DepressionNCT03348761
rTMS Response Trajectories in Depression
A study testing rTMS group in people with Depression, run by Chinese University of Hong Kong at 1 site in Hong Kong.
Trial summary
Notwithstanding the cumulative evidence on the safety and efficacy of transcranial magnetic stimulation in depression care, the non-response rate to transcranial magnetic stimulation (TMS) amongst treatment-resistant depression has remained substantial despite the health care cost and time incurred. Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- Depression
- What is being tested?
- rTMS group
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteHong Kong
- Study dates
- 4 Aug 2015to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- right-handed
- meet the Diagnostic and Statistical Manual of Mental Disorder, Fourth Edition (DSM-IV) criteria for major depressive disorder
- at least moderate episode or with a score of >20 on Montgomery-asberg Depression Rating Scale (MADRS) and >18 on Hamilton Depression Rating Scale(HDRS) 17-item;
- has failed to respond adequately to at least one full course (>6 weeks) of antidepressant medication or medication intolerant.
Who cannot join
- significant head trauma
- active abuse of alcohol or illegal substances
- current psychotic symptoms
- suicide ideation/recent suicide attempts
- other DSM-IV Axis I and II psychiatric diagnosis
- neurological disorders and contraindications to fMRI (e.g. pace makers, metal implants, pregnancy) or rTMS, or having undergone electroconvulsive therapy in the preceding year.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Hong Kong1 site, 1 recruiting
- Recruiting
Department of Psychiatry, CUHK
Hong Kong, 852
Wing Sze Ho, M.Sc, 852-6309-3272, stephy0306@hotmail.com
Helene J Hopman, PhD, 852-5597-1622, hjhopman@cuhk.edu.hk
About this study
Official title: Pre-treatment Biomarker for Clinical Response to Neuronavigation Repetitive Transcranial Magnetic Stimulation (rTMS) in the Acute Phase Treatment of Refractory Major Depressive Episode- Role of Intrinsic Functional Connectivity
Notwithstanding the cumulative evidence on the safety and efficacy of transcranial magnetic stimulation in depression care, the non-response rate to transcranial magnetic stimulation (TMS) amongst treatment-resistant depression has remained substantial despite the health care cost and time incurred. There remains a compelling clinical need to find valid biomarkers to inform personalized treatment. Using supervised machine learning on 4 combined features of neuroimaging markers, our group recently reported excellent prediction for clinical response in 70 patients receiving TMS to left dorsolateral prefrontal cortex for medication-resistant major depression in 2015-18 (Phase 1 study).The clinical utility of these potential neuroimaging biomarkers is still uncertain without further validation of the trained model in an independent clinical cohort.
Read the detailed description
- Sampling Clinical participants will be recruited from the Transcranial Magnetic Stimulation Day Care Centre of Tai Po Hospital based in the New Territories East Service Cluster under the public sector. Written informed consent will be obtained from all participants according to the Declaration of Helsinki. Each subject will be paid HKD$800 to subsidize their travel.
- Pre-treatment assessment
- Baseline clinical assessment (one week before the first TMS session) Apart from collecting the basic demographic profile of the research participant (age, education level, gender), the research psychiatrist will administer MADRS, DSM-IV, SCID-I/II to ascertain current/ lifetime Axis I and II psychiatric diagnosis, age at onset of MDD and number of major depressive episodes, number of failed antidepressants and clinical global impression scale (CGI) of the current episode. The psychiatrist will also review the past and current significant medical history from the Hospital Authority's Clinical Management System supplemented by participant's self-report. Participant will complete Beck Depression Inventory that has been validated in local Chinese dialect. Handedness is assessed with the Edinburgh Handedness Inventory.
