Acupuncture and Escitalopram for Treating Major Depression Clinical Study

Depressive Disorder, Major Clinical Trial

— AE-TMDCS  

Official title:

Acupuncture and Escitalopram for Treating Major Depression Clinical Study (AE-TMDCS): Study Design of a Randomized Controlled Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05901571
• Other study ID #: PWRl2021-05
• Secondary ID: 21Y1192100021ZR1
• Status: Not yet recruiting
• Phase: N/A
• Start date: September 2023
• Est. completion date: February 2027

Study information

• Verified date: June 2023
• Source: Shanghai 7th People's Hospital
• Contact: Zhenxiang Han, Dr.
• Phone: +8617701767768
• Email: hanxiang798007[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

We will be able to investigate in a sample of patients free of antidepressants whether acupuncture is more effective than placebo.

Description:

This is a multicenter, randomized, controlled, 2 by 2 factorial clinical trial for Major depression.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 216
• Est. completion date: February 2027
• Est. primary completion date: September 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

1. Between 18 and 75 years of age with no gender-based restriction.

2. Fulfilling the diagnostic criteria of DSM-5 for major depressive disorder.

3. A Hamilton Rating Scale for Depression (HDRS-17) score = 17

4. Ability to read and understand Mandarin Chinese, at least nine years of education, and willingness to adhere to the study protocol.

5. The absence of acupuncture treatment within at least 1 year.

6. Willingness to participate in the trial and provide written informed consent for the clinical trial.

Exclusion Criteria:

1. Lifetime or current neuropsychiatric conditions, such as bipolar disorder, schizophrenia, substance dependence or abuse, dementia, brain injury, epilepsy and so forth.

2. 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.

3. Medicated with antidepressant at the start of the trial or history of treatment failure to escitalopram.

4. Pregnancy or breastfeeding.

5. Subjects who have acute inflammation at the planned acupuncture site on the body or any other contraindication to acupuncture.

6. Candidates afraid of needles in general and reluctant to receive acupuncture in particular

7. Known or suspected clinically unstable systemic medical disorder (including cancer, organ failure, or severe diseases of the cardiovascular, severe hepatic or renal insufficiency).

8. Previous participation in other acupuncture trials.

Related Conditions & MeSH terms

• Depressive Disorder
• Depressive Disorder, Major

Intervention

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.
• escitalopram
Patients will receive 10 mg/day of escitalopram for the first 3 weeks and 20mg/day for the remaining 7 weeks.
• 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.
• escitalopram placebo
Patients will receive 10 mg/day of escitalopram placebo for the first 3 weeks and 20mg/day for the remaining 7 weeks.

Locations

Country	Name	City	State
China	Jianhua Chen	Shanghai	Shanghai
China	Zhenxiang Han	Shanghai	Shanghai
China	Zouqing Huang	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai 7th People's Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	BDNF	serum BDNF level	at baseline and 10 week
Other	IL18/IL-1ß	serum IL18/IL-1ß level	at baseline and 10 week
Other	fMRI	functional MRI	at baseline and 10 week
Primary	HDRS-17 score	the change in the HDRS-17 score	from baseline to 10 weeks
Secondary	Beck depression inventory score	the change in the Beck depression inventory score	from baseline to 10 weeks
Secondary	The CGI(Clinical Global Impression)	the change in the CGI	from baseline to 10 weeks
Secondary	The GAD-7(General Anxiety Disorder)	the change in the GAD-7	from baseline to 10 weeks
Secondary	The Mini-Mental State Examination (MMSE)	the change in the MMSE	from baseline to 10 weeks