Anxiety DepressionPhase 4NCT07552246
Comparing Acupuncture With Medication to Reduce Depression, Anxiety and Comorbid Sleep Disorders in China
A Phase 4 study testing Psychotropic Drugs and Acupuncture in people with Anxiety Depression and Sleep, run by Duke Kunshan University at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Anxiety Depression, Sleep
- What is being tested?
- Psychotropic Drugs and Acupuncture
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 1 siteChina
- Study dates
- 1 Apr 2026to 31 Dec 2027
- Phase
- Phase 4
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Chinese nationals 18-65 years old
- At least one of the screening scores below suggestive of depression/anxiety tendencies:
- Depressive state: Depression Self-Rating Scale (SDS) raw score ≥43; standard score ≥53 (27)
- Anxiety state: Anxiety Self-Rating Scale (SAS) raw score ≥40; standard score ≥50 (28) Note: (standard score = raw score X 1.25)
Who cannot join
- Patients with severe comorbid physical illnesses that prevent them from completing the full course of treatment;
- Patients with a risk of suicide;
- Patients with a history of head trauma, loss of consciousness, or severe mental disorders;
- Patients with drugs or alcohol abuse;
- Patients who have received physical treatment methods within the past 3 months;
- Patients who have received antidepressant or antipsychotic medication treatment within the past 3 months;
- Patients with severe skin lesions or skin diseases.
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
Kunshan Mental Health Center and Kunshan Hospital of Traditional Chinese Medicine
Kunshan, Jiangsu
About this study
Official title: Comparing Acupuncture With Medication to Reduce Depression, Anxiety and Comorbid Sleep Disorders in China: A Preference-based Trial Comparing Clinical Efficacy, Cost-effectiveness and Environmental Footprint
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.
Read the detailed description
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.
In recent years, there has been a growing focus on how to alleviate emotional distress and promote psychological well-being, prompting researchers to find the most effective treatment from a clinical perspective. At the same time, the healthcare system is also facing financial pressures and environmental sustainability challenges, which requires multiple factors to be considered when choosing patient care options. Therefore, this project intends to compare the clinical efficacy, cost-effectiveness, and environmental footprint of acupuncture versus medication in alleviating anxiety and depressive symptoms in Chinese adults (aged 18 years and above). These analyses provide the necessary basis for the development of rigorous evidence-based policy recommendations.
The World Health Organization (WHO) and the "Healthy China 2030" Plan Outline both attach great importance to integrating the traditional Chinese medicine (TCM) system into the overall medical system. As an important part of TCM, acupuncture is included in the WHO Traditional Medicine Strategy and is encouraged to play a more mainstream role in healthcare treatments. However, neither WHO nor Healthy China 2030 have yet to clarify the role of acupuncture in the specific field of mental health.
This lack of rigorous scientific evidence related to mental health, and acupuncture in particularly, co-exists with the broader growing focus on "complementary and alternative medicine" (CAM), which includes acupuncture, other forms of traditional Chinese medicine and other traditional medicine systems worldwide. CAM and Western medicine differ significantly in terms of concepts, methods, and resource use. CAM is often hypothesized to have a low direct environmental impact due to the use of natural ingredients and the emphasis on prevention, but its actual environmental footprint still needs to be rigorously evaluated. If the efficacy is insufficient (which is often also hypothesized to be the case), it may prolong the course of the disease, increase patient suffering, financial burden and environmental footprint. At present, CAM mainly shows validated efficacy in physical health. For example, some studies have shown that acupuncture has certain effects in relieving chronic lower back pain and arthritis pain. Mind-body practices such as meditation and yoga also have a positive impact on cardiovascular health, such as lowering blood pressure and improving respiratory efficiency.
However, in the field of mental health, relevant research is insufficient. The available evidence is often methodologically limited and limited by research bias based on Western samples, making it difficult to fully assess the global applicability of CAM. Although there is preliminary evidence that acupuncture may have positive effects on mental health, there is still a lack of systematic comparative studies, especially direct comparisons with mainstream Western therapies and differences in their environmental effects.
