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

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

Interventions

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.

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.

DRUG

Insomnia medication

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

Sponsors & Collaborators

• Guang'anmen Hospital of China Academy of Chinese Medical Sciences

  collaborator OTHER

• Beijing First Hospital of integrated Chinese and Western Medicine

  collaborator OTHER

• The First Hospital of Hebei Medical University

  collaborator OTHER

• Southwest Medical University

  collaborator OTHER

• The University of Hong Kong

  lead OTHER

Principal Investigators

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

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

70 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2019-07-29

Primary Completion

2021-07-02

Completion

2021-12-02

Countries

• China

Study Locations