Major Depressive DisorderTPSNCT05006365
EffectsOfTranscranialPulseStimulationOnDepression-PilotRCT
A study testing Transcranial Pulse Stimulation in people with Major Depressive Disorder, run by The Hong Kong Polytechnic University at 1 site in Hong Kong.
Trial summary
The aim of this study is to evaluate the effects of transranial pulse stimulation (TPS) on young adults with symptoms of depression in Hong Kong. Methods: This is a single-blind randomized controlled trial design with two-armed repeated measures, and participants will be followed up at a 3-months post-stimulation… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Major Depressive Disorder
- What is being tested?
- Transcranial Pulse Stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteHong Kong
- Study dates
- 2 Aug 2021to 28 Jan 2023
- Phase
- Interventional
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged 18 or over
- Able to understand/read Chinese
- A HAM-D-17 score of ≥ 8
- Able to provide written informed consent
Who cannot join
- Clinical Diagnosis of Major Depressive Disorder (e.g., bipolar affective disorder or schizophrenia)
- Alcohol or substance dependence
- Concomitant unstable major medical conditions or major neurological conditions such as brain tumor, brain aneurysm
- Hemophilia or other blood clotting disorders or thrombosis
- Significant communicative impairments
- Participants with metal implant in brain or treated area of the head
- Participants who undertook corticosteroid treatment within the last six weeks before first TPS treatment
- Pregnant or breastfeeding women.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Transcranial Pulse Stimulation (TPS) on Young Adults with Symptoms of Depression - a Pilot Randomized Controlled Trial
The aim of this study is to evaluate the effects of transranial pulse stimulation (TPS) on young adults with symptoms of depression in Hong Kong. Methods: This is a single-blind randomized controlled trial design with two-armed repeated measures, and participants will be followed up at a 3-months post-stimulation period. Eligbility: 1) aged 18 or over; 2) able to understand/read Chinese; 3) HAM-D-17 score of ≥ 8; 4) provide written informed consent. Exclusion criteria includes: 1) individuals being prescribed a DSM-5 diagnosis other than major depressive disorder (e.g., bipolar affective disorder or schizophrenia); 2) Alcohol or substance dependence; 3) Concomitant unstable major medical conditions or major neurological conditions such as brain tumour, brain aneurysm; 4) Haemophilia or other blood clotting disorders or thrombosis; 5) Significant communicative impairments; 6) Participants with metal implant in brain or treated area of the head; 7) Participants who undertook corticosteroid treatment within the last six weeks before first TPS treatment; 8) Pregnant or breastfeeding women. Recruitment: A total of 30 subjects will be recruited from collaborative NGOs and PolyU and randomly assigned into the Intervention Group (TPS) and the Waitlist Control Group on a 1: 1 ratio. Intervention: All participants (both TPS group and the waitlist control group) will receive six 30 minute-TPS sessions (300 pulse in each session, total: 1800 pulse) in 2 weeks' time. Outcome measurements include depression, anhedonia, instrumental activities of daily living, cognition and neuroimaging.
Read the detailed description
- PRIMARY OBJECTIVE: To evaluate the effects of Transcranial Pulse Stimulation (TPS) on symptoms of depression among young adults in Hong Kong. SECONDARY OBJECTIVES:
- To improve young adults' Anhedonia symptoms after the 2-week TPS intervention and will be maintained at 3-month post-intervention follow-up
- To improve young adults' Instrumental Activities of Daily Living (IADL) after the 2-week TPS intervention and will be maintained at 3-month post-intervention follow-up.
- To improve young adults' Cognition after the 2-week TPS intervention and will be maintained at 3-month post-intervention follow-up.
- Post-MRI scan will show a remarkable structural and functional connectivity in participants' brain after the 2-week TPS intervention compared to pre-MRI scan.
Sample size estimation: To the best of investigator's knowledge, there is only one TPS uncontrolled pilot study conducted on 35 patients with AD in Austria and therefore, we cannot base on their effect size to estimate our sample size in this study. Considering the nature of this study is the first pilot RCT in using TPS in the treatment of depression,investigators aim at recruiting 30 subjects to evaluate the efficacy of our primary and secondary outcomes in this study.