- Conditions
- Anxiety Depression, Sleep
- Being tested
- Psychotropic Drugs, Acupuncture
- Keywords
- Depression, Acupuncture, Antidepressants, anxiety, sleep
- Medical subject headings
- Depression, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Psychotropic DrugsDrug
- Trazodone (25-150 mg; once daily, 30 minutes before bedtime) or mirtazapine (3.75-30 mg; once daily, 30 minutes before bedtime)
- 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
AcupunctureOther
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:
- Patient Position: Supine position.
- Needles: Single-use sterile needles (Specifications: 0.25 mm × 40 mm; Brand: Wuxi Jiajian).
- Disinfection: Strict disinfection protocols must be performed prior to needling.
- Needling Technique: After insertion, lifting-thrusting and twirling-rotating manipulation techniques are applied to elicit De Qi (the arrival of Qi).
- Needle Retention Time: 20 minutes.
- Treatment Regimen:
- Frequency: 3 sessions per week (Monday, Wednesday, and Friday).
- Course of Treatment: 9 to 10 sessions per course.
| Study group | Role | What they receive |
|---|---|---|
| Psychotropic Drugs | Active comparator | 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 Receives: Drug: Psychotropic Drugs |
| Acupuncture | Experimental | Acupuncture Points Selected: Bilateral Baihui (GV20), Yintang (GV29), Anmian (EX-HN22), Shenmen (HT7), Neiguan (PC6), Sanyinjiao (SP6), Zhaohai (KI6), Shenmai (BL62), and Taichong (LR3) Receives: Other: Acupuncture |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
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.
Measured: 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
Changes in sleep will be measured with Sleep Condition Indicator (SCI). The Sleep Condition Indicator (SCI) is an eight-item rating scale that was developed to screen for insomnia disorder based on DSM-5 criteria. It has been shown previously to have good psychometric properties among several language translations. The prompt instruction is: Thinking about a typical night in the last month... Example of items: "How long does it take you to fall asleep?"; "How would you rate your sleep quality?". Scoring options from 0 to 4, SCI total from minimum 0 to maximum 32; a higher score means better sleep.
Measured: Collected at baseline (T0) compared to post-treatment (T1), 3-months follow-up (T2) and 6-months follow-up (T3).
Secondary outcomes (2)
Between-groups Comparative Environmental Footprint
To calculate the comparative environmental impacts of acupuncture versus antidepressants to reduce postpartum depression, we will consider a range of factors including list of resources, quantities used (e.g., electricity, water), emissions factors and indirect emissions e.g., supply chain. We will follow validated calculation methods for healthcare, which will allow to identify, measure and evaluate the total emission impacts of different health treatments. This calculation will document all resources used in both arms of the trial, including medications, acupuncture materials, travel, infrastructure use (e.g., clinic space), and any other resources engaged during the trial. Both treatments have waste that must be managed. We will normalize the footprint data per patient or per unit of clinical improvement to facilitate a direct comparison between the two treatments. The final single, combined value will be reported as CO2 emissions in tonnes.
Measured: After treatment is concluded (Time 1) and 3-months follow-up (Time 2)
Between-groups and within-subjects mean change in Side Effects
Participants will be asked to rate the frequency of possible side effects. The prompt instruction is: How often have you been bothered by these problems in the last 2 weeks? Nausea; Headache; Tremor/ shaking hands; Heart palpitations; Constipation; Dizziness; Indigestion; Pain; Insomnia; Fatigue. Scoring options include: 0=not at all, 1=several days, 2=more than half of the days, 3=nearly every day. Lower values suggest lower rates of side effects.
Measured: Collected at baseline (T0) compared to post-treatment (T1), 3-months follow-up (T2) and 6-months follow-up (T3).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2026
- Study start1 Apr 2026
- Primary completion30 Jun 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 Anxiety DepressionStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- It was observed in preliminary stages of the trial that patients have very strong preferences for either acupuncture or medication. Many patients refused to be randomly assigned to treatment. Thus, the trial was changed to a preference-based trial, which allows for some patients to choose which treatment they prefer (N=60 per group in a total of 120 non-randomized patients), and for patients without a strong preference, these are randomly allocated to different treatments (N=30 per group in a total of 60 randomized patients).
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Duke Kunshan University
- Sponsor type
- University, hospital or other
- Collaborators
- Kunshan Hospital of Traditional Chinese Medicine, Kunshan Mental Health Center, National Natural Science Foundation of China
- Responsible party
- Principal investigator, Claudia Nisa, Duke Kunshan University
- Investigators
- Claudia Nisa, Principal investigator, Duke Kunshan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07552246
- Sponsor's protocol ID
- 2025CN019
- Status last verified
- Jul 2026
- First submitted
- 30 Mar 2026
- Last updated
- 29 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Guidelines from the Chinese Government prevent sharing Chinese nationals individual participant data (IPD) with foreigners
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing Acupuncture With Medication to Reduce Depression, Anxiety and Comorbid Sleep Disorders in China: A Preference-based Trial Comparing Clinical Efficacy, Cost-effectiveness and Environmental Footprint
- ClinicalTrials.gov ID
- NCT07552246
- Acronym / sponsor ID
- 2025CN019
- Conditions
- Anxiety Depression, Sleep
- Keywords
- Depression, Acupuncture, Antidepressants, anxiety, sleep
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Duke Kunshan UniversityUniversity, hospital or other
- Collaborators
- Kunshan Hospital of Traditional Chinese Medicine, Kunshan Mental Health Center, National Natural Science Foundation of China
- Study start
- 1 Apr 2026 (actual)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 27 Apr 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.
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.
Detailed description
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.
In recent years, there has been a growing focus on how to alleviate emotional distress and promote psychological well-being, prompting researchers to find the most effective treatment from a clinical perspective. At the same time, the healthcare system is also facing financial pressures and environmental sustainability challenges, which requires multiple factors to be considered when choosing patient care options. Therefore, this project intends to compare the clinical efficacy, cost-effectiveness, and environmental footprint of acupuncture versus medication in alleviating anxiety and depressive symptoms in Chinese adults (aged 18 years and above). These analyses provide the necessary basis for the development of rigorous evidence-based policy recommendations.
The World Health Organization (WHO) and the "Healthy China 2030" Plan Outline both attach great importance to integrating the traditional Chinese medicine (TCM) system into the overall medical system. As an important part of TCM, acupuncture is included in the WHO Traditional Medicine Strategy and is encouraged to play a more mainstream role in healthcare treatments. However, neither WHO nor Healthy China 2030 have yet to clarify the role of acupuncture in the specific field of mental health.
This lack of rigorous scientific evidence related to mental health, and acupuncture in particularly, co-exists with the broader growing focus on "complementary and alternative medicine" (CAM), which includes acupuncture, other forms of traditional Chinese medicine and other traditional medicine systems worldwide. CAM and Western medicine differ significantly in terms of concepts, methods, and resource use. CAM is often hypothesized to have a low direct environmental impact due to the use of natural ingredients and the emphasis on prevention, but its actual environmental footprint still needs to be rigorously evaluated. If the efficacy is insufficient (which is often also hypothesized to be the case), it may prolong the course of the disease, increase patient suffering, financial burden and environmental footprint. At present, CAM mainly shows validated efficacy in physical health. For example, some studies have shown that acupuncture has certain effects in relieving chronic lower back pain and arthritis pain. Mind-body practices such as meditation and yoga also have a positive impact on cardiovascular health, such as lowering blood pressure and improving respiratory efficiency.
