DepressionNCT05818735
Effect of Electroacupuncture on Treating the First-episode Depression
A study testing electroacupuncture (EA) treatment and Escitalopram 10mg in people with Depression, run by Shanghai Municipal Hospital of Traditional Chinese Medicine at 1 site in China.
Trial summary
Depression is a disease that endangers the physical and mental health of all human beings. Only 30-40% of patients with initial episode depression are cured after treatment with antidepressants. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Depression
- What is being tested?
- electroacupuncture (EA) treatment and Escitalopram 10mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 204 participants
- Where
- 1 siteChina
- Study dates
- 1 Dec 2023to 1 May 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- No healthy volunteers
- Adult
Who may be able to join
- Participants who meet the diagnostic criteria of depression according to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition.
- Participants whose HDRS-17 score is 17-25 (mild-to-moderate depression).
- Participants who suffer from depression for the first time.
- Patients who have not taken any previous antidepressants.
- Patients who are assessed as low risk for suicide.
- Participants who have not received acupuncture treatment for at least 1 year.
- Participants who voluntarily agree with the investigation and sign a written informed consent form.
Who cannot join
- Participants with secondary depressive disorders caused by organic diseases, medicine or psychotic disorders.
- Participants who are in the depressive episode of bipolar disorder, or suffering from dysthymia, reactive depression and depressive syndrome caused by other diseases.
- Participants who had severe organic brain diseases and other serious physical diseases.
- Participants with a history of alcohol abuse or drug dependence.
- Participants who have enrolled in other clinical trial within 1 months.
- Pregnant or lactating women.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Shanghai Mental Health Center
Shanghai
Jianhua Chen, PhD
About this study
Official title: Efficacy and Safety of Electroacupuncture on Treating the First Episode of Mild to Moderate Depression
Depression is a disease that endangers the physical and mental health of all human beings. Only 30-40% of patients with initial episode depression are cured after treatment with antidepressants. Acupuncture is a widely recognized therapy to treat depression in clinical practice, and it can effectively relieve the depressive mood and improve related physical symtoms in patients with mild to moderate depression. This randomised controlled trial (RCT) is aimed to investigate the efficacy and safety of electroacupuncture (EA) in the treatment for patients with the first-episode of mild to moderate depression.
Read the detailed description
Patients will be recruited from the outpatient clinics in Shanghai Municipal Hospital and Shanghai Mental Health Center by Wechat and posters. A total of 204 eligible patients will be randomly allocated to two groups by a randomized block design: the electroacupuncture (EA) group (receiving EA treatment and taking the placebo drugs), and the antidepressants group (receiving sham acupuncture and taking the escitalopram ). After a one-week baseline evalauation, participants will enter a 9-month observation period in this trial, with a 3-month intervention period and a 6-month follow-up period. The interventiuon period will last for 12 weeks, with 3 sessions of real or sham acupuncture treatment per week for the first 8 weeks, and 2 sessions per week for the remaining 4 weeks. The escitalopram or the placebo will be given to the patients at a set time once a week during the 12-week intervention period, with daily oral dose of 10mg or up to 20mg as the maximum dose. Excperts in the Shanghai Mental Health Center will help the participants to adjust the drug dosage during the intervention period. The primary outcome is the 17-item Hamilton Rating Depression Sclae (HRDS-17) at week 12. The secondary outcomes include the recovery rate and the remission rate of depression, the Patient Health Questionnaire(PHQ-9) and the Medical Outcomes Study 36-Item Short Form (SF-36). Adverse effects will be assessed by the Treatment Emergent Symptom Scale through the trial. The software SPSS Version 24.0 for Windows will be used to do the data analysis. All statistical analyses will be based on the intention-to-treat (ITT) population of all randomly assigned patients, with a 2-sided significance level of less than 0.05.
- Conditions
- Depression
- Being tested
- electroacupuncture (EA) treatment, sham acupuncture (SA) treatment, Escitalopram 10mg, Placebo
- Keywords
- first-episode depression, electroacupuncture, anti-depressants, sham acupuncture, placebo drugs, randomized controlled trial
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
electroacupuncture (EA) treatmentOther
The regular acupuncture treatment will be applied at the acupoints including Baihui (GV20), Yintang (GV29), Guanyuan (RN4), Qihai (RN6), bilateral ZuSanli (ST36) and bilateral SanYinjiao (SP6). After needle insertion, rotating or lifting-thrusting manipulation will be applied for 'De qi' sensation. Three pairs of electrodes of the electroacupuncture apparatus will be connected to the needles of GV20 and GV29, and bilateral ST36 and SP6 for 25 minutes, delivering a continuous wave with a frequency of 2-8Hz which is based on the tolerance of each patient. The selection of matching acupuncture points will be determined by the acupuncturist according to the patients' different syndrome patterns.