Research plan and Methodology Methods Trial Design: In this study, the investigators will use a single-blind randomized controlled trial design with two-armed repeated measures. The trial design complies with the Consolidated Standards of Reporting Trials (CONSORT) statement. In this two-armed design, investigators will use TPS as an intervention group and a waitlist control group. A waitlist control group is appropriate for comparing the effect of the TPS on the intervention group to that of those not receiving the TPS treatment at the same timepoints Both groups will be measured at baseline (T1), immediately after the intervention (T2) and at the 3-month follow-up (T3). Based on the previous studies, a 3-month follow-up is sufficient to assess the long-term sustainability of the TPS intervention.
Intervention (Transcranial Pulse Stimulation) Purpose of the intervention: The key tenets of the TPS intervention is neuromodulation, i.e., using ultrasound-based brain stimulation techniques to modulate the human brain in a focal and targeted manner. Intervention dose: Each participant should have the pre-treatment MRI scan performed in the University Research Facility in Behavioural and Systems Neuroscience, PolyU prior coming to the first intervention session. All participants (both TPS group and the waitlist control group) will receive six 30 minute-TPS sessions (300 pulse in each session, total: 1800 pulse) in 2 weeks' time (i.e., 3 sessions (Monday, Wednesday, Friday) per week, total: 3 hours). Participants will be followed up at 3-month period after the intervention (Fig 1). The investigators believe that a 2-week TPS intervention is sufficient enough to test the effects of TPS on depressive symptoms.
- Conditions
- Major Depressive Disorder
- Being tested
- Transcranial Pulse Stimulation
- Keywords
- efficacy, transcranial pulse stimulation
- Medical subject headings
- Depressive Disorder, Major
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcranial Pulse StimulationDevice
A total of 30 participants (both TPS group and the waitlist control group) will receive six 30 minute-TPS sessions (300 pulse in each session, total: 1800 pulse) in 2 weeks' time (i.e., 3 sessions (Monday, Wednesday, Friday) per week, total: 3 hours), on a 1: 1 allocation ratio. Participants will be followed up at 3-month period after the intervention. A 2-week TPS intervention alongside with 3-month follow-up is sufficient enough to test the effects of TPS on depressive symptoms.
| Study group | Role | What they receive |
|---|---|---|
| Transcranial Pulse Stimulation | Experimental | Investigators will use a single-blind randomized controlled trial design with two-armed repeated measures. The trial design complies with the Consolidated Standards of Reporting Trials (CONSORT) statement. The first arm is the Intervention Group (Transcranial Pulse Stimulation) (TPS group) Receives: Device: Transcranial Pulse Stimulation |
| Waitlist Control Group | Active comparator | Second arm is the waitlist control group. Receives: Device: Transcranial Pulse Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Depression
Hamilton Depression Rating Scale 17 (HAM-D-17) is a widely used reliable measurement. Scores range from 0 and 52, with higher scores indicating more severe depression.
Measured: Participants will be measured the changes of HAM-D-17 scores at baseline, immediately after intervention and at 3-months follow-up
Secondary outcomes (4)
Anhedonia
The core symptom of depression will be assessed by the Chinese version of the Snaith-Hamilton Pleasure Scale (SHAPS). SHAPS is a self-report scale containing 14 items. Each item scores from 1 to 4. Total scores range from 14 to 56. A higher total SHAPS score indicates lower level of anhedonia.
Measured: Participants will be measured the changes of SHAPS score at baseline, immediately after intervention and at 3-months follow-up
Instrumental Activities of Daily Living (IADL)
IADL will be assessed by the 8-item Hong Kong Chinese version of the Lawton Instrumental Activities of Daily Living Scale. Each item scores from 0 or 1. Total score ranges from 0-8. A lower score indicates a higher level of dependence.
Measured: Participants will be measured the changes of IADL score at baseline, immediately after intervention and at 3-months follow-up
Cognition
Global cognition will be measured using the Hong Kong Chinese version of the Montreal Cognitive Assessment (MoCA). Montreal Cognitive Assessment is a 30-point scale, with points awarded differently depending on the type of question asked. A score between 26 to 30 indicate normal cognitive abilities. A score of 19 to 25 indicates mild cognitive impairment. Scores of between 11 and 21 suggest mild Alzheimer's disease.
Measured: Participants will be measured the changes of the MoCA scores at baseline, immediately after intervention and at 3-months follow-up
Neuroimaging
Participants will receive pre and post treatment MRI scan to measure any changes in structural and functional connectivity changes in the brain.
