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

NCT03909217 | Completed Phase 2 DMC

• 1 other identifier: 2018YFC1705801
• Study Type: interventional
• Target: 470
• Locations: 1 country
• Sites: 6

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.

Conditions

Mild-to-moderate Depression

Keywords

Depression

Outcome Measures

Primary Outcomes (1)

• Clinical response at the end of treatment

  The responder is defined as a ≥50% reduction from the baseline MADRS or HAMD-17 at the end of treatment.

  8 week

Secondary Outcomes (7)

• Remission at the end of treatment

  8 week

• Changes from baseline in the Montgomery-Åsberg Depression Rating Scale (MADRS) score

  Baseline, 2 week, 4 week, 8 week, 12 week

• Changes from baseline in the 17-item Hamilton Depression Scale (HAMD-17)

  Baseline, 2 week, 4 week, 8 week, 12 week

• Changes from baseline in the Hamilton Anxiety Rating Scale (HAMA)

  Baseline, 2 week, 4 week, 8 week, 12 week

• Changes from baseline in the Pittsburgh sleep quality index (PSQI)

  Baseline, 2 week, 4 week, 8 week, 12 week

Study Arms (2)

TECAS

EXPERIMENTAL

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

Procedure: TECAS Procedure; Drug: Insomnia medication

Anti-depressants

ACTIVE COMPARATOR

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; Drug: Insomnia medication

Interventions

TECAS Procedure 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.

Also known as: TECAS

TECAS

Escitalopram 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.

Also known as: Escitalopram Oxalate Tablets

Anti-depressants

Insomnia medication DRUG

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

Also known as: Benzo

Anti-depressants; TECAS

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Pregnant；
• Patients with severe diseases of heart, brain, liver, kidney or hematopoietic system, patients with acute diseases, infectious diseases and malignant tumours;
• 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.)
• Patients with any history of psychosis or mania;
• Patients with cognitive disorders or personality disorders;
• Patients with serious suicidal ideation or behaviours.

Sponsors & Collaborators

• The University of Hong Kong: lead
• Guang'anmen Hospital of China Academy of Chinese Medical Sciences: collaborator
• Beijing First Hospital of integrated Chinese and Western Medicine: collaborator
• The First Hospital of Hebei Medical University: collaborator
• Southwest Medical University: collaborator

Study Sites (6)

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

Shenzhen, Guangdong, 518053, China

Location

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

Shenzhen, Guangdong, 518053, China

Location

The First Hospital of Hebei Medical University

Hebei, Shijiazhuang, 050051, China

Location

Southwest Medical University, Hospital of Traditional Chinese Medicine

Luzhou, Sichuan, 646000, China

Location

Beijing First Hospital of Integrated Chinese and Western Medicine

Beijing, 100026, China

Location

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

Beijing, 100053, China

Location

Related Publications (6)

• Wong YK, Wu JM, Zhou G, Zhu F, Zhang Q, Yang XJ, Qin Z, Zhao N, Chen H, Zhang ZJ. Antidepressant Monotherapy and Combination Therapy with Acupuncture in Depressed Patients: A Resting-State Functional Near-Infrared Spectroscopy (fNIRS) Study. Neurotherapeutics. 2021 Oct;18(4):2651-2663. doi: 10.1007/s13311-021-01098-3. Epub 2021 Aug 24.

  PMID: 34431029 BACKGROUND

• Zhang ZJ, Man SC, Yam LL, Yiu CY, Leung RC, Qin ZS, Chan KS, Lee VHF, Kwong A, Yeung WF, So WKW, Ho LM, Dong YY. Electroacupuncture trigeminal nerve stimulation plus body acupuncture for chemotherapy-induced cognitive impairment in breast cancer patients: An assessor-participant blinded, randomized controlled trial. Brain Behav Immun. 2020 Aug;88:88-96. doi: 10.1016/j.bbi.2020.04.035. Epub 2020 Apr 16.

  PMID: 32305573 BACKGROUND

• Zhang ZJ, Zhao H, Jin GX, Man SC, Wang YS, Wang Y, Wang HR, Li MH, Yam LL, Qin ZS, Yu KT, Wu J, Ng FB, Ziea TE, Rong PJ. Assessor- and participant-blinded, randomized controlled trial of dense cranial electroacupuncture stimulation plus body acupuncture for neuropsychiatric sequelae of stroke. Psychiatry Clin Neurosci. 2020 Mar;74(3):183-190. doi: 10.1111/pcn.12959. Epub 2019 Dec 20.

  PMID: 31747095 BACKGROUND

• Fang J, Rong P, Hong Y, Fan Y, Liu J, Wang H, Zhang G, Chen X, Shi S, Wang L, Liu R, Hwang J, Li Z, Tao J, Wang Y, Zhu B, Kong J. Transcutaneous Vagus Nerve Stimulation Modulates Default Mode Network in Major Depressive Disorder. Biol Psychiatry. 2016 Feb 15;79(4):266-73. doi: 10.1016/j.biopsych.2015.03.025. Epub 2015 Apr 2.

  PMID: 25963932 BACKGROUND

• Tu Y, Fang J, Cao J, Wang Z, Park J, Jorgenson K, Lang C, Liu J, Zhang G, Zhao Y, Zhu B, Rong P, Kong J. A distinct biomarker of continuous transcutaneous vagus nerve stimulation treatment in major depressive disorder. Brain Stimul. 2018 May-Jun;11(3):501-508. doi: 10.1016/j.brs.2018.01.006. Epub 2018 Jan 31.

  PMID: 29398576 BACKGROUND

• 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.

  PMID: 35619617 DERIVED

MeSH Terms

Conditions

Depression

Interventions

Escitalopram

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Propylamines; Amines; Organic Chemicals; Nitriles; Benzofurans; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Zhang-Jin ZHANG, BMed, PhD

  School of Chinese Medicine, The University of Hong Kong

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 28, 2019
• First Posted: April 9, 2019
• Study Start: July 29, 2019
• Primary Completion: July 2, 2021
• Study Completion: December 2, 2021
• Last Updated: May 17, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (6)