- Pre-treatment MRI of Brain Pre-treatment MRI will be acquired up to two weeks before treatment on a 3.0 T Philips Achieva Medical Scanner with an eight-channel SENSE head coil (Philips Healthcare, The Netherlands) at the Prince of Wales Hospital, New Territories East Service Cluster of Hospital Authority of Hong Kong. The first scan is a high-resolution T1-weighted structural scan covering the whole brain acquired with the following parameters: repetition time = 7.54 ms, echo time = 3.53 ms, flip angle = 8⁰, 1.1 x 1.1 x 0.6 mm voxels, number of slices = 285, slice orientation = sagittal, slice thickness = 1.2 mm, Field of View = 250 mm3, and matrix size = 240 x 240. This scan will be used to register with the resting-state fMRI data, and for segmentation into grey matter, white matter and cerebrospinal fluid, and normalization to template space. Following the T1-weighted sequence, a 12-minute resting-state fMRI scan will be collected with the following protocol: repetition time = 2050ms, echo time = 25ms, flip angle = 90⁰, 3.2 mm3 voxels, slice thickness = 3.2 mm, Field of View = 205 mm², and matrix size = 64 x 64. Participants will be instructed to look at a fixation cross during the scan session.
- TMS device, stimulation target localization and stimulation parameters MagVita X100 will be used to deliver intermittent theta burst stimulation (iTBS) to left DLPFC in the Transcranial Magnetic Stimulation Day Care Centre of Tai Po Hospital. The treatment facility is fully funded and operated by the Hospital Authority as part of the drug-resistant protocol accessible to all patients receiving specialist psychiatric service in the public sector and was established since 2021. All treatment sessions are delivered by qualified operators (psychiatrists or nurses) as part of the core clinical service. The treatment protocol adopts F3 beam target with MagVita X100 following the manufacturer's guide that utilizes a formulaic estimation of F3 location system. The US-FDA approved 3-minute intermittent theta-burst protocol (i-TBS) 18 comprises of 18 cycles of 10 bursts. Each burst is triplet of pulses discharged at 50 hz and the burst frequency is 5Hz. Between two cycles of bursts is 8-second inter-train rest. The device output is set at 120% above the resting motor threshold determined on the observable motor excitability on M1 motor cortex corresponding to the right-hand abductor pollicis brevis (at least 5 out of 10 trials reaching 50 microvolt read from MEG in response to single pulse TMS). The resting motor threshold is determined only once every week. The full course includes 20 daily sessions over four weeks.
- Follow-up assessments are scheduled at the end of week 2, week 4, week 6, week 8, and week 12 to delineate the trajectory of depressive symptoms over a course of 12 weeks. Primary outcome measures are the scores on MADRS and CGI at the end of week 4 and week 12. Secondary outcome measure is score on BDI at the end of week 4 and week 12. Patients are classified as short-term responders where clinical response is defined as CGI= 2 and >/=50% reduction of MADRS score from baseline at the end of week 4. For those who fulfill clinical response where CGI= 2 and there is >/=50% reduction of MADRS score from baseline at the end of week 12 are classified as long-term responders. Patients are classified as short-term remitters where clinical remission is defined as CGI= 1 and MADRS score<7, respectively at the end of week 4. For those who fulfill clinical remission where CGI= 1 and MADRS score is <7 at the end of week 12 are classified as long-term remitters.
- Serum BDNF level would be evaluated at baseline (within 2 weeks before treatment), at the end of week 2, week 4 and week 12 as a neurochemical biomarker of neuroplastic response. Blood samples will be collected in anticoagulant-free tubes and kept at room temperature for 1 hour before further blood sample processing. The serum collected will be used for serum marker assay. The blood samples collected in anticoagulant-free tubes would be centrifuged at 3500g, at 4°C for 10 minutes within 3 hours of blood collection to obtain serum and stored at -70°C until assay. Commercial ELISA kit will be used to assay the levels of BDNF. Measurement will be performed accordingly to manufacturer's instructions. Samples and standards will be run in duplicate and BDNF concentrations will be calculated using the standard curve. BDNF (Val66Met) will be genotyped to explore its relationship with neuroplastic change and clinical response in this study. In brief, DNA will be extracted by commercial DNA extraction kit from blood samples according to manufacturer's instruction. It will then be genotyped by Taqman genotyping assay.
