Clinical trial NCT03909217: Treating Depression With Transcutaneous Electrical Cranial-auricular Acupoint Stimulation (TECAS).
Official title: Effectiveness and Safety of Transcutaneous Electrical Cranial-auricular Acupoint Stimulation (TECAS) for Patients With Mild-to-moderate Depression.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Mild-to-moderate Depression
Keywords: Depression
Lead sponsor: The University of Hong Kong
Sponsor class: OTHER
Collaborators: name: Guang'anmen Hospital of China Academy of Chinese Medical Sciences
name: Beijing First Hospital of integrated Chinese and Western Medicine
name: The First Hospital of Hebei Medical University
name: Southwest Medical University
First posted: 2019-04-09
Enrollment: 470
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Clinical response at the end of treatment
timeFrame: 8 week
Secondary outcomes:
measure: Remission at the end of treatment
timeFrame: 8 week
measure: Changes from baseline in the Montgomery-Åsberg Depression Rating Scale (MADRS) score
timeFrame: Baseline, 2 week, 4 week, 8 week, 12 week
measure: Changes from baseline in the 17-item Hamilton Depression Scale (HAMD-17)
timeFrame: Baseline, 2 week, 4 week, 8 week, 12 week
measure: Changes from baseline in the Hamilton Anxiety Rating Scale (HAMA)
timeFrame: Baseline, 2 week, 4 week, 8 week, 12 week
measure: Changes from baseline in the Pittsburgh sleep quality index (PSQI)
timeFrame: Baseline, 2 week, 4 week, 8 week, 12 week
measure: Changes from baseline in the Short Form 36 Health Survey
timeFrame: Baseline, 2 week, 4 week, 8 week, 12 week
measure: Adverse events
timeFrame: Weeks 1-12
Other outcomes:
Locations:
city: Shenzhen
country: China
facility: Department of Chinese Medicine, The University of Hong Kong-Shenzhen Hospital
state: Guangdong
city: Shenzhen
country: China
facility: Department of neurology, The University of Hong Kong-Shenzhen Hospital
state: Guangdong
city: Hebei
country: China
facility: The First Hospital of Hebei Medical University
state: Shijiazhuang
city: Luzhou
country: China
facility: Southwest Medical University, Hospital of Traditional Chinese Medicine
state: Sichuan
city: Beijing
country: China
facility: Beijing First Hospital of Integrated Chinese and Western Medicine
city: Beijing
country: China
facility: Guang'anmen Hospital of the Chinese Academy of Chinese Medical Science
Study officials:
affiliation: School of Chinese Medicine, The University of Hong Kong
name: Zhang-Jin ZHANG, BMed, PhD
role: PRINCIPAL_INVESTIGATOR
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citation: Yang S, Qin Z, Yang X, Chan MY, Zhang S, Rong P, Hou X, Jin G, Xu F, Liu Y, Zhang ZJ. Transcutaneous Electrical Cranial-Auricular Acupoint Stimulation vs. Escitalopram for Patients With Mild-to-Moderate Depression (TECAS): Study Design for a Randomized Controlled, Non-inferiority Trial. Front Psychiatry. 2022 May 10;13:829932. doi: 10.3389/fpsyt.2022.829932. eCollection 2022.