Effect of Electroacupuncture on Treating the First-episode Depression
NCT ID: NCT05818735
Last Updated: 2023-12-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
204 participants
INTERVENTIONAL
2023-12-01
2026-05-01
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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the electroacupuncture group
the electroacupuncture and the placebo drug
electroacupuncture (EA) treatment
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.
Placebo
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.
the drug group
the sham acupuncture and the drug Escitalopram
sham acupuncture (SA) treatment
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 10mg
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.
Interventions
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electroacupuncture (EA) treatment
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) treatment
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 10mg
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.
Placebo
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Participants whose HDRS-17 score is 17-25 (mild-to-moderate depression).
3. Participants who suffer from depression for the first time.
4. Patients who have not taken any previous antidepressants.
5. Patients who are assessed as low risk for suicide.
6. Participants who have not received acupuncture treatment for at least 1 year.
7. Participants who voluntarily agree with the investigation and sign a written informed consent form.
Exclusion Criteria
2. Participants who are in the depressive episode of bipolar disorder, or suffering from dysthymia, reactive depression and depressive syndrome caused by other diseases.
3. Participants who had severe organic brain diseases and other serious physical diseases.
4. Participants with a history of alcohol abuse or drug dependence.
5. Participants who have enrolled in other clinical trial within 1 months.
6. Pregnant or lactating women.
18 Years
60 Years
ALL
No
Sponsors
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Shanghai Mental Health Center
OTHER
Xuhui Central Hospital, Shanghai
OTHER
Shanghai Huangpu District Mental Health Center
UNKNOWN
Shanghai Municipal Hospital of Traditional Chinese Medicine
OTHER
Responsible Party
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Principal Investigators
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Shifen Xu, Doctor
Role: PRINCIPAL_INVESTIGATOR
Shanghai Municipal Hospital of Traditioal Chinese Medicine
Locations
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Shanghai Mental Health Center
Shanghai, , China
Countries
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Central Contacts
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Facility Contacts
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Jianhua Chen, PhD
Role: primary
Other Identifiers
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Shifen Xu
Identifier Type: -
Identifier Source: org_study_id