Mild-to-moderate DepressionPhase 2/3TECASNCT03909217
Treating Depression With Transcutaneous Electrical Cranial-auricular Acupoint Stimulation (TECAS).
A Phase 2/3 study testing TECAS Procedure, Escitalopram and Insomnia medication in people with Mild-to-moderate Depression, run by The University of Hong Kong at 6 sites in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Mild-to-moderate Depression
- What is being tested?
- TECAS Procedure, Escitalopram and Insomnia medication
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 470 participants
- Where
- 6 sitesChina
- Study dates
- 29 Jul 2019to 2 Dec 2021
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Primary diagnosis as mild to moderate depression；
- Aged 18-70；
- A score of MADRS ≥12 and <30 without suicide risk;
- Participants to give consent and to cooperate with the treatment and data collection;
Who cannot join
- Pregnant；
- Patients with severe diseases of heart, brain, liver, kidney or hematopoietic system, patients with acute diseases, infectious diseases and malignant tumours;
- 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.)
- Patients with any history of psychosis or mania;
- Patients with cognitive disorders or personality disorders;
- Patients with serious suicidal ideation or behaviours.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
China6 sites
Beijing First Hospital of Integrated Chinese and Western Medicine
Beijing, 100026
Guang'anmen Hospital of the Chinese Academy of Chinese Medical Science
Beijing, 100053
The First Hospital of Hebei Medical University
Hebei, Shijiazhuang, 050051
Southwest Medical University, Hospital of Traditional Chinese Medicine
Luzhou, Sichuan, 646000
Department of Chinese Medicine, The University of Hong Kong-Shenzhen Hospital
Shenzhen, Guangdong, 518053
Department of neurology, The University of Hong Kong-Shenzhen Hospital
Shenzhen, Guangdong, 518053
About this study
Official title: Effectiveness and Safety of Transcutaneous Electrical Cranial-auricular Acupoint Stimulation (TECAS) for Patients With Mild-to-moderate Depression.
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.
Read the detailed description
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.
- Conditions
- Mild-to-moderate Depression
- Being tested
- TECAS Procedure, Escitalopram, Insomnia medication
- Keywords
- Depression
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TECAS ProcedureProcedure or surgery
Also called 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.
EscitalopramDrug
Also called Escitalopram Oxalate Tablets
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.
Insomnia medicationDrug
Also called Benzo
For patients with severe insomnia, stabilizers and benzodiazepines could be prescribed and must be recorded in the case report form.
| Study group | Role | What they receive |
|---|---|---|
| TECAS | Experimental | Patients will receive transcutaneous electrical cranial-auricular acupoint stimulation (TECAS) daily. Receives: Procedure: TECAS Procedure; Drug: Insomnia medication |
| Anti-depressants | Active comparator | 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. Receives: Drug: Escitalopram; Drug: Insomnia medication |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical response at the end of treatment
The responder is defined as a ≥50% reduction from the baseline MADRS or HAMD-17 at the end of treatment.
Measured: 8 week
Secondary outcomes (7)
Remission at the end of treatment
Remission is defined as a score of 12 or fewer points on the MADRS or as 7 or fewer points on the HAMD-17.
Measured: 8 week
Changes from baseline in the Montgomery-Åsberg Depression Rating Scale (MADRS) score
The 10-item Montgomery-Åsberg Depression Rating Scale (MADRS) measures severity of depression in individuals 18 years and older (range, 0 to 60, with higher scores indicating more severe depression; minimal clinically significant difference, 1.6 to 1.9 points). Each item is rated on a 7-point scale. The scale is an adaptation of the Hamilton Depression Rating Scale and has a greater sensitivity to change over time. The scale takes 20 to 30 minutes to complete and score.
Measured: Baseline, 2 week, 4 week, 8 week, 12 week
Changes from baseline in the 17-item Hamilton Depression Scale (HAMD-17)
The Hamilton Rating Scale for Depression, abbreviated HDRS, HRSD or HAM-D, measures depression in individuals before, during and after treatment. The scale is administered by a health care professionals and contains 21 items, but is scored based on the first 17 items, which are measured either on 5-point or 3-point scales. It takes 15 to 20 minutes to complete and score.
Measured: Baseline, 2 week, 4 week, 8 week, 12 week
Changes from baseline in the Hamilton Anxiety Rating Scale (HAMA)
The HAMA is widely used in both clinical practice and research settings. The scale consists of 14 items, each defined by a series of symptoms, and measures both psychic anxiety (mental agitation and psychological distress) and somatic anxiety (physical complaints related to anxiety). Each item is scored on a scale of 0 (not present) to 4 (severe), with a total score range of 0-56, where <17 indicates mild severity, 18-24 mild to moderate severity and 25-30 moderate to severe.
Measured: Baseline, 2 week, 4 week, 8 week, 12 week
Changes from baseline in the Pittsburgh sleep quality index (PSQI)
The sleep quality will be assessed using the Pittsburgh sleep quality index. Assessments will be conducted at baseline, 2-week and once every four weeks thereafter.
Measured: Baseline, 2 week, 4 week, 8 week, 12 week
Changes from baseline in the Short Form 36 Health Survey
The Short Form (36) Health Survey is a 36-item, patient-reported survey of patient health. It has 36 items grouped in 8 dimensions: physical functoning, physicial and emotional limitations, social functioning, bodily pain, general and mental health.
Measured: Baseline, 2 week, 4 week, 8 week, 12 week
Adverse events
Adverse events of TECAS treatment will be assessed and would be evaluated during the whole procedure, as well as laboratory tests (whole blood counts, renal and liver functions) if needed. Side Effects of Escitalopram will be assessed and would be evaluated during the whole procedure, as well as laboratory tests (whole blood counts, renal and liver functions) if needed. All clinical adverse events will be recorded in terms of intensity (mild, moderate, or severe), duration, outcome and relationship to the study.
Measured: Weeks 1-12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2019
- Study start29 Jul 2019
- Primary completion2 Jul 2021
- Study completion2 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Mild-to-moderate DepressionStudies of the same condition, open and under way.
- More trials run by The University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 470 participants (actual)
Sponsor and investigators
- Lead sponsor
- The University of Hong Kong
- Sponsor type
- University, hospital or other
- Collaborators
- Guang'anmen Hospital of China Academy of Chinese Medical Sciences, Beijing First Hospital of integrated Chinese and Western Medicine, The First Hospital of Hebei Medical University, Southwest Medical University
- Responsible party
- Principal investigator, Prof. Zhang Zhang-Jin, The University of Hong Kong
- Investigators
- Zhang-Jin ZHANG, BMed, PhD, Principal investigator, The University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03909217
- Sponsor's protocol ID
- 2018YFC1705801
- Acronym
- TECAS
- Status last verified
- May 2024
- First submitted
- 28 Mar 2019
- Last updated
- 17 May 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Wong YK, Wu JM, Zhou G, Zhu F, Zhang Q, Yang XJ, Qin Z, Zhao N, Chen H, Zhang ZJ. Antidepressant Monotherapy and Combination Therapy with Acupuncture in Depressed Patients: A Resting-State Functional Near-Infrared Spectroscopy (fNIRS) Study. Neurotherapeutics. 2021 Oct;18(4):2651-2663. doi: 10.1007/s13311-021-01098-3. Epub 2021 Aug 24.
PubMed 34431029Zhang ZJ, Man SC, Yam LL, Yiu CY, Leung RC, Qin ZS, Chan KS, Lee VHF, Kwong A, Yeung WF, So WKW, Ho LM, Dong YY. Electroacupuncture trigeminal nerve stimulation plus body acupuncture for chemotherapy-induced cognitive impairment in breast cancer patients: An assessor-participant blinded, randomized controlled trial. Brain Behav Immun. 2020 Aug;88:88-96. doi: 10.1016/j.bbi.2020.04.035. Epub 2020 Apr 16.
PubMed 32305573Zhang ZJ, Zhao H, Jin GX, Man SC, Wang YS, Wang Y, Wang HR, Li MH, Yam LL, Qin ZS, Yu KT, Wu J, Ng FB, Ziea TE, Rong PJ. Assessor- and participant-blinded, randomized controlled trial of dense cranial electroacupuncture stimulation plus body acupuncture for neuropsychiatric sequelae of stroke. Psychiatry Clin Neurosci. 2020 Mar;74(3):183-190. doi: 10.1111/pcn.12959. Epub 2019 Dec 20.
PubMed 31747095Fang J, Rong P, Hong Y, Fan Y, Liu J, Wang H, Zhang G, Chen X, Shi S, Wang L, Liu R, Hwang J, Li Z, Tao J, Wang Y, Zhu B, Kong J. Transcutaneous Vagus Nerve Stimulation Modulates Default Mode Network in Major Depressive Disorder. Biol Psychiatry. 2016 Feb 15;79(4):266-73. doi: 10.1016/j.biopsych.2015.03.025. Epub 2015 Apr 2.
PubMed 25963932Tu Y, Fang J, Cao J, Wang Z, Park J, Jorgenson K, Lang C, Liu J, Zhang G, Zhao Y, Zhu B, Rong P, Kong J. A distinct biomarker of continuous transcutaneous vagus nerve stimulation treatment in major depressive disorder. Brain Stimul. 2018 May-Jun;11(3):501-508. doi: 10.1016/j.brs.2018.01.006. Epub 2018 Jan 31.
PubMed 29398576Yang S, Qin Z, Yang X, Chan MY, Zhang S, Rong P, Hou X, Jin G, Xu F, Liu Y, Zhang ZJ. 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. Front Psychiatry. 2022 May 10;13:829932. doi: 10.3389/fpsyt.2022.829932. eCollection 2022.
PubMed 35619617
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness and Safety of Transcutaneous Electrical Cranial-auricular Acupoint Stimulation (TECAS) for Patients With Mild-to-moderate Depression.
- ClinicalTrials.gov ID
- NCT03909217
- Acronym / sponsor ID
- TECAS / 2018YFC1705801
- Conditions
- Mild-to-moderate Depression
- Keywords
- Depression
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 470 participants (actual)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Collaborators
- Guang'anmen Hospital of China Academy of Chinese Medical Sciences, Beijing First Hospital of integrated Chinese and Western Medicine, The First Hospital of Hebei Medical University, Southwest Medical University
- Study start
- 29 Jul 2019 (actual)
- Primary completion
- 2 Jul 2021 (actual)
- Study completion
- 2 Dec 2021 (actual)
- First posted
- 9 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TECAS | Experimental | Procedure: TECAS Procedure, Drug: Insomnia medicationPatients will receive transcutaneous electrical cranial-auricular acupoint stimulation (TECAS) daily. |
| Anti-depressants | Active comparator | Drug: Escitalopram, Drug: Insomnia medicationEach 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. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Primary diagnosis as mild to moderate depression；
- Aged 18-70；
- A score of MADRS ≥12 and <30 without suicide risk;
- Participants to give consent and to cooperate with the treatment and data collection;
Key exclusion criteria (6 listed)
- Pregnant；
- Patients with severe diseases of heart, brain, liver, kidney or hematopoietic system, patients with acute diseases, infectious diseases and malignant tumours;
- 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.)
- Patients with any history of psychosis or mania;
- Patients with cognitive disorders or personality disorders;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TECAS ProcedureAlso: TECASLocation: 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. | Procedure or surgery | TECAS |
| EscitalopramAlso: Escitalopram Oxalate TabletsEach 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 | Anti-depressants |
| Insomnia medicationAlso: BenzoFor patients with severe insomnia, stabilizers and benzodiazepines could be prescribed and must be recorded in the case report form. | Drug | Anti-depressants, TECAS |
Primary outcome
Clinical response at the end of treatment
Time frame: 8 week
The responder is defined as a ≥50% reduction from the baseline MADRS or HAMD-17 at the end of treatment.
