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

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ClinicalTrials.gov Identifier: NCT03909217
Recruitment Status : Not yet recruiting
First Posted : April 9, 2019
Last Update Posted : May 20, 2019
Sponsor:
Collaborators:
Guang'anmen Hospital of China Academy of Chinese Medical Sciences
Beijing First Hospital of integrated Chinese and Western Medicine
The First Hospital of Hebei Medical University
Southwest Medical University, Hospital of Traditional Chinese Medicine
Information provided by (Responsible Party):
Prof. Zhang Zhang-Jin, The University of Hong Kong

Brief Summary:
One multi-center, randomized controlled clinical trial is designed to examine whether transcutaneous electrical cranial-auricular acupoint stimulation (TECAS) is superior 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.

Condition or disease Intervention/treatment Phase
Mild-to-moderate Depression Procedure: TECAS Procedure Drug: Escitalopram Drug: Insomnia medication Phase 2 Phase 3

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 470 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effectiveness and Safety of Transcutaneous Electrical Cranial-auricular Acupoint Stimulation (TECAS) for Patients With Mild-to-moderate Depression.
Estimated Study Start Date : July 1, 2019
Estimated Primary Completion Date : December 31, 2021
Estimated Study Completion Date : December 31, 2022

Resource links provided by the National Library of Medicine


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 Name: 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 Name: 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: 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 Name: Lexapro

Drug: Insomnia medication
For patients with severe insomnia, stabilizers and benzodiazepines could be prescribed and must be recorded in the case report form.
Other Name: Benzo




Primary Outcome Measures :
  1. Changes in the Montgomery-Åsberg Depression Rating Scale (MADRS) [ Time Frame: Baseline, 4 week, 8 week, 12 week ]
    The severity of depressive symptoms will be assessed using the Montgomery-Åsberg Depression Rating Scale. Assessments will be conducted at baseline and once every four weeks thereafter.


Secondary Outcome Measures :
  1. Changes in the 17-item Hamilton Depression Scale (HAMD-17) [ Time Frame: Baseline, 4 week, 8 week, 12 week ]
    The severity of depressive symptoms will be also assessed using the 17-item Hamilton Depression Scale. Assessments will be conducted at baseline and once every four weeks thereafter.

  2. Changes in the Pittsburgh sleep quality index (PSQI) [ Time Frame: Baseline, 4 week, 8 week, 12 week ]
    The sleep quality will be assessed using the Pittsburgh sleep quality index. Assessments will be conducted at baseline and once every four weeks thereafter.

  3. Changes in the Hamilton Anxiety Rating Scale (HAMA) [ Time Frame: Baseline, 4 week, 8 week, 12 week ]
    The severity of anxiety symptoms will be assessed using the 17-item Hamilton Depression Scale. Assessments will be conducted at baseline and once every four weeks thereafter.

  4. Changes in the Short Form 36 Health Survey [ Time Frame: Baseline, 4 week, 8 week, 12 week ]
    The quality of life will be assessed using the Short Form 36 Health Survey. Assessments will be conducted at baseline and once every four weeks thereafter.

  5. Changes in TCM diagnosis of depression [ Time Frame: Baseline, 4 week, 8 week, 12 week ]
    TCM diagnosis will be based on the Criteria of diagnosis and therapeutic effect of diseases and syndromes in traditional Chinese medicine(ZY/T001.8-94). Assessments will be conducted at baseline and once every four weeks thereafter.

  6. Changes in blood pressure [ Time Frame: Baseline, 8 week ]
    Blood pressure will be measured before and after the 8-week treatment.

  7. Changes in electrocardiogram [ Time Frame: Baseline, 8 week ]
    Electrocardiogram will be measured before and after the 8-week treatment.

  8. Changes in respiratory rate [ Time Frame: Baseline, 8 week ]
    Respiratory rate will be measured before and after the 8-week treatment.