However, in the field of mental health, relevant research is insufficient. The available evidence is often methodologically limited and limited by research bias based on Western samples, making it difficult to fully assess the global applicability of CAM. Although there is preliminary evidence that acupuncture may have positive effects on mental health, there is still a lack of systematic comparative studies, especially direct comparisons with mainstream Western therapies and differences in their environmental effects.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- It was observed in preliminary stages of the trial that patients have very strong preferences for either acupuncture or medication. Many patients refused to be randomly assigned to treatment. Thus, the trial was changed to a preference-based trial, which allows for some patients to choose which treatment they prefer (N=60 per group in a total of 120 non-randomized patients), and for patients without a strong preference, these are randomly allocated to different treatments (N=30 per group in a total of 60 randomized patients).
| Arm | Type | Receives |
|---|---|---|
| Psychotropic Drugs | Active comparator | Drug: Psychotropic Drugs1. 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 |
| Acupuncture | Experimental | Other: AcupunctureAcupuncture Points Selected: Bilateral Baihui (GV20), Yintang (GV29), Anmian (EX-HN22), Shenmen (HT7), Neiguan (PC6), Sanyinjiao (SP6), Zhaohai (KI6), Shenmai (BL62), and Taichong (LR3) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Chinese nationals 18-65 years old
- At least one of the screening scores below suggestive of depression/anxiety tendencies:
Key exclusion criteria (7 listed)
- Patients with severe comorbid physical illnesses that prevent them from completing the full course of treatment;
- Patients with a risk of suicide;
- Patients with a history of head trauma, loss of consciousness, or severe mental disorders;
- Patients with drugs or alcohol abuse;
- Patients who have received physical treatment methods within the past 3 months;
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 |
|---|---|---|
| Psychotropic Drugs1. 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 | Drug | Psychotropic Drugs |
| AcupunctureManual 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. | Other | Acupuncture |
Primary outcome
Between-groups and within-subjects mean change in depression
Time frame: Collected at baseline (T0) compared to post-treatment (T1), 3-months follow-up (T2) and 6-months follow-up (T3).
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.
Between-groups and within-subjects mean change in anxiety
Time frame: Collected at baseline (T0) compared to post-treatment (T1), 3-months follow-up (T2) and 6-months follow-up (T3).
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.
Between-groups and within-subjects mean change in sleep condition
Time frame: Collected at baseline (T0) compared to post-treatment (T1), 3-months follow-up (T2) and 6-months follow-up (T3).
Changes in sleep will be measured with Sleep Condition Indicator (SCI). The Sleep Condition Indicator (SCI) is an eight-item rating scale that was developed to screen for insomnia disorder based on DSM-5 criteria. It has been shown previously to have good psychometric properties among several language translations. The prompt instruction is: Thinking about a typical night in the last month... Example of items: "How long does it take you to fall asleep?"; "How would you rate your sleep quality?". Scoring options from 0 to 4, SCI total from minimum 0 to maximum 32; a higher score means better sleep.
2 secondary outcomes
Between-groups Comparative Environmental Footprint
Time frame: After treatment is concluded (Time 1) and 3-months follow-up (Time 2)
Between-groups and within-subjects mean change in Side Effects
Time frame: Collected at baseline (T0) compared to post-treatment (T1), 3-months follow-up (T2) and 6-months follow-up (T3).
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 29 Jul 2026.
- Individual participant dataSharing planned: No. Guidelines from the Chinese Government prevent sharing Chinese nationals individual participant data (IPD) with foreigners
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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.
Claudia Nisa principal investigator
Duke Kunshan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Psychotropic Drugs and Acupuncture in people with Anxiety Depression and Sleep, run by Duke Kunshan University 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 4 inclusion and 7 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 29 Jul 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Claudia F. Nisa (008618151144079, claudia.nisa@duke.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Between-groups and within-subjects mean change in depression (time frame: Collected at baseline (T0) compared to post-treatment (T1), 3-months follow-up (T2) and 6-months follow-up (T3).). The study lists 3 primary outcomes in all. 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 29 Jul 2026.