- Conditions
- Depression
- Being tested
- rTMS group
- Keywords
- Repetitive Transcranial Magnetic Stimulation, resting-state Functional magnetic resonance imaging, treatment response, neurostimulation, dorsolateral prefrontal cortex, subgenual anterior cingulate cortex
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
rTMS groupDevice
| Study group | Role | What they receive |
|---|---|---|
| rTMS Group | Experimental | Phase I: A Magstim Super-Rapid device with a 70-mm figure-of-eight double air film coil (Magstim Ltd, UK) and Brainsight neuronavigation (Rogue Resolutions Ltd, Canada) are used. Stimulation parameters: 10 Hz, 120% resting motor threshold, 30 trains of 5 seconds with 25 seconds rest, 3000 pulses per day delivered 5 days per week (total: 60000 pulses).
Phase II: MagVita X100 (FDA approved device) will be used to deliver intermittent theta burst stimulation (iTBS) to left DLPFC, comprising of 18 cycles of 10 bursts. Each burst is triplet of pulses discharged at 50 hz and the burst frequency is 5Hz. Between two cycles of bursts is 8-second inter-train rest. The device output is set at 120% above the resting motor threshold Receives: Device: rTMS group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Montgomery-Ashberg Depression Rating Scale
Questionnaire used to measure the severity of depressive symptoms and treatment response in patients with mood disorders consisting of 10 items. The score range is 0-60 and higher score indicates more severe depression.
Measured: Percentage change baseline versus week 4
Montgomery-Ashberg Depression Rating Scale
Questionnaire used to measure the severity of depressive symptoms and treatment response in patients with mood disorders consisting of 10 items. The score range is 0-60 and higher score indicates more severe depression.
Measured: Percentage change baseline versus week 6
Montgomery-Ashberg Depression Rating Scale
Questionnaire used to measure the severity of depressive symptoms and treatment response in patients with mood disorders consisting of 10 items. The score range is 0-60 and higher score indicates more severe depression.
Measured: Percentage change baseline versus week 8
Montgomery-Ashberg Depression Rating Scale
Questionnaire used to measure the severity of depressive symptoms and treatment response in patients with mood disorders consisting of 10 items. The score range is 0-60 and higher score indicates more severe depression.
Measured: Percentage change baseline versus week 12
Secondary outcomes (4)
Clinical Global Impression Scale
A 7-point scale that requires the clinician to rate the severity of the patient's illness at the time of assessment, relative to the clinician's past experience with patients who have the same diagnosis. Score of 2 indicates significant clinical response while score of 1 indicates clinical remission.
Measured: Percentage change baseline versus week 4
Clinical Global Impression Scale
A 7-point scale that requires the clinician to rate the severity of the patient's illness at the time of assessment, relative to the clinician's past experience with patients who have the same diagnosis. Score of 2 indicates significant clinical response while score of 1 indicates clinical remission.
Measured: Percentage change baseline versus week 6
Clinical Global Impression Scale
A 7-point scale that requires the clinician to rate the severity of the patient's illness at the time of assessment, relative to the clinician's past experience with patients who have the same diagnosis. Score of 2 indicates significant clinical response while score of 1 indicates clinical remission.
Measured: Percentage change baseline versus week 8
Clinical Global Impression Scale
A 7-point scale that requires the clinician to rate the severity of the patient's illness at the time of assessment, relative to the clinician's past experience with patients who have the same diagnosis. Score of 2 indicates significant clinical response while score of 1 indicates clinical remission.
Measured: Percentage change baseline versus week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2017
- Study start4 Aug 2015
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for DepressionStudies of the same condition, open and under way.
- More trials run by Chinese 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 N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- All participants receive a 4-week repetitive transcranial magnetic stimulation to the left dorolateral prefrontal cortex with pre-treatment resting state MRI Brain taken, that will be subsequently used to model the clinical outcome prediction taking into account other biomarkers.
- Masking
- None (open label)
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, CHAN SAU MAN, SANDRA, Chinese University of Hong Kong
- Investigators
- Sau Man S Chan, Principal investigator, Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03348761
- Sponsor's protocol ID
- CRE-2014.041
- Status last verified
- Feb 2024
- First submitted
- 12 Nov 2017
- Last updated
- 12 Feb 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: As they are all clinical subjects, their data should be strictly confidential.
