NCT03909217: TECAS

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

Completed Phase 2, PHASE3 Last updated 17 May 2024

What this trial tests

Phase 2, PHASE3 trial testing TECAS Procedure in Mild-to-moderate Depression in 470 participants. Completed in 2 December 2021.

Timeline

29 July 2019

Primary endpoint
2 July 2021

2 December 2021

Quick facts

Lead sponsor	The University of Hong Kong
Phase	Phase 2, PHASE3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	470
Start date	29 July 2019
Primary completion	2 July 2021
Estimated completion	2 December 2021
Sites	6 locations across China

Drugs / interventions tested

• TECAS Procedure
• Escitalopram (escitalopram) — full drug profile →
• Insomnia medication — full drug profile →

Conditions studied

• Mild-to-moderate Depression — all drugs for Mild-to-moderate Depression →

Sponsor

The University of Hong Kong

Who can join

Adults 18 to 70, any sex, with Mild-to-moderate Depression. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. 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.
   Yang S, Qin Z, Yang X, Chan MY, et al · · 2022 · cited 2× · PMID 35619617 · DOI 10.3389/fpsyt.2022.829932