Treating Depression With Transcutaneous Electrical Cranial-auricular Acupoint Stimulation (TECAS). (TECAS)

November 24, 2021 updated by: Prof. Zhang Zhang-Jin, The University of Hong Kong

Effectiveness and Safety of Transcutaneous Electrical Cranial-auricular Acupoint Stimulation (TECAS) for Patients With Mild-to-moderate Depression.

One multi-center, randomized controlled clinical trial is designed to examine whether transcutaneous electrical cranial-auricular acupoint stimulation (TECAS) is non-inferior to the antidepressant drug (Escitalopram) in treating mild-to-moderate depression, to evaluate the depressive subtypes who are suitable for the TECAS treatment. To achieve this objective, 470 patients with mild-to-moderate depression will be recruited and assigned to receive TECAS treatment (n =235) or Escitalopram (n =235, 10-20mg/day, q.d.) for 8 weeks. The primary outcome is the Montgomery-Åsberg Depression Rating Scale (MADRS); other outcomes include the17-item Hamilton Depression Scale (HAMD-17), the Hamilton Anxiety Rating Scale (HAMA), Pittsburgh sleep quality index (PSQI), the Short Form 36 Health Survey and TCM diagnosis of depression. In addition, the safety index will be measured throughout the whole study.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Depression is a common and costly disorder with high prevalence rate and high suicide rate. Antidepressants are the first-line treatments for depression. However, approximately 50% to 60% of the patients have not achieved adequate response following antidepressant treatment.

A large body of evidence well confirms that electro-acupuncture is effective in improving depression and reducing anti-depressant treatment-caused side effects, including pain, nausea, dizziness, fatigue, anxiety and sleep disturbance.

Based on the combination of ancient and modern literature and famous traditional Chinese medicine practitioners' experience, the Evidence-based Guidelines of Clinical Practice with Acupuncture and Moxibustion-Depression (ZJ/TE003-2014) recommended Baihui (DU20) and Yintang (DU29) as main acupoints in treating patients with depression via electro-acupuncture.

Our research team have completed a series of clinical trials, including electrical stimulation on cranial and auricular acupoints for treating depression, postpartum depression, post-stroke depression, and depression with somatic pain. These studies found that cranial-auricular acupoint stimulation, as well as transcutaneous electrical stimulation, can improve depressive symptoms and accompanying symptoms in patients with depression significantly.

Unlike traditional acupuncture, transcutaneous electrical stimulation does not need needles to penetrate the skin. It places electrodes on the skin of the corresponding acupoints. In this way, traumatic pain and fear of acupuncture can be avoided. And it is more easily accepted for patients and more convenient for clinical operation. Therefore, the investigators plan to build a novel transcutaneous electrical stimulation therapy--Transcutaneous electrical cranial-auricular acupoint stimulation (TECAS).

In the proposed study, a combination of transcutaneous electrical cranial and transcutaneous electrical auricular acupoint stimulation will be employed to treat patients with mild-to-moderate depression compared with antidepressant Escitalopram, to confirm the clinical effectiveness of TECAS in mild-to-moderate depression.

Study Type

Interventional

Enrollment (Anticipated)

470

Phase

  • Phase 2
  • Phase 3

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

  • Name: Xin-Jing YANG, PhD
  • Phone Number: +852 1870150 1833
  • Email: yangxj@hku.hk

Study Contact Backup

  • Name: Sui-Cheung MAN, BCM, PhD
  • Phone Number: +852 39176445
  • Email: marksman@hku.hk

Study Locations

  • China
      • Beijing, China, 100026
        • Recruiting
        • Beijing First Hospital of Integrated Chinese and Western Medicine
        • Contact:
        • Contact:
        • Principal Investigator:
          • Xiao-Bin HOU
      • Beijing, China, 100053
        • Recruiting
        • Guang'anmen Hospital of the Chinese Academy of Chinese Medical Science
        • Contact:
        • Contact:
        • Principal Investigator:
          • Feng-Quan XU
    • Guangdong
      • Shenzhen, Guangdong, China, 518053
        • Recruiting
        • Department of Chinese Medicine, The University of Hong Kong-Shenzhen Hospital
        • Contact:
        • Principal Investigator:
          • Shui-Yan ZHANG
      • Shenzhen, Guangdong, China, 518053
        • Recruiting
        • Department of neurology, The University of Hong Kong-Shenzhen Hospital
        • Principal Investigator:
          • Shui-Yan ZHANG
        • Contact:
    • Shijiazhuang
      • Hebei, Shijiazhuang, China, 050051
        • Recruiting
        • The First Hospital Of Hebei Medical University
        • Contact:
        • Contact:
        • Principal Investigator:
          • Gui-Xing JIN
    • Sichuan
      • Luzhou, Sichuan, China, 646000
        • Recruiting
        • Southwest Medical University, Hospital of Traditional Chinese Medicine
        • Contact:
        • Contact:

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

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Primary diagnosis as mild to moderate depression；
  2. Aged 18-70；
  3. A score of MADRS ≥12 and <30 without suicide risk;
  4. Participants to give consent and to cooperate with the treatment and data collection;

Exclusion Criteria:

  1. Pregnant；
  2. Patients with severe diseases of heart, brain, liver, kidney or hematopoietic system, patients with acute diseases, infectious diseases and malignant tumours;
  3. Patients who are unable to stop taking relevant drugs as required during the trial; (any other drug or non-drug treatment that affects depressive symptoms, including Chinese medicine, western medicine, and physical therapies et al.)
  4. Patients with any history of psychosis or mania;
  5. Patients with cognitive disorders or personality disorders;
  6. Patients with serious suicidal ideation or behaviours.

