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

• Status: Recruiting
• Trial end date: 2022-12-31
• Target enrollment: 0
• Participant gender: All

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
• Accepts Healthy Volunteers?: No

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
• Treatments: Citalopram; Dexetimide

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.