AE-TMDCS: Acupuncture and Escitalopram for Treating Major Depression Clinical Study
Study Details
Study Description
Brief Summary
We will be able to investigate in a sample of patients free of antidepressants whether acupuncture is more effective than placebo.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
This is a multicenter, randomized, controlled, 2 by 2 factorial clinical trial for Major depression.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Sham Comparator: sham-acupuncture/placebo-pill sham-acupuncture protocol plus escitalopram placebo |
Other: sham-acupuncure
In the sham acupuncture group, superficial skin penetration (2 to 3 mm in depth) at nonacupoints will be done without De Qi manipulations. Nonacupoints are away from conventional acupoints or meridians. The choice of sham acupuncture points, which are points located in an emplacement different than the meridian points. The sham acupoints are not standard acupoints and will be about 1cun ( ≈20 mm) lateral from the real acupoints in the experimental group.
Other: escitalopram placebo
Patients will receive 10 mg/day of escitalopram placebo for the first 3 weeks and 20mg/day for the remaining 7 weeks.
|
| Active Comparator: sham-acupuncture/escitalopram sham-acupuncture protocol plus escitalopram |
Other: escitalopram
Patients will receive 10 mg/day of escitalopram for the first 3 weeks and 20mg/day for the remaining 7 weeks.
Other: sham-acupuncure
In the sham acupuncture group, superficial skin penetration (2 to 3 mm in depth) at nonacupoints will be done without De Qi manipulations. Nonacupoints are away from conventional acupoints or meridians. The choice of sham acupuncture points, which are points located in an emplacement different than the meridian points. The sham acupoints are not standard acupoints and will be about 1cun ( ≈20 mm) lateral from the real acupoints in the experimental group.
|
| Active Comparator: active acupuncture/placebo-pill acupuncture protocol plus escitalopram placebo |
Other: acupuncture
The acupuncture group will receive treatment with needles inserted at the specified acupoints. Selected by acupuncture experts, these acupoints include SP4 (Gongsun) , PC6 (Neiguan) , PC5 (Jianshi) and LV 3 (Taichong) bilaterally. All acupoints are localized according to the WHO Standard Acupuncture Locations.After needle insertion, the acupuncture needles will be manipulated using either the twirling-rotating or lifting-thrusting methods to achieve the "De Qi" sensation.
Other Names:
Other: escitalopram placebo
Patients will receive 10 mg/day of escitalopram placebo for the first 3 weeks and 20mg/day for the remaining 7 weeks.
|
| Experimental: active acupuncture/escitalopram acupuncture protocol plus escitalopram |
Other: acupuncture
The acupuncture group will receive treatment with needles inserted at the specified acupoints. Selected by acupuncture experts, these acupoints include SP4 (Gongsun) , PC6 (Neiguan) , PC5 (Jianshi) and LV 3 (Taichong) bilaterally. All acupoints are localized according to the WHO Standard Acupuncture Locations.After needle insertion, the acupuncture needles will be manipulated using either the twirling-rotating or lifting-thrusting methods to achieve the "De Qi" sensation.
Other Names:
Other: escitalopram
Patients will receive 10 mg/day of escitalopram for the first 3 weeks and 20mg/day for the remaining 7 weeks.
|
Outcome Measures
Primary Outcome Measures
- HDRS-17 score [from baseline to 10 weeks]
the change in the HDRS-17 score
Secondary Outcome Measures
- Beck depression inventory score [from baseline to 10 weeks]
the change in the Beck depression inventory score
- The CGI(Clinical Global Impression) [from baseline to 10 weeks]
the change in the CGI
- The GAD-7(General Anxiety Disorder) [from baseline to 10 weeks]
the change in the GAD-7
- The Mini-Mental State Examination (MMSE) [from baseline to 10 weeks]
the change in the MMSE
Other Outcome Measures
- BDNF [at baseline and 10 week]
serum BDNF level
- IL18/IL-1β [at baseline and 10 week]
serum IL18/IL-1β level
- fMRI [at baseline and 10 week]
functional MRI
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Between 18 and 75 years of age with no gender-based restriction.
-
Fulfilling the diagnostic criteria of DSM-5 for major depressive disorder.
-
A Hamilton Rating Scale for Depression (HDRS-17) score ≥ 17
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Ability to read and understand Mandarin Chinese, at least nine years of education, and willingness to adhere to the study protocol.
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The absence of acupuncture treatment within at least 1 year.
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Willingness to participate in the trial and provide written informed consent for the clinical trial.
Exclusion Criteria:
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Lifetime or current neuropsychiatric conditions, such as bipolar disorder, schizophrenia, substance dependence or abuse, dementia, brain injury, epilepsy and so forth.
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High suicide risk or presenting with suicidal ideation (a score of more than 2 points on the Suicide question of the HDRS-17) at the time of entry.
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Medicated with antidepressant at the start of the trial or history of treatment failure to escitalopram.
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Pregnancy or breastfeeding.
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Subjects who have acute inflammation at the planned acupuncture site on the body or any other contraindication to acupuncture.
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Candidates afraid of needles in general and reluctant to receive acupuncture in particular
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Known or suspected clinically unstable systemic medical disorder (including cancer, organ failure, or severe diseases of the cardiovascular, severe hepatic or renal insufficiency).
-
Previous participation in other acupuncture trials.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Jianhua Chen | Shanghai | Shanghai | China | 200030 |
| 2 | Zhenxiang Han | Shanghai | Shanghai | China | 200137 |
| 3 | Zouqing Huang | Shanghai | Shanghai | China |
Sponsors and Collaborators
- Shanghai 7th People's Hospital
Investigators
- Principal Investigator: Zhenxiang Han, Dr, Shanghai Seventh People's Hospital, Shanghai University of TCM
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- PWRl2021-05
- 21Y11921000
- 21ZR1449300