Treating Depression With Transcutaneous Electrical Cranial-auricular Acupoint Stimulation (TECAS).
Ključne besede
Povzetek
Opis
Depression is a common and costly disorder with high prevalence rate and high suicide rate. Antidepressants are the first-line treatments for depression. However, approximately 50% to 60% of the patients have not achieved adequate response following antidepressant treatment.
A large body of evidence well confirms that electro-acupuncture is effective in improving depression and reducing anti-depressant treatment-caused side effects, including pain, nausea, dizziness, fatigue, anxiety and sleep disturbance.
Based on the combination of ancient and modern literature and famous traditional Chinese medicine practitioners' experience, the Evidence-based Guidelines of Clinical Practice with Acupuncture and Moxibustion-Depression (ZJ/TE003-2014) recommended Baihui (DU20) and Yintang (DU29) as main acupoints in treating patients with depression via electro-acupuncture.
Our research team have completed a series of clinical trials, including electrical stimulation on cranial and auricular acupoints for treating depression, postpartum depression, post-stroke depression, and depression with somatic pain. These studies found that cranial-auricular acupoint stimulation, as well as transcutaneous electrical stimulation, can improve depressive symptoms and accompanying symptoms in patients with depression significantly.
Unlike traditional acupuncture, transcutaneous electrical stimulation does not need needles to penetrate the skin. It places electrodes on the skin of the corresponding acupoints. In this way, traumatic pain and fear of acupuncture can be avoided. And it is more easily accepted for patients and more convenient for clinical operation. Therefore, the investigators plan to build a novel transcutaneous electrical stimulation therapy--Transcutaneous electrical cranial-auricular acupoint stimulation (TECAS).
In the proposed study, a combination of transcutaneous electrical cranial and transcutaneous electrical auricular acupoint stimulation will be employed to treat patients with mild-to-moderate depression compared with antidepressant Escitalopram, to confirm the clinical effectiveness of TECAS in mild-to-moderate depression.
Datumi
| Nazadnje preverjeno: | 11/30/2019 |
| Prvič predloženo: | 03/27/2019 |
| Predviden vpis oddan: | 04/07/2019 |
| Prvič objavljeno: | 04/08/2019 |
| Zadnja posodobitev oddana: | 12/11/2019 |
| Zadnja posodobitev objavljena: | 12/12/2019 |
| Dejanski datum začetka študija: | 08/25/2019 |
| Predvideni datum primarnega zaključka: | 12/30/2021 |
| Predvideni datum zaključka študije: | 12/30/2022 |
Stanje ali bolezen
Intervencija / zdravljenje
Procedure: TECAS
Drug: Anti-depressants
Drug: Insomnia medication
Faza
Skupine rok
| Roka | Intervencija / zdravljenje |
|---|---|
| Experimental: TECAS Patients will receive transcutaneous electrical cranial-auricular acupoint stimulation (TECAS) daily. | Procedure: TECAS Location:
Cranial electrical stimulation acupoints: Baihui (DU20) and Yintang (DU29).
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. |
| Active Comparator: Anti-depressants 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: Anti-depressants 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. |
Merila upravičenosti
| Starost, primerna za študij | 18 Years Za 18 Years |
| Spol, upravičen do študija | All |
| Sprejema zdrave prostovoljce | Da |
| Merila | 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. |
Izid
Primarni izidni ukrepi
1. Changes in the Montgomery-Åsberg Depression Rating Scale (MADRS) [Baseline, 2 week, 4 week, 8 week, 12 week]
Ukrepi sekundarnega rezultata
1. Changes in the 17-item Hamilton Depression Scale (HAMD-17) [Baseline, 2 week, 4 week, 8 week, 12 week]
2. Changes in the Pittsburgh sleep quality index (PSQI) [Baseline, 2 week, 4 week, 8 week, 12 week]
3. Changes in the Hamilton Anxiety Rating Scale (HAMA) [Baseline, 2 week, 4 week, 8 week, 12 week]
4. Changes in the Short Form 36 Health Survey [Baseline, 2 week, 4 week, 8 week, 12 week]
5. Changes in TCM diagnosis of depression [Baseline, 2 week, 4 week, 8 week, 12 week]
6. Changes in blood pressure [Baseline, 8 week]
7. Changes in electrocardiogram [Baseline, 8 week]
8. Changes in respiratory rate [Baseline, 8 week]
9. Changes in pulse rate [Baseline, 8 week]
10. Changes in blood routine tests [Baseline, 8 week]
11. Changes in liver function tests [Baseline, 8 week]
12. Changes in kidney function tests [Baseline, 8 week]
13. Changes in Rating Scale for Side Effects (SERS) and adverse events [Baseline,1,2,3,4,5,6,7,8 weeks]