7 secondary outcomes
Remission at the end of treatment
Time frame: 8 week
Changes from baseline in the Montgomery-Åsberg Depression Rating Scale (MADRS) score
Time frame: Baseline, 2 week, 4 week, 8 week, 12 week
Changes from baseline in the 17-item Hamilton Depression Scale (HAMD-17)
Time frame: Baseline, 2 week, 4 week, 8 week, 12 week
Changes from baseline in the Hamilton Anxiety Rating Scale (HAMA)
Time frame: Baseline, 2 week, 4 week, 8 week, 12 week
Changes from baseline in the Pittsburgh sleep quality index (PSQI)
Time frame: Baseline, 2 week, 4 week, 8 week, 12 week
Changes from baseline in the Short Form 36 Health Survey
Time frame: Baseline, 2 week, 4 week, 8 week, 12 week
Adverse events
Time frame: Weeks 1-12
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2024.
- Background: PubMed 34431029Wong YK, Wu JM, Zhou G, Zhu F, Zhang Q, Yang XJ, Qin Z, Zhao N, Chen H, Zhang ZJ. Antidepressant Monotherapy and Combination Therapy with Acupuncture in Depressed Patients: A Resting-State Functional Near-Infrared Spectroscopy (fNIRS) Study. Neurotherapeutics. 2021 Oct;18(4):2651-2663. doi: 10.1007/s13311-021-01098-3. Epub 2021 Aug 24.
- Background: PubMed 32305573Zhang ZJ, Man SC, Yam LL, Yiu CY, Leung RC, Qin ZS, Chan KS, Lee VHF, Kwong A, Yeung WF, So WKW, Ho LM, Dong YY. Electroacupuncture trigeminal nerve stimulation plus body acupuncture for chemotherapy-induced cognitive impairment in breast cancer patients: An assessor-participant blinded, randomized controlled trial. Brain Behav Immun. 2020 Aug;88:88-96. doi: 10.1016/j.bbi.2020.04.035. Epub 2020 Apr 16.
- Background: PubMed 31747095Zhang ZJ, Zhao H, Jin GX, Man SC, Wang YS, Wang Y, Wang HR, Li MH, Yam LL, Qin ZS, Yu KT, Wu J, Ng FB, Ziea TE, Rong PJ. Assessor- and participant-blinded, randomized controlled trial of dense cranial electroacupuncture stimulation plus body acupuncture for neuropsychiatric sequelae of stroke. Psychiatry Clin Neurosci. 2020 Mar;74(3):183-190. doi: 10.1111/pcn.12959. Epub 2019 Dec 20.
- Background: PubMed 25963932Fang J, Rong P, Hong Y, Fan Y, Liu J, Wang H, Zhang G, Chen X, Shi S, Wang L, Liu R, Hwang J, Li Z, Tao J, Wang Y, Zhu B, Kong J. Transcutaneous Vagus Nerve Stimulation Modulates Default Mode Network in Major Depressive Disorder. Biol Psychiatry. 2016 Feb 15;79(4):266-73. doi: 10.1016/j.biopsych.2015.03.025. Epub 2015 Apr 2.
- Background: PubMed 29398576Tu Y, Fang J, Cao J, Wang Z, Park J, Jorgenson K, Lang C, Liu J, Zhang G, Zhao Y, Zhu B, Rong P, Kong J. A distinct biomarker of continuous transcutaneous vagus nerve stimulation treatment in major depressive disorder. Brain Stimul. 2018 May-Jun;11(3):501-508. doi: 10.1016/j.brs.2018.01.006. Epub 2018 Jan 31.
- Derived from this study: PubMed 35619617Yang S, Qin Z, Yang X, Chan MY, Zhang S, Rong P, Hou X, Jin G, Xu F, Liu Y, Zhang ZJ. 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. Front Psychiatry. 2022 May 10;13:829932. doi: 10.3389/fpsyt.2022.829932. eCollection 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Zhang-Jin ZHANG, BMed, PhD principal investigator
The University of Hong Kong
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing TECAS Procedure, Escitalopram and Insomnia medication in people with Mild-to-moderate Depression, run by The University of Hong Kong at 6 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical response at the end of treatment (time frame: 8 week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03909217, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 May 2024.