sham acupuncture (SA) treatmentOther
The sham acpunture treatment will be applied at the same acupoints as the EA treatment with the Streitberger placebo needles. When the blunt needle tip of the placebo needles touches the skin, the patient will get a pricking sensation, but there is no real needle inserted into the skin. The electroacupuncture apparatus will be set on the table beside the patients and two pairs of electrodes will be connected to the needles at bilateral ST36 and SP6. Acupuncturists will turn on the apparatus but all indicators will be set to '0'. Participants will be informed when needles are removed after 25 minutes. Acupuncturists will use dry cotton balls to press the skin around the acupoints when withdrawing the needles so that patients can feel the withdrawal of the 'needles'.
Escitalopram 10mgDrug
Also called real drug application
Escitalopram will be used as the antidepressants for relieving patients' depressive mood. The dose of the drug will be the minimum clinical starting dose of 10 mg once daily, taken orally in the morning, for a period of 3 months. During the intervention period, patients will be allowed to increase the drug dose (up to 20 mg) according to their mental status. Patients will record the details of the drug dose, duration of dosing,responses and possible side effects on a drug dairy. Pateints will receive 7 tablets of escitalopram from an independent dispencer at a set time each week. They may receive additional dose of escitalopram once again during the week if necessary and it will be recorded by the dispenser.
PlaceboDrug
Also called placebo drug application
Placebo drugs are tablets of the same color and size as escitalopram tablets, consisting mainly of starch, and will be tested for safety before being used in the trial. The way the medication is dispensed, the details of how the medication is administered, the dosage, and the record of the drug diary are consistent with the application of the real drugs.
| Study group | Role | What they receive |
|---|---|---|
| the electroacupuncture group | Experimental | the electroacupuncture and the placebo drug Receives: Other: electroacupuncture (EA) treatment; Drug: Placebo |
| the drug group | Placebo comparator | the sham acupuncture and the drug Escitalopram Receives: Other: sham acupuncture (SA) treatment; Drug: Escitalopram 10mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
17-item Hamilton Depression Rating Scale (HDRS-17)
The HDRS-17 is an observer-rating questionnaire with 17 items used to assess the symptoms of patients diagnosed as suffering from depressive states. Each item is rated in 3-point or 5-point scales. A higher total score indicates a higher depression level.
Measured: Week 12
Secondary outcomes (7)
Recovery rate of depression
the percentage of patients with an HDRS-17 score ≤8
Measured: Week 12
Remission rate of depression
the percentage of patients' HDRS-17 score between 8 and 12
Measured: Week 12
HDRS-17
The HDRS-17 is an observer-rating questionnaire with 17 items used to assess the symptoms of patients diagnosed as suffering from depressive states. Each item is rated in 3-point or 5-point scales. A higher total score indicates a higher depression level.
Measured: Week 4, week 8, week 16, week 24 and week 36
Patient Health Questionnaire(PHQ-9)
The PHQ-9 is developed according to the American Diagnostic Criteria for Major Depressive Disorder and is recommended by the WHO as an important tool for screening and assessing the depressive status of patients. It consists of 9 items that are easily and effectively used to understand a subject's depression. The higher the total score indicates the more severe depression.
Measured: Week 4, week 8, week 16, week 24 and week 36
The Medical Outcomes Study 36-Item Short Form Health Survey (SF-36)
It is one of the most widely used quality-of-life assessment scales with good reliability and validity. It provides a comprehensive overview of the participants' level of quality of life in eight dimensions: physiological functioning, physical functioning, somatic pain, general health status, energy, social functioning, emotional functioning, and mental health. A combination of item response(s) is then aggregated to calculate a score for each of the eight dimensions. The scores for each dimension range from 0 to 100, with higher scores indicating better health status.
Measured: Week 4, week 8 and week 12
Drug dairy
A drug record booklet will be issued by the study staff to each patients, and the participants will be asked to record the actual dose, frequency, time of taking drug or side effects everyday.
Measured: Up to 12 weeks
Adverse events（AEs）
Adverse events (AEs) in the trial includes any abnormal events and all types of medical events that were clearly or suspected to be related to the real and sham acupuncture treatment or the drug. Patients may occur focal skin infections, subcutaneous hematomas, and dizziness during the acupuncture treatment, or exacerbation of the condition due to excessive treatment stimulation. AEs including sedation, dizziness, sleep disorders, or constipation due to the drug will be recorded as well. Cold, trauma, or other medical events that resulted in hospitalization during the trial will be also included as AEs.
Measured: Up to 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2023
- Study start1 Dec 2023
- Primary completion31 Dec 2025 (estimated)
- Study completion1 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 204 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Municipal Hospital of Traditional Chinese Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Shanghai Mental Health Center, Xuhui Central Hospital, Shanghai, Shanghai Huangpu District Mental Health Center
- Responsible party
- Sponsor
- Investigators
- Shifen Xu, Doctor, Principal investigator, Shanghai Municipal Hospital of Traditioal Chinese Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05818735
- Sponsor's protocol ID
- Shifen Xu
- Status last verified
- Dec 2023
- First submitted
- 15 Mar 2023
- Last updated
- 15 Dec 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Results will be published by the investigators in academic journals. Data obtained through this study will be provided to qualified researchers with academic interest in acupucnture treatment for depression. Data or samples shared will be coded. The IPD can be shared by sending email to the PI Shifen Xu (xu\_teacher2006@126.com) .
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Electroacupuncture on Treating the First Episode of Mild to Moderate Depression
- ClinicalTrials.gov ID
- NCT05818735
- Acronym / sponsor ID
- Shifen Xu
- Conditions
- Depression
- Keywords
- first-episode depression, electroacupuncture, anti-depressants, sham acupuncture, placebo drugs, randomized controlled trial
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 204 participants (estimated)
- Lead sponsor
- Shanghai Municipal Hospital of Traditional Chinese MedicineUniversity, hospital or other
- Collaborators
- Shanghai Mental Health Center, Xuhui Central Hospital, Shanghai, Shanghai Huangpu District Mental Health Center
- Study start
- 1 Dec 2023 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 1 May 2026 (estimated)
- First posted
- 19 Apr 2023 (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.
Depression is a disease that endangers the physical and mental health of all human beings. Only 30-40% of patients with initial episode depression are cured after treatment with antidepressants. Acupuncture is a widely recognized therapy to treat depression in clinical practice, and it can effectively relieve the depressive mood and improve related physical symtoms in patients with mild to moderate depression. This randomised controlled trial (RCT) is aimed to investigate the efficacy and safety of electroacupuncture (EA) in the treatment for patients with the first-episode of mild to moderate depression.
Detailed description
Patients will be recruited from the outpatient clinics in Shanghai Municipal Hospital and Shanghai Mental Health Center by Wechat and posters. A total of 204 eligible patients will be randomly allocated to two groups by a randomized block design: the electroacupuncture (EA) group (receiving EA treatment and taking the placebo drugs), and the antidepressants group (receiving sham acupuncture and taking the escitalopram ). After a one-week baseline evalauation, participants will enter a 9-month observation period in this trial, with a 3-month intervention period and a 6-month follow-up period. The interventiuon period will last for 12 weeks, with 3 sessions of real or sham acupuncture treatment per week for the first 8 weeks, and 2 sessions per week for the remaining 4 weeks. The escitalopram or the placebo will be given to the patients at a set time once a week during the 12-week intervention period, with daily oral dose of 10mg or up to 20mg as the maximum dose. Excperts in the Shanghai Mental Health Center will help the participants to adjust the drug dosage during the intervention period. The primary outcome is the 17-item Hamilton Rating Depression Sclae (HRDS-17) at week 12. The secondary outcomes include the recovery rate and the remission rate of depression, the Patient Health Questionnaire(PHQ-9) and the Medical Outcomes Study 36-Item Short Form (SF-36). Adverse effects will be assessed by the Treatment Emergent Symptom Scale through the trial. The software SPSS Version 24.0 for Windows will be used to do the data analysis. All statistical analyses will be based on the intention-to-treat (ITT) population of all randomly assigned patients, with a 2-sided significance level of less than 0.05.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| the electroacupuncture group | Experimental | Other: electroacupuncture (EA) treatment, Drug: Placebothe electroacupuncture and the placebo drug |
| the drug group | Placebo comparator | Other: sham acupuncture (SA) treatment, Drug: Escitalopram 10mgthe sham acupuncture and the drug Escitalopram |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Participants who meet the diagnostic criteria of depression according to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition.
- Participants whose HDRS-17 score is 17-25 (mild-to-moderate depression).
- Participants who suffer from depression for the first time.
- Patients who have not taken any previous antidepressants.
- Patients who are assessed as low risk for suicide.
Key exclusion criteria (6 listed)
- Participants with secondary depressive disorders caused by organic diseases, medicine or psychotic disorders.