  9. Changes in pulse rate [ Time Frame: Baseline, 8 week ]
    Pulse rate will be measured before and after the 8-week treatment.

  10. Changes in blood routine tests [ Time Frame: Baseline, 8 week ]
    Full blood routine tests will be carried out before and after the 8-week treatment.

  11. Changes in liver function tests [ Time Frame: Baseline, 8 week ]
    Liver function tests will be carried out before and after the 8-week treatment.

  12. Changes in kidney function tests [ Time Frame: Baseline, 8 week ]
    Kidney function tests will be carried out before and after the 8-week treatment.

  13. Changes in Rating Scale for Side Effects (SERS) and adverse events [ Time Frame: Baseline,1,2,3,4,5,6,7,8 weeks ]
    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.



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Primary diagnosis as mild to moderate depression;
  2. Aged 18-70;
  3. A score of MADRS≥10 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03909217


Contacts
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Contact: Xin-Jing YANG, PhD +852 1870150 1833 yangxj@hku.hk
Contact: Sui-Cheung MAN, BCM, PhD +852 39176445 marksman@hku.hk

Locations
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China, Guangdong
Department of Chinese Medicine, The University of Hong Kong-Shenzhen Hospital Not yet recruiting
Shenzhen, Guangdong, China, 518053
Contact: Shui-Yan ZHANG    +86 13826569649    zhangsy9@hku-szh.org   
Principal Investigator: Shui-Yan ZHANG         
Department of neurology, The University of Hong Kong-Shenzhen Hospital Not yet recruiting
Shenzhen, Guangdong, China, 518053
Contact: Ji-Fu CAI    +86 13632998623    caijf@hku-szh.org   
Principal Investigator: Shui-Yan ZHANG         
China, Shijiazhuang
The First Hospital of Hebei Medical University
Hebei, Shijiazhuang, China, 050051
China, Sichuan
Southwest Medical University, Hospital of Traditional Chinese Medicine Not yet recruiting
Luzhou, Sichuan, China, 646000
Contact: Yong ZHANG    +86 13378253175    2506655317@qq.com   
Contact: Yong LIU    +86 15883032727    1909768139@qq.com   
Principal Investigator: Yong LIU         
China
Beijing First Hospital of Integrated Chinese and Western Medicine Not yet recruiting
Beijing, China, 100026
Contact: Xue YU    +86 13718628959    yuxue200704@126.com   
Contact: Xiao-Bin HOU    +86 13501063822    cyeykjk@163.com   
Principal Investigator: Xiao-Bin HOU         
Guang'anmen Hospital of the Chinese Academy of Chinese Medical Science Not yet recruiting
Beijing, China, 100053
Contact: Yu ZHEN    +86 15011589734    gy3842@gamyy.cn   
Contact: Feng-Quan XU    +86 13683569369    xufengquan@gamyy.cn   
Principal Investigator: Feng-Quan XU         
Sponsors and Collaborators
The University of Hong Kong
Guang'anmen Hospital of China Academy of Chinese Medical Sciences
Beijing First Hospital of integrated Chinese and Western Medicine
The First Hospital of Hebei Medical University
Southwest Medical University, Hospital of Traditional Chinese Medicine
Investigators
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Principal Investigator: Zhang-Jin ZHANG, BMed, PhD School of Chinese Medicine, The University of Hong Kong

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Responsible Party: Prof. Zhang Zhang-Jin, Professor, The University of Hong Kong
ClinicalTrials.gov Identifier: NCT03909217     History of Changes
Other Study ID Numbers: 2018YFC1705801
First Posted: April 9, 2019    Key Record Dates
Last Update Posted: May 20, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Depression
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders
Citalopram
Dexetimide
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Serotonin Agents
Physiological Effects of Drugs
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Antiparkinson Agents
Anti-Dyskinesia Agents
Parasympatholytics
Autonomic Agents
Peripheral Nervous System Agents
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents