Treating Depression With Transcutaneous Electrical Cranial-auricular Acupoint Stimulation (TECAS).
Status:
Recruiting
Trial end date:
2022-12-31
Target enrollment:
Participant gender:
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.
Phase:
Phase 2/Phase 3
Details
Lead Sponsor:
The University of Hong Kong
Collaborators:
Beijing First Hospital of integrated Chinese and Western Medicine Guang'anmen Hospital of China Academy of Chinese Medical Sciences Southwest Medical University, Hospital of Traditional Chinese Medicine The First Hospital of Hebei Medical University