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Acupuncture and Escitalopram for Treating Major Depression Clinical Study (AE-TMDCS)

Primary Purpose

Depressive Disorder, Major

Status
Not yet recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
acupuncture
escitalopram
sham-acupuncure
escitalopram placebo
Sponsored by
Shanghai 7th People's Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Depressive Disorder, Major

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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 Ability to read and understand Mandarin Chinese, at least nine years of education, and willingness to adhere to the study protocol. The absence of acupuncture treatment within at least 1 year. Willingness to participate in the trial and provide written informed consent for the clinical trial. Exclusion Criteria: Lifetime or current neuropsychiatric conditions, such as bipolar disorder, schizophrenia, substance dependence or abuse, dementia, brain injury, epilepsy and so forth. 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. Medicated with antidepressant at the start of the trial or history of treatment failure to escitalopram. Pregnancy or breastfeeding. Subjects who have acute inflammation at the planned acupuncture site on the body or any other contraindication to acupuncture. Candidates afraid of needles in general and reluctant to receive acupuncture in particular 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.

Sites / Locations

  • Jianhua Chen
  • Zhenxiang Han
  • Zouqing Huang

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Sham Comparator

Active Comparator

Active Comparator

Experimental

Arm Label

sham-acupuncture/placebo-pill

sham-acupuncture/escitalopram

active acupuncture/placebo-pill

active acupuncture/escitalopram

Arm Description

sham-acupuncture protocol plus escitalopram placebo

sham-acupuncture protocol plus escitalopram

acupuncture protocol plus escitalopram placebo

acupuncture protocol plus escitalopram

Outcomes

Primary Outcome Measures

HDRS-17 score
the change in the HDRS-17 score

Secondary Outcome Measures

Beck depression inventory score
the change in the Beck depression inventory score
The CGI(Clinical Global Impression)
the change in the CGI
The GAD-7(General Anxiety Disorder)
the change in the GAD-7
The Mini-Mental State Examination (MMSE)
the change in the MMSE

Full Information

First Posted
June 5, 2023
Last Updated
June 5, 2023
Sponsor
Shanghai 7th People's Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05901571
Brief Title
Acupuncture and Escitalopram for Treating Major Depression Clinical Study
Acronym
AE-TMDCS
Official Title
Acupuncture and Escitalopram for Treating Major Depression Clinical Study (AE-TMDCS): Study Design of a Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
September 2023 (Anticipated)
Primary Completion Date
September 2026 (Anticipated)
Study Completion Date
February 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Shanghai 7th People's Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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.
Detailed Description
This is a multicenter, randomized, controlled, 2 by 2 factorial clinical trial for Major depression.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depressive Disorder, Major

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
216 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
sham-acupuncture/placebo-pill
Arm Type
Sham Comparator
Arm Description
sham-acupuncture protocol plus escitalopram placebo
Arm Title
sham-acupuncture/escitalopram
Arm Type
Active Comparator
Arm Description
sham-acupuncture protocol plus escitalopram
Arm Title
active acupuncture/placebo-pill
Arm Type
Active Comparator
Arm Description
acupuncture protocol plus escitalopram placebo
Arm Title
active acupuncture/escitalopram
Arm Type
Experimental
Arm Description
acupuncture protocol plus escitalopram
Intervention Type
Other
Intervention Name(s)
acupuncture
Other Intervention Name(s)
active acupuncture
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
escitalopram
Intervention Description
Patients will receive 10 mg/day of escitalopram for the first 3 weeks and 20mg/day for the remaining 7 weeks.
Intervention Type
Other
Intervention Name(s)
sham-acupuncure
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
escitalopram placebo
Intervention Description
Patients will receive 10 mg/day of escitalopram placebo for the first 3 weeks and 20mg/day for the remaining 7 weeks.
Primary Outcome Measure Information:
Title
HDRS-17 score
Description
the change in the HDRS-17 score
Time Frame
from baseline to 10 weeks
Secondary Outcome Measure Information:
Title
Beck depression inventory score
Description
the change in the Beck depression inventory score
Time Frame
from baseline to 10 weeks
Title
The CGI(Clinical Global Impression)
Description
the change in the CGI
Time Frame
from baseline to 10 weeks
Title
The GAD-7(General Anxiety Disorder)
Description
the change in the GAD-7
Time Frame
from baseline to 10 weeks
Title
The Mini-Mental State Examination (MMSE)
Description
the change in the MMSE
Time Frame
from baseline to 10 weeks
Other Pre-specified Outcome Measures:
Title
BDNF
Description
serum BDNF level
Time Frame
at baseline and 10 week
Title
IL18/IL-1β
Description
serum IL18/IL-1β level
Time Frame
at baseline and 10 week
Title
fMRI
Description
functional MRI
Time Frame
at baseline and 10 week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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 Ability to read and understand Mandarin Chinese, at least nine years of education, and willingness to adhere to the study protocol. The absence of acupuncture treatment within at least 1 year. Willingness to participate in the trial and provide written informed consent for the clinical trial. Exclusion Criteria: Lifetime or current neuropsychiatric conditions, such as bipolar disorder, schizophrenia, substance dependence or abuse, dementia, brain injury, epilepsy and so forth. 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. Medicated with antidepressant at the start of the trial or history of treatment failure to escitalopram. Pregnancy or breastfeeding. Subjects who have acute inflammation at the planned acupuncture site on the body or any other contraindication to acupuncture. Candidates afraid of needles in general and reluctant to receive acupuncture in particular 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Zhenxiang Han, Dr.
Phone
+8617701767768
Email
hanxiang798007@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zhenxiang Han, Dr
Organizational Affiliation
Shanghai Seventh People's Hospital, Shanghai University of TCM
Official's Role
Principal Investigator
Facility Information:
Facility Name
Jianhua Chen
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200030
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jianhua Chen, Dr
Phone
+86 216487250
Facility Name
Zhenxiang Han
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200137
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zhenxiang Han
Phone
8572779808
Email
hanxiang798007@163.com
Facility Name
Zouqing Huang
City
Shanghai
State/Province
Shanghai
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zouqing Huang, Dr
Phone
+86 21 58909293

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
The paper will be published.
IPD Sharing Access Criteria
ResMan IPD
IPD Sharing URL
http://www.medresman.org.cn

Learn more about this trial

Acupuncture and Escitalopram for Treating Major Depression Clinical Study

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