Publications
Montgomery SA, Asberg M. A new depression scale designed to be sensitive to change. Br J Psychiatry. 1979 Apr;134:382-9. doi: 10.1192/bjp.134.4.382.
PubMed 444788HAMILTON M. A rating scale for depression. J Neurol Neurosurg Psychiatry. 1960 Feb;23(1):56-62. doi: 10.1136/jnnp.23.1.56. No abstract available.
PubMed 14399272So E, Kam I, Leung CM, Chung D, Liu Z, Fong S. The Chinese-Bilingual SCID-I/P Project: stage 1- reliability for mood disorders and schizophrenia. East Asian Archives of Psychiatry 2003; 13: 7-18.
Wong HM, Chow LY. Borderline personality disorder subscale (Chinese version) of the structured clinical interview for DSM-IV axis II personality disorders: a validation study in Cantonese-speaking Hong Kong Chinese. East Asian Arch Psychiatry. 2011 Jun;21(2):52-7.
PubMed 21838207Ballenger JC. Clinical guidelines for establishing remission in patients with depression and anxiety. J Clin Psychiatry. 1999;60 Suppl 22:29-34.
PubMed 10634353Beck A, Steer R, Brown G. RCMAR Measurement Tools Beck Depression Inventory - 2nd Edition (BDI-II). The Psychological Corporation, San Antonio 1996.
Wu PC, Chang L. Psychometric Properties of the Chinese Version of the Beck Depression Inventory-II Using the Rasch Model. Measurement & Evaluation in Counseling & Development 2008; 41:13-31.
Trull TJ, Geary DC. Comparison of the big-five factor structure across samples of Chinese and American adults. J Pers Assess. 1997 Oct;69(2):324-41. doi: 10.1207/s15327752jpa6902_6.
PubMed 9392894Lo CS, Ho SM, Hollon SD. The effects of rumination and negative cognitive styles on depression: a mediation analysis. Behav Res Ther. 2008 Apr;46(4):487-95. doi: 10.1016/j.brat.2008.01.013. Epub 2008 Jan 30.
PubMed 18316063Robinson LA, Alloy LB. Negative cognitive styles and stress-reactive rumination interact to predict depression: a prospective study. Cognitive therapy and research 2003; 27: 275-292.
Murphy K, Fox MD. Towards a consensus regarding global signal regression for resting state functional connectivity MRI. Neuroimage. 2017 Jul 1;154:169-173. doi: 10.1016/j.neuroimage.2016.11.052. Epub 2016 Nov 22.
PubMed 27888059Behzadi Y, Restom K, Liau J, Liu TT. A component based noise correction method (CompCor) for BOLD and perfusion based fMRI. Neuroimage. 2007 Aug 1;37(1):90-101. doi: 10.1016/j.neuroimage.2007.04.042. Epub 2007 May 3.
PubMed 17560126Whitfield-Gabrieli S, Nieto-Castanon A. Conn: a functional connectivity toolbox for correlated and anticorrelated brain networks. Brain Connect. 2012;2(3):125-41. doi: 10.1089/brain.2012.0073. Epub 2012 Jul 19.
PubMed 22642651Fox MD, Buckner RL, White MP, Greicius MD, Pascual-Leone A. Efficacy of transcranial magnetic stimulation targets for depression is related to intrinsic functional connectivity with the subgenual cingulate. Biol Psychiatry. 2012 Oct 1;72(7):595-603. doi: 10.1016/j.biopsych.2012.04.028. Epub 2012 Jun 1.
PubMed 22658708
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pre-treatment Biomarker for Clinical Response to Neuronavigation Repetitive Transcranial Magnetic Stimulation (rTMS) in the Acute Phase Treatment of Refractory Major Depressive Episode- Role of Intrinsic Functional Connectivity
- ClinicalTrials.gov ID
- NCT03348761
- Acronym / sponsor ID
- CRE-2014.041
- Conditions
- Depression
- Keywords
- Repetitive Transcranial Magnetic Stimulation, resting-state Functional magnetic resonance imaging, treatment response, neurostimulation, dorsolateral prefrontal cortex, subgenual anterior cingulate cortex
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Study start
- 4 Aug 2015 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 21 Nov 2017 (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.
