV29), Shenmen (HT7), Taichong (LR3), Neiguan (PC6), Sanyinjiao (SP6), and Zusanli (ST36). Procedure: 1. Positioning: The patient lies in a supine position. 2. Needles: Disposable sterile acupuncture needles (specification: 0.25 mm × 40 mm, brand: Wuxi Jiajian) are used. 3. Sterilization: Strict disinfection is performed before needle insertion. 4. Needling Technique: After insertion, lifting-thrusting and twisting techniques are applied to achieve deqi\* (needling sensation). 5. Retention Time: Needles are retained for 20 minutes. 6. Treatment Schedule: * Sessions per week: 3 times. * Course duration: 9-10 sessions per treatment course. Detailed Needling Methods for Each Acupoint Acupoint Location Needling Insertion Technique and Depth Baihui (GV20) On the head, 5 cun\* directly above the midpoint of the anterior hairline. Horizontal insertion to a depth of 0.5-0.8 c

Acupuncture

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Chinese nationals 18 years old and above
• No mental health treatment in the past 6 months
• The patient diagnosis should meet one of the following ICD-10 diagnostic codes (or diagnosed as depressive state/anxiety state/anxious depression state):
• Depressive disorder (F30-F39)
• Fear anxiety disorder (F40)
• Other anxiety disorders (F41)
• Adjustment disorder (F43.2)
• Organic/secondary related disorders (F06)
• F1x.4 Depressive disorder caused by psychoactive substances (x is a substance category, e.g., F10.4 alcohol, F11.4 opioids, etc.)
• F1x.0 Anxiety disorder caused by psychoactive substances
• F42.- Obsessive-compulsive disorder (often accompanied by significant anxiety)
• F48.8 Neurasthenia (may be accompanied by symptoms of anxiety and depression)
• When using scale results (any of the following scales can be used, or other measurable scores/results suggestive of depression/anxiety tendencies):
• Depressive state
• Depression Self-Rating Scale (SDS) standard score ≥ 53 points, or suggesting depressive tendencies

You may not qualify if:

• Serious cardiovascular, cerebrovascular, liver, kidney and other serious life-threatening primary diseases
• Poorly controlled diabetes
• There is a risk of suicide
• Those with head trauma, loss of consciousness or severe mental disorders
• Drug, drug or alcohol abusers
• Received modified electrical convulsions (MECT/ECT), repetitive transcranial magnetic stimulation (r-TMS), vagus electrical stimulation (VNS), within half a year.
• Those who have received antidepressant or psychotic drugs within half a year;
• Those with severe skin injuries and skin diseases.
• Self-injury or even suicidal behavior occurs during the research process;
• Other diseases that suddenly become unsuitable for continued participation in the study during the study;
• Other conditions that the supervising physician deems unsuitable for continued participation in the study.

Sponsors & Collaborators

• Duke Kunshan University: lead
• Kunshan Hospital of Traditional Chinese Medicine: collaborator
• Kunshan Mental Health Center: collaborator
• National Natural Science Foundation of China: collaborator

Study Sites (1)

Kunshan Mental Health Center and Kunshan Hospital of Traditional Chinese Medicine

Kunshan, Jiangsu, China

Location

MeSH Terms

Conditions

Depression; Anxiety Disorders

Interventions

Selective Serotonin Reuptake Inhibitors; Acupuncture Therapy

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Mental Disorders

Intervention Hierarchy (Ancestors)

Neurotransmitter Uptake Inhibitors; Membrane Transport Modulators; Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Neurotransmitter Agents; Serotonin Agents; Physiological Effects of Drugs; Complementary Therapies; Therapeutics

Study Officials

• Claudia Nisa

  Duke Kunshan University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Claudia F. Nisa

CONTACT

008618151144079; claudia.nisa@duke.edu

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Ass Prof Behavioral Science

Study Record Dates

• First Submitted: March 30, 2026
• First Posted: April 27, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): March 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: April 27, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)