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

NCT ID: NCT03909217

Last Updated: 2024-05-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 470 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-07-29
• Study Completion Date: 2021-12-02

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.

Conditions

Mild-to-moderate Depression

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

TECAS

Patients will receive transcutaneous electrical cranial-auricular acupoint stimulation (TECAS) daily.

Group Type: EXPERIMENTAL

TECAS Procedure

Intervention Type: 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.

Insomnia medication

Intervention Type: DRUG

For patients with severe insomnia, stabilizers and benzodiazepines could be prescribed and must be recorded in the case report form.

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.

Group Type: ACTIVE_COMPARATOR

Escitalopram

Intervention Type: DRUG

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.

Insomnia medication

Intervention Type: DRUG

For patients with severe insomnia, stabilizers and benzodiazepines could be prescribed and must be recorded in the case report form.

Interventions

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.

Intervention Type: PROCEDURE

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.

Intervention Type: DRUG

Insomnia medication

For patients with severe insomnia, stabilizers and benzodiazepines could be prescribed and must be recorded in the case report form.

Intervention Type: DRUG

Other Intervention Names

TECAS; Escitalopram Oxalate Tablets; Benzo

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Guang'anmen Hospital of China Academy of Chinese Medical Sciences

OTHER

Sponsor Role: collaborator

Beijing First Hospital of integrated Chinese and Western Medicine

OTHER

Sponsor Role: collaborator

The First Hospital of Hebei Medical University

OTHER

Sponsor Role: collaborator

Southwest Medical University

OTHER

Sponsor Role: collaborator

The University of Hong Kong

OTHER

Sponsor Role: lead

Responsible Party

Prof. Zhang Zhang-Jin

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Zhang-Jin ZHANG, BMed, PhD

Role: PRINCIPAL_INVESTIGATOR

School of Chinese Medicine, The University of Hong Kong

Locations

Department of Chinese Medicine, The University of Hong Kong-Shenzhen Hospital

Shenzhen, Guangdong, China

Department of neurology, The University of Hong Kong-Shenzhen Hospital

Shenzhen, Guangdong, China

The First Hospital of Hebei Medical University

Hebei, Shijiazhuang, China

Southwest Medical University, Hospital of Traditional Chinese Medicine

Luzhou, Sichuan, China

Beijing First Hospital of Integrated Chinese and Western Medicine

Beijing, , China

Guang'anmen Hospital of the Chinese Academy of Chinese Medical Science

Beijing, , China

Countries

China

References

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Reference Type: BACKGROUND

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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.

Reference Type: DERIVED

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Other Identifiers

2018YFC1705801

Identifier Type: -

Identifier Source: org_study_id