- Participants who are in the depressive episode of bipolar disorder, or suffering from dysthymia, reactive depression and depressive syndrome caused by other diseases.
- Participants who had severe organic brain diseases and other serious physical diseases.
- Participants with a history of alcohol abuse or drug dependence.
- Participants who have enrolled in other clinical trial within 1 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 |
|---|---|---|
| electroacupuncture (EA) treatmentThe regular acupuncture treatment will be applied at the acupoints including Baihui (GV20), Yintang (GV29), Guanyuan (RN4), Qihai (RN6), bilateral ZuSanli (ST36) and bilateral SanYinjiao (SP6). After needle insertion, rotating or lifting-thrusting manipulation will be applied for 'De qi' sensation. Three pairs of electrodes of the electroacupuncture apparatus will be connected to the needles of GV20 and GV29, and bilateral ST36 and SP6 for 25 minutes, delivering a continuous wave with a frequency of 2-8Hz which is based on the tolerance of each patient. The selection of matching acupuncture points will be determined by the acupuncturist according to the patients' different syndrome patterns. | Other | the electroacupuncture group |
| sham acupuncture (SA) treatmentThe sham acpunture treatment will be applied at the same acupoints as the EA treatment with the Streitberger placebo needles. When the blunt needle tip of the placebo needles touches the skin, the patient will get a pricking sensation, but there is no real needle inserted into the skin. The electroacupuncture apparatus will be set on the table beside the patients and two pairs of electrodes will be connected to the needles at bilateral ST36 and SP6. Acupuncturists will turn on the apparatus but all indicators will be set to '0'. Participants will be informed when needles are removed after 25 minutes. Acupuncturists will use dry cotton balls to press the skin around the acupoints when withdrawing the needles so that patients can feel the withdrawal of the 'needles'. | Other | the drug group |
| Escitalopram 10mgAlso: real drug applicationEscitalopram will be used as the antidepressants for relieving patients' depressive mood. The dose of the drug will be the minimum clinical starting dose of 10 mg once daily, taken orally in the morning, for a period of 3 months. During the intervention period, patients will be allowed to increase the drug dose (up to 20 mg) according to their mental status. Patients will record the details of the drug dose, duration of dosing,responses and possible side effects on a drug dairy. Pateints will receive 7 tablets of escitalopram from an independent dispencer at a set time each week. They may receive additional dose of escitalopram once again during the week if necessary and it will be recorded by the dispenser. | Drug | the drug group |
| PlaceboAlso: placebo drug applicationPlacebo drugs are tablets of the same color and size as escitalopram tablets, consisting mainly of starch, and will be tested for safety before being used in the trial. The way the medication is dispensed, the details of how the medication is administered, the dosage, and the record of the drug diary are consistent with the application of the real drugs. | Drug | the electroacupuncture group |
Primary outcome
17-item Hamilton Depression Rating Scale (HDRS-17)
Time frame: Week 12
The HDRS-17 is an observer-rating questionnaire with 17 items used to assess the symptoms of patients diagnosed as suffering from depressive states. Each item is rated in 3-point or 5-point scales. A higher total score indicates a higher depression level.
7 secondary outcomes
Recovery rate of depression
Time frame: Week 12
Remission rate of depression
Time frame: Week 12
HDRS-17
Time frame: Week 4, week 8, week 16, week 24 and week 36
Patient Health Questionnaire(PHQ-9)
Time frame: Week 4, week 8, week 16, week 24 and week 36
The Medical Outcomes Study 36-Item Short Form Health Survey (SF-36)
Time frame: Week 4, week 8 and week 12
Drug dairy
Time frame: Up to 12 weeks
Adverse events（AEs）
Time frame: Up to 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Dec 2023.
- Individual participant dataSharing planned: Yes. Results will be published by the investigators in academic journals. Data obtained through this study will be provided to qualified researchers with academic interest in acupucnture treatment for depression. Data or samples shared will be coded. The IPD can be shared by sending email to the PI Shifen Xu (xu_teacher2006@126.com) .
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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. This study is not recruiting at the moment.
Shifen Xu, Doctor principal investigator
Shanghai Municipal Hospital of Traditioal Chinese Medicine
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) treatment and Escitalopram 10mg in people with Depression, run by Shanghai Municipal Hospital of Traditional Chinese Medicine 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 7 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 15 Dec 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Shifen Xu, Doctor (8613761931393, xu_teacher2006@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
17-item Hamilton Depression Rating Scale (HDRS-17) (time frame: Week 12). 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 15 Dec 2023.