Measured: Participants will be measured the changes at baseline, immediately after intervention and at 3-months follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2021
- Study start2 Aug 2021
- Primary completion31 May 2022
- Study completion28 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Major Depressive DisorderStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Hong Kong Polytechnic University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Teris Cheung, PhD, Principal investigator, HongKongPolyU
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05006365
- Sponsor's protocol ID
- HongKongPU_HSEARS20210608002
- Acronym
- TPS
- Status last verified
- Sep 2024
- First submitted
- 3 Aug 2021
- Last updated
- 13 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Beisteiner R, Lozano AM. Transcranial Ultrasound Innovations Ready for Broad Clinical Application. Adv Sci (Weinh). 2020 Oct 27;7(23):2002026. doi: 10.1002/advs.202002026. eCollection 2020 Dec.
PubMed 33304757Hamilton M. Development of a rating scale for primary depressive illness. Br J Soc Clin Psychol. 1967 Dec;6(4):278-96. doi: 10.1111/j.2044-8260.1967.tb00530.x. No abstract available.
PubMed 6080235Schulz KF, Altman DG, Moher D; CONSORT Group. CONSORT 2010 Statement: Updated guidelines for reporting parallel group randomised trials. J Clin Epidemiol. 2010 Aug;63(8):834-40. doi: 10.1016/j.jclinepi.2010.02.005. Epub 2010 Mar 25. No abstract available.
PubMed 20346629Patterson B, Boyle MH, Kivlenieks M, Van Ameringen M. The use of waitlists as control conditions in anxiety disorders research. J Psychiatr Res. 2016 Dec;83:112-120. doi: 10.1016/j.jpsychires.2016.08.015. Epub 2016 Aug 21.
PubMed 27585425Liu WH, Wang LZ, Zhu YH, Li MH, Chan RC. Clinical utility of the Snaith-Hamilton-Pleasure scale in the Chinese settings. BMC Psychiatry. 2012 Oct 31;12:184. doi: 10.1186/1471-244X-12-184.
PubMed 23110667Yeung PY, Wong LLL, Chan CC, Yung CY, Leung LMJ, Tam YY, Tang LN, Li HS, Lau ML. Montreal Cognitive Assessment - Single Cutoff Achieves Screening Purpose. Neuropsychiatr Dis Treat. 2020 Nov 6;16:2681-2687. doi: 10.2147/NDT.S269243. eCollection 2020.
PubMed 33192067Graf C. The Lawton instrumental activities of daily living scale. Am J Nurs. 2008 Apr;108(4):52-62; quiz 62-3. doi: 10.1097/01.NAJ.0000314810.46029.74.
PubMed 18367931Cheung T, Ho YS, Yeung JW, Leung SF, Fong KNK, Fong T, Kranz GS, Beisteiner R, Cheng CPW. Effects of Transcranial Pulse Stimulation (TPS) on Young Adults With Symptom of Depression: A Pilot Randomised Controlled Trial Protocol. Front Neurol. 2022 Mar 25;13:861214. doi: 10.3389/fneur.2022.861214. eCollection 2022.
PubMed 35401418
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Transcranial Pulse Stimulation (TPS) on Young Adults with Symptoms of Depression - a Pilot Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05006365
- Acronym / sponsor ID
- TPS / HongKongPU_HSEARS20210608002
- Conditions
- Major Depressive Disorder
- Keywords
- efficacy, transcranial pulse stimulation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- The Hong Kong Polytechnic UniversityUniversity, hospital or other
- Study start
- 2 Aug 2021 (actual)
- Primary completion
- 31 May 2022 (actual)
- Study completion
- 28 Jan 2023 (actual)
- First posted
- 16 Aug 2021 (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.
The aim of this study is to evaluate the effects of transranial pulse stimulation (TPS) on young adults with symptoms of depression in Hong Kong. Methods: This is a single-blind randomized controlled trial design with two-armed repeated measures, and participants will be followed up at a 3-months post-stimulation period. Eligbility: 1) aged 18 or over; 2) able to understand/read Chinese; 3) HAM-D-17 score of ≥ 8; 4) provide written informed consent. Exclusion criteria includes: 1) individuals being prescribed a DSM-5 diagnosis other than major depressive disorder (e.g., bipolar affective disorder or schizophrenia); 2) Alcohol or substance dependence; 3) Concomitant unstable major medical conditions or major neurological conditions such as brain tumour, brain aneurysm; 4) Haemophilia or other blood clotting disorders or thrombosis; 5) Significant communicative impairments; 6) Participants with metal implant in brain or treated area of the head; 7) Participants who undertook corticosteroid treatment within the last six weeks before first TPS treatment; 8) Pregnant or breastfeeding women. Recruitment: A total of 30 subjects will be recruited from collaborative NGOs and PolyU and randomly assigned into the Intervention Group (TPS) and the Waitlist Control Group on a 1: 1 ratio. Intervention: All participants (both TPS group and the waitlist control group) will receive six 30 minute-TPS sessions (300 pulse in each session, total: 1800 pulse) in 2 weeks' time. Outcome measurements include depression, anhedonia, instrumental activities of daily living, cognition and neuroimaging.
Detailed description
- PRIMARY OBJECTIVE: To evaluate the effects of Transcranial Pulse Stimulation (TPS) on symptoms of depression among young adults in Hong Kong. SECONDARY OBJECTIVES:
- To improve young adults' Anhedonia symptoms after the 2-week TPS intervention and will be maintained at 3-month post-intervention follow-up
- To improve young adults' Instrumental Activities of Daily Living (IADL) after the 2-week TPS intervention and will be maintained at 3-month post-intervention follow-up.
- To improve young adults' Cognition after the 2-week TPS intervention and will be maintained at 3-month post-intervention follow-up.
- Post-MRI scan will show a remarkable structural and functional connectivity in participants' brain after the 2-week TPS intervention compared to pre-MRI scan.
Sample size estimation: To the best of investigator's knowledge, there is only one TPS uncontrolled pilot study conducted on 35 patients with AD in Austria and therefore, we cannot base on their effect size to estimate our sample size in this study. Considering the nature of this study is the first pilot RCT in using TPS in the treatment of depression,investigators aim at recruiting 30 subjects to evaluate the efficacy of our primary and secondary outcomes in this study.
Research plan and Methodology Methods Trial Design: In this study, the investigators will use a single-blind randomized controlled trial design with two-armed repeated measures. The trial design complies with the Consolidated Standards of Reporting Trials (CONSORT) statement. In this two-armed design, investigators will use TPS as an intervention group and a waitlist control group. A waitlist control group is appropriate for comparing the effect of the TPS on the intervention group to that of those not receiving the TPS treatment at the same timepoints Both groups will be measured at baseline (T1), immediately after the intervention (T2) and at the 3-month follow-up (T3). Based on the previous studies, a 3-month follow-up is sufficient to assess the long-term sustainability of the TPS intervention.
Intervention (Transcranial Pulse Stimulation) Purpose of the intervention: The key tenets of the TPS intervention is neuromodulation, i.e., using ultrasound-based brain stimulation techniques to modulate the human brain in a focal and targeted manner. Intervention dose: Each participant should have the pre-treatment MRI scan performed in the University Research Facility in Behavioural and Systems Neuroscience, PolyU prior coming to the first intervention session. All participants (both TPS group and the waitlist control group) will receive six 30 minute-TPS sessions (300 pulse in each session, total: 1800 pulse) in 2 weeks' time (i.e., 3 sessions (Monday, Wednesday, Friday) per week, total: 3 hours). Participants will be followed up at 3-month period after the intervention (Fig 1). The investigators believe that a 2-week TPS intervention is sufficient enough to test the effects of TPS on depressive symptoms.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Transcranial Pulse Stimulation | Experimental | Device: Transcranial Pulse StimulationInvestigators will use a single-blind randomized controlled trial design with two-armed repeated measures. The trial design complies with the Consolidated Standards of Reporting Trials (CONSORT) statement. The first arm is the Intervention Group (Transcranial Pulse Stimulation) (TPS group) |
| Waitlist Control Group | Active comparator | Device: Transcranial Pulse StimulationSecond arm is the waitlist control group. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Aged 18 or over
- Able to understand/read Chinese
- A HAM-D-17 score of ≥ 8
- Able to provide written informed consent
Key exclusion criteria (8 listed)
- Clinical Diagnosis of Major Depressive Disorder (e.g., bipolar affective disorder or schizophrenia)
- Alcohol or substance dependence
- Concomitant unstable major medical conditions or major neurological conditions such as brain tumor, brain aneurysm
- Hemophilia or other blood clotting disorders or thrombosis
- Significant communicative impairments
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 |
|---|---|---|
| Transcranial Pulse StimulationA total of 30 participants (both TPS group and the waitlist control group) will receive six 30 minute-TPS sessions (300 pulse in each session, total: 1800 pulse) in 2 weeks' time (i.e., 3 sessions (Monday, Wednesday, Friday) per week, total: 3 hours), on a 1: 1 allocation ratio. Participants will be followed up at 3-month period after the intervention. A 2-week TPS intervention alongside with 3-month follow-up is sufficient enough to test the effects of TPS on depressive symptoms. | Device | Transcranial Pulse Stimulation, Waitlist Control Group |
Primary outcome
Depression
Time frame: Participants will be measured the changes of HAM-D-17 scores at baseline, immediately after intervention and at 3-months follow-up
Hamilton Depression Rating Scale 17 (HAM-D-17) is a widely used reliable measurement. Scores range from 0 and 52, with higher scores indicating more severe depression.
