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

June 5, 2023 updated by: Shanghai 7th People's Hospital

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

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

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment (Estimated)

216

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 200030
        • Jianhua Chen
        • Contact:
          • Jianhua Chen, Dr
          • Phone Number: +86 216487250
      • Shanghai, Shanghai, China, 200137
      • Shanghai, Shanghai, China
        • Zouqing Huang
        • Contact:
          • Zouqing Huang, Dr
          • Phone Number: +86 21 58909293

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / 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: 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
Patients will receive 10 mg/day of escitalopram for the first 3 weeks and 20mg/day for the remaining 7 weeks.
Active Comparator: active acupuncture/placebo-pill
acupuncture protocol plus escitalopram placebo
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.
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:
  • active acupuncture
Experimental: active acupuncture/escitalopram
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: 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:
  • active acupuncture

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
HDRS-17 score
Time Frame: from baseline to 10 weeks
the change in the HDRS-17 score
from baseline to 10 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Beck depression inventory score
Time Frame: from baseline to 10 weeks
the change in the Beck depression inventory score
from baseline to 10 weeks
The CGI(Clinical Global Impression)
Time Frame: from baseline to 10 weeks
the change in the CGI
from baseline to 10 weeks
The GAD-7(General Anxiety Disorder)
Time Frame: from baseline to 10 weeks
the change in the GAD-7
from baseline to 10 weeks
The Mini-Mental State Examination (MMSE)
Time Frame: from baseline to 10 weeks
the change in the MMSE
from baseline to 10 weeks

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
BDNF
Time Frame: at baseline and 10 week
serum BDNF level
at baseline and 10 week
IL18/IL-1β
Time Frame: at baseline and 10 week
serum IL18/IL-1β level
at baseline and 10 week
fMRI
Time Frame: at baseline and 10 week
functional MRI
at baseline and 10 week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shanghai 7th People's Hospital

Investigators

  • Principal Investigator: Zhenxiang Han, Dr, Shanghai Seventh People's Hospital, Shanghai University of TCM

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

September 1, 2023

Primary Completion (Estimated)

September 1, 2026

Study Completion (Estimated)

February 1, 2027

Study Registration Dates

First Submitted

June 5, 2023

First Submitted That Met QC Criteria

June 5, 2023

First Posted (Estimated)

June 13, 2023

Study Record Updates

Last Update Posted (Estimated)

June 13, 2023

Last Update Submitted That Met QC Criteria

June 5, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PWRl2021-05
  • 21Y11921000 (Other Grant/Funding Number: Shanghai science and techonology committe)
  • 21ZR1449300 (Other Grant/Funding Number: Natural Science Foundation of Shanghai)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

The paper will be published.

IPD Sharing Access Criteria

ResMan IPD

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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