Major Depressive DisorderNCT05144880
Effects of Electroacupuncture With Different Frequencies for Major Depressive Disorder
A study testing electroacupuncture in people with Major Depressive Disorder, run by Zhejiang Chinese Medical University at 1 site in China.
Trial summary
Two groups of subjects will be included 55 subjects in electroacupuncture with 2Hz group, 55 subjects in the electroacupuncture with 100Hz group. The clinical efficacy of electroacupuncture with different frequencies (2 Hz, 100 Hz) in the treatment of MDD will be observed by evaluation indicators, such as Self-rating… Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Major Depressive Disorder
- What is being tested?
- electroacupuncture
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 1 siteChina
- Study dates
- 1 Nov 2021to 30 Dec 2024
- 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
- Patients suffering from MDD in accordance with the diagnostic criteria;
- Hamilton Depression Scale score is between 21 and 35 (mild to moderate MDD);
- 18≤age≤60 years, both gender;
- Patients who have not used antidepressants and other psychiatric drugs (including traditional Chinese medicine), or have used them but have stopped for at least 2 weeks;
- Patients have clear consciousness and could communicate with others normally;
- Patients could understand the full study protocol and written informed consent is provided by themselves. Note: Subjects who meet the above six items will be included.
Who cannot join
- Patients with bipolar disorder;
- Patients with schizophrenia or other mental disorders;
- Patients with severe medical diseases, tumors or diseases of the central nervous system;
- Patients suffering from severe depressive episode with psychotic symptoms;
- Suicidal patients;
- Patients with seasonal depression;
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- Patients with organic depression;
- Patients with alcohol or drug addicts;
- Patients using other therapies;
- Patients in pregnancy or lactation;
- Patients suffering from cognitive dysfunction, aphasia or other diseases that cannot cooperate with treatment;
- Patients with pacemakers;
- Patients who are not suitable for electroacupuncture.
Trial locations and contacts
1 site in 1 country.
About this study
Two groups of subjects will be included 55 subjects in electroacupuncture with 2Hz group, 55 subjects in the electroacupuncture with 100Hz group. The clinical efficacy of electroacupuncture with different frequencies (2 Hz, 100 Hz) in the treatment of MDD will be observed by evaluation indicators, such as Self-rating depression scale and Hamilton depression scale.
- Conditions
- Major Depressive Disorder
- Being tested
- electroacupuncture
- Medical subject headings
- Depressive Disorder, Major
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
electroacupunctureOther
A total of 12 treatment sessions will be administered to each participant. The acupoints of needles inserted for each participant in each session are DU20, EX-HN1, DU29, HT17, PC6, RN6, RN4, LR3 and SP6. The needles will be manually stimulated by rotating, thrusting, stirring, etc. to produce ''De Qi'' sensation. Then we will use electroacupuncture for acupoint stimulation lasting 30min. The frequency will be set as 2Hz for the electroacupuncture with 2Hz group and the frequency will be set as 100Hz for the electroacupuncture with 100Hz group.
| Study group | Role | What they receive |
|---|---|---|
| electroacupuncture with 2Hz group | Experimental | Not described Receives: Other: electroacupuncture |
| electroacupuncture with 100Hz group | Experimental | Not described Receives: Other: electroacupuncture |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in anxiety and depression severity measure by Self-rating depression scale（SDS）
This scale contains 20 items that reflect the subjective feelings of depression, 10 of which are positive scores and 10 are reverse scores. Each item is divided into four grades according to the frequency of symptoms, If it is a positive scoring question, it will be rated as 1, 2, 3, and 4 points; for a reverse scoring question, it will be rated as 4, 3, 2, and 1. After the evaluation, add up the scores in the 20 items to get the total rough score, and then multiply the rough score by 1.25 and take the integer part to get the standard score
Measured: There will be evaluated before intervention, at 2, 4weeks after intervention and at the end of 4-weeks follow-up.
Change in the severity of depression measure by Hamilton depression scale (HAMD)
This scale is performed by two trained raters to perform a HAMD, usually in the form of conversation and observation. After the examination, the two raters will score independently
Measured: There will be evaluated before intervention, at 2, 4weeks after intervention and at the end of 4-weeks follow-up.
Secondary outcomes (2)
Change in sleep quality measured by Insomnia severity index (ISI)
Measured: There will be evaluated before intervention, at 2, 4weeks after intervention and at the end of 4-weeks follow-up.