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: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: TECAS
Patients will receive transcutaneous electrical cranial-auricular acupoint stimulation (TECAS) daily.
Procedure: TECAS Procedure

Location:

  1. Cranial electrical stimulation acupoints: Baihui (DU20) and Yintang (DU29).
  2. Auricular electrical stimulation zone: the distribution area of auricular branch of the vagus nerve.

Two electrodes electric stimulation at a frequency of 4/20 Hz will be employed on the cranial acupoints and the auricular zone respectively. The TECAS treatment will consistent of two sessions per day (30 minutes) for 8 consecutive weeks.

Other Names:
  • TECAS
Drug: Insomnia medication
For patients with severe insomnia, stabilizers and benzodiazepines could be prescribed and must be recorded in the case report form.
Other Names:
  • Benzo
Active Comparator: Anti-depressants
Each subject shall receive oral administration Escitalopram (10-20mg/day, q.d.), as prescribed by a clinical psychiatrist with respect to patients' conditions for 8 consecutive weeks.
Drug: Insomnia medication
For patients with severe insomnia, stabilizers and benzodiazepines could be prescribed and must be recorded in the case report form.
Other Names:
  • Benzo
Drug: Escitalopram
Each subject shall receive oral administration Escitalopram (10-20mg/day, q.d.), as prescribed by clinical psychiatrist with respect to patients' conditions for 8 consecutive weeks.
Other Names:
  • Escitalopram Oxalate Tablets

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical response at the end of treatment
Time Frame: 8 week
The responder is defined as a ≥50% reduction from the baseline MADRS or HAMD-17 at the end of treatment.
8 week

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Remission at the end of treatment
Time Frame: 8 week
Remission is defined as a score of 12 or fewer points on the MADRS or as 7 or fewer points on the HAMD-17.
8 week
Changes from baseline in the Montgomery-Åsberg Depression Rating Scale (MADRS) score
Time Frame: Baseline, 2 week, 4 week, 8 week, 12 week
The 10-item Montgomery-Åsberg Depression Rating Scale (MADRS) measures severity of depression in individuals 18 years and older (range, 0 to 60, with higher scores indicating more severe depression; minimal clinically significant difference, 1.6 to 1.9 points). Each item is rated on a 7-point scale. The scale is an adaptation of the Hamilton Depression Rating Scale and has a greater sensitivity to change over time. The scale takes 20 to 30 minutes to complete and score.
Baseline, 2 week, 4 week, 8 week, 12 week
Changes from baseline in the 17-item Hamilton Depression Scale (HAMD-17)
Time Frame: Baseline, 2 week, 4 week, 8 week, 12 week
The Hamilton Rating Scale for Depression, abbreviated HDRS, HRSD or HAM-D, measures depression in individuals before, during and after treatment. The scale is administered by a health care professionals and contains 21 items, but is scored based on the first 17 items, which are measured either on 5-point or 3-point scales. It takes 15 to 20 minutes to complete and score.
Baseline, 2 week, 4 week, 8 week, 12 week
Changes from baseline in the Hamilton Anxiety Rating Scale (HAMA)
Time Frame: Baseline, 2 week, 4 week, 8 week, 12 week
The HAMA is widely used in both clinical practice and research settings. The scale consists of 14 items, each defined by a series of symptoms, and measures both psychic anxiety (mental agitation and psychological distress) and somatic anxiety (physical complaints related to anxiety). Each item is scored on a scale of 0 (not present) to 4 (severe), with a total score range of 0-56, where <17 indicates mild severity, 18-24 mild to moderate severity and 25-30 moderate to severe.
Baseline, 2 week, 4 week, 8 week, 12 week
Changes from baseline in the Pittsburgh sleep quality index (PSQI)
Time Frame: Baseline, 2 week, 4 week, 8 week, 12 week
The sleep quality will be assessed using the Pittsburgh sleep quality index. Assessments will be conducted at baseline, 2-week and once every four weeks thereafter.
Baseline, 2 week, 4 week, 8 week, 12 week
Changes from baseline in the Short Form 36 Health Survey
Time Frame: Baseline, 2 week, 4 week, 8 week, 12 week
The Short Form (36) Health Survey is a 36-item, patient-reported survey of patient health. It has 36 items grouped in 8 dimensions: physical functoning, physicial and emotional limitations, social functioning, bodily pain, general and mental health.
Baseline, 2 week, 4 week, 8 week, 12 week
Adverse events
Time Frame: Weeks 1-12
Adverse events of TECAS treatment will be assessed and would be evaluated during the whole procedure, as well as laboratory tests (whole blood counts, renal and liver functions) if needed. Side Effects of Escitalopram will be assessed and would be evaluated during the whole procedure, as well as laboratory tests (whole blood counts, renal and liver functions) if needed. All clinical adverse events will be recorded in terms of intensity (mild, moderate, or severe), duration, outcome and relationship to the study.
Weeks 1-12

Collaborators and Investigators

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

Sponsor

The University of Hong Kong

Collaborators

Guang'anmen Hospital of China Academy of Chinese Medical Sciences
The First Hospital of Hebei Medical University
Beijing First Hospital of integrated Chinese and Western Medicine
Southwest Medical University, Hospital of Traditional Chinese Medicine

Investigators

  • Principal Investigator: Zhang-Jin ZHANG, BMed, PhD, School of Chinese Medicine, The University of Hong Kong

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 (Actual)

July 29, 2019

Primary Completion (Anticipated)

December 10, 2021

Study Completion (Anticipated)

December 10, 2021

Study Registration Dates

First Submitted

March 28, 2019

First Submitted That Met QC Criteria

April 8, 2019

First Posted (Actual)

April 9, 2019

Study Record Updates

Last Update Posted (Actual)

November 26, 2021

Last Update Submitted That Met QC Criteria

November 24, 2021

Last Verified

November 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2018YFC1705801

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

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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