4 secondary outcomes
Anhedonia
Time frame: Participants will be measured the changes of SHAPS score at baseline, immediately after intervention and at 3-months follow-up
Instrumental Activities of Daily Living (IADL)
Time frame: Participants will be measured the changes of IADL score at baseline, immediately after intervention and at 3-months follow-up
Cognition
Time frame: Participants will be measured the changes of the MoCA scores at baseline, immediately after intervention and at 3-months follow-up
Neuroimaging
Time frame: Participants will be measured the changes at baseline, immediately after intervention and at 3-months follow-up
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 13 Mar 2025.
- Background: PubMed 33304757Beisteiner R, Lozano AM. Transcranial Ultrasound Innovations Ready for Broad Clinical Application. Adv Sci (Weinh). 2020 Oct 27;7(23):2002026. doi: 10.1002/advs.202002026. eCollection 2020 Dec.
- Background: PubMed 6080235Hamilton M. Development of a rating scale for primary depressive illness. Br J Soc Clin Psychol. 1967 Dec;6(4):278-96. doi: 10.1111/j.2044-8260.1967.tb00530.x. No abstract available.
- Background: PubMed 20346629Schulz KF, Altman DG, Moher D; CONSORT Group. CONSORT 2010 Statement: Updated guidelines for reporting parallel group randomised trials. J Clin Epidemiol. 2010 Aug;63(8):834-40. doi: 10.1016/j.jclinepi.2010.02.005. Epub 2010 Mar 25. No abstract available.
- Background: PubMed 27585425Patterson B, Boyle MH, Kivlenieks M, Van Ameringen M. The use of waitlists as control conditions in anxiety disorders research. J Psychiatr Res. 2016 Dec;83:112-120. doi: 10.1016/j.jpsychires.2016.08.015. Epub 2016 Aug 21.
- Background: PubMed 23110667Liu WH, Wang LZ, Zhu YH, Li MH, Chan RC. Clinical utility of the Snaith-Hamilton-Pleasure scale in the Chinese settings. BMC Psychiatry. 2012 Oct 31;12:184. doi: 10.1186/1471-244X-12-184.
- Background: PubMed 33192067Yeung PY, Wong LLL, Chan CC, Yung CY, Leung LMJ, Tam YY, Tang LN, Li HS, Lau ML. Montreal Cognitive Assessment - Single Cutoff Achieves Screening Purpose. Neuropsychiatr Dis Treat. 2020 Nov 6;16:2681-2687. doi: 10.2147/NDT.S269243. eCollection 2020.
- Background: PubMed 18367931Graf C. The Lawton instrumental activities of daily living scale. Am J Nurs. 2008 Apr;108(4):52-62; quiz 62-3. doi: 10.1097/01.NAJ.0000314810.46029.74.
- Derived from this study: PubMed 35401418Cheung T, Ho YS, Yeung JW, Leung SF, Fong KNK, Fong T, Kranz GS, Beisteiner R, Cheng CPW. Effects of Transcranial Pulse Stimulation (TPS) on Young Adults With Symptom of Depression: A Pilot Randomised Controlled Trial Protocol. Front Neurol. 2022 Mar 25;13:861214. doi: 10.3389/fneur.2022.861214. 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.
Teris Cheung, PhD principal investigator
HongKongPolyU
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transcranial Pulse Stimulation in people with Major Depressive Disorder, run by The Hong Kong Polytechnic University at 1 site in Hong Kong.
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 8 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 13 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. 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.
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?
Depression (time frame: Participants will be measured the changes of HAM-D-17 scores at baseline, immediately after intervention and at 3-months follow-up). 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 NCT05006365, which also lists 8 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 13 Mar 2025.