Change in Traditional Chinese medicine syndrome score
Measured: There will be evaluated before intervention, at 2, 4weeks after intervention and at the end of 4-weeks follow-up.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2021
- Study start1 Nov 2021
- Primary completion30 Dec 2023 (estimated)
- Study completion30 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Major Depressive DisorderStudies 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
- 110 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhejiang Chinese Medical University
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Xiaoyu Li, Zhejiang Chinese Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05144880
- Sponsor's protocol ID
- 2020YKJ08
- Status last verified
- Jan 2023
- First submitted
- 14 Nov 2021
- Last updated
- 31 Jan 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Electroacupuncture With Different Frequencies for Major Depressive Disorder
- ClinicalTrials.gov ID
- NCT05144880
- Acronym / sponsor ID
- 2020YKJ08
- Conditions
- Major Depressive Disorder
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- Zhejiang Chinese Medical UniversityOther government
- Study start
- 1 Nov 2021 (actual)
- Primary completion
- 30 Dec 2023 (estimated)
- Study completion
- 30 Dec 2024 (estimated)
- First posted
- 3 Dec 2021 (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.
Two groups of subjects will be included 55 subjects in electroacupuncture with 2Hz group, 55 subjects in the electroacupuncture with 100Hz group. The clinical efficacy of electroacupuncture with different frequencies (2 Hz, 100 Hz) in the treatment of MDD will be observed by evaluation indicators, such as Self-rating depression scale and Hamilton depression scale.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| electroacupuncture with 2Hz group | Experimental | Other: electroacupuncture |
| electroacupuncture with 100Hz group | Experimental | Other: electroacupuncture |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Patients suffering from MDD in accordance with the diagnostic criteria;
- Hamilton Depression Scale score is between 21 and 35 (mild to moderate MDD);
- 18≤age≤60 years, both gender;
- Patients who have not used antidepressants and other psychiatric drugs (including traditional Chinese medicine), or have used them but have stopped for at least 2 weeks;
- Patients have clear consciousness and could communicate with others normally;
Key exclusion criteria (13 listed)
- Patients with bipolar disorder;
- Patients with schizophrenia or other mental disorders;
- Patients with severe medical diseases, tumors or diseases of the central nervous system;
- Patients suffering from severe depressive episode with psychotic symptoms;
- Suicidal patients;
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 |
|---|---|---|
| electroacupunctureA total of 12 treatment sessions will be administered to each participant. The acupoints of needles inserted for each participant in each session are DU20, EX-HN1, DU29, HT17, PC6, RN6, RN4, LR3 and SP6. The needles will be manually stimulated by rotating, thrusting, stirring, etc. to produce ''De Qi'' sensation. Then we will use electroacupuncture for acupoint stimulation lasting 30min. The frequency will be set as 2Hz for the electroacupuncture with 2Hz group and the frequency will be set as 100Hz for the electroacupuncture with 100Hz group. | Other | electroacupuncture with 100Hz group, electroacupuncture with 2Hz group |
Primary outcome
Change in anxiety and depression severity measure by Self-rating depression scale（SDS）
Time frame: There will be evaluated before intervention, at 2, 4weeks after intervention and at the end of 4-weeks follow-up.
This scale contains 20 items that reflect the subjective feelings of depression, 10 of which are positive scores and 10 are reverse scores. Each item is divided into four grades according to the frequency of symptoms, If it is a positive scoring question, it will be rated as 1, 2, 3, and 4 points; for a reverse scoring question, it will be rated as 4, 3, 2, and 1. After the evaluation, add up the scores in the 20 items to get the total rough score, and then multiply the rough score by 1.25 and take the integer part to get the standard score
Change in the severity of depression measure by Hamilton depression scale (HAMD)
Time frame: There will be evaluated before intervention, at 2, 4weeks after intervention and at the end of 4-weeks follow-up.
This scale is performed by two trained raters to perform a HAMD, usually in the form of conversation and observation. After the examination, the two raters will score independently
2 secondary outcomes
Change in sleep quality measured by Insomnia severity index (ISI)
Time frame: There will be evaluated before intervention, at 2, 4weeks after intervention and at the end of 4-weeks follow-up.
Change in Traditional Chinese medicine syndrome score
Time frame: There will be evaluated before intervention, at 2, 4weeks after intervention and at the end of 4-weeks follow-up.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2023.
- Individual participant dataSharing planned: Yes
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 in people with Major Depressive Disorder, run by Zhejiang Chinese Medical 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 6 inclusion and 13 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 31 Jan 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. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in anxiety and depression severity measure by Self-rating depression scale（SDS） (time frame: There will be evaluated before intervention, at 2, 4weeks after intervention and at the end of 4-weeks follow-up.). The study lists 2 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 31 Jan 2023.