Notwithstanding the cumulative evidence on the safety and efficacy of transcranial magnetic stimulation in depression care, the non-response rate to transcranial magnetic stimulation (TMS) amongst treatment-resistant depression has remained substantial despite the health care cost and time incurred. There remains a compelling clinical need to find valid biomarkers to inform personalized treatment. Using supervised machine learning on 4 combined features of neuroimaging markers, our group recently reported excellent prediction for clinical response in 70 patients receiving TMS to left dorsolateral prefrontal cortex for medication-resistant major depression in 2015-18 (Phase 1 study).The clinical utility of these potential neuroimaging biomarkers is still uncertain without further validation of the trained model in an independent clinical cohort.
Detailed description
- Sampling Clinical participants will be recruited from the Transcranial Magnetic Stimulation Day Care Centre of Tai Po Hospital based in the New Territories East Service Cluster under the public sector. Written informed consent will be obtained from all participants according to the Declaration of Helsinki. Each subject will be paid HKD$800 to subsidize their travel.
- Pre-treatment assessment
- Baseline clinical assessment (one week before the first TMS session) Apart from collecting the basic demographic profile of the research participant (age, education level, gender), the research psychiatrist will administer MADRS, DSM-IV, SCID-I/II to ascertain current/ lifetime Axis I and II psychiatric diagnosis, age at onset of MDD and number of major depressive episodes, number of failed antidepressants and clinical global impression scale (CGI) of the current episode. The psychiatrist will also review the past and current significant medical history from the Hospital Authority's Clinical Management System supplemented by participant's self-report. Participant will complete Beck Depression Inventory that has been validated in local Chinese dialect. Handedness is assessed with the Edinburgh Handedness Inventory.
- Pre-treatment MRI of Brain Pre-treatment MRI will be acquired up to two weeks before treatment on a 3.0 T Philips Achieva Medical Scanner with an eight-channel SENSE head coil (Philips Healthcare, The Netherlands) at the Prince of Wales Hospital, New Territories East Service Cluster of Hospital Authority of Hong Kong. The first scan is a high-resolution T1-weighted structural scan covering the whole brain acquired with the following parameters: repetition time = 7.54 ms, echo time = 3.53 ms, flip angle = 8⁰, 1.1 x 1.1 x 0.6 mm voxels, number of slices = 285, slice orientation = sagittal, slice thickness = 1.2 mm, Field of View = 250 mm3, and matrix size = 240 x 240. This scan will be used to register with the resting-state fMRI data, and for segmentation into grey matter, white matter and cerebrospinal fluid, and normalization to template space. Following the T1-weighted sequence, a 12-minute resting-state fMRI scan will be collected with the following protocol: repetition time = 2050ms, echo time = 25ms, flip angle = 90⁰, 3.2 mm3 voxels, slice thickness = 3.2 mm, Field of View = 205 mm², and matrix size = 64 x 64. Participants will be instructed to look at a fixation cross during the scan session.
- TMS device, stimulation target localization and stimulation parameters MagVita X100 will be used to deliver intermittent theta burst stimulation (iTBS) to left DLPFC in the Transcranial Magnetic Stimulation Day Care Centre of Tai Po Hospital. The treatment facility is fully funded and operated by the Hospital Authority as part of the drug-resistant protocol accessible to all patients receiving specialist psychiatric service in the public sector and was established since 2021. All treatment sessions are delivered by qualified operators (psychiatrists or nurses) as part of the core clinical service. The treatment protocol adopts F3 beam target with MagVita X100 following the manufacturer's guide that utilizes a formulaic estimation of F3 location system. The US-FDA approved 3-minute intermittent theta-burst protocol (i-TBS) 18 comprises of 18 cycles of 10 bursts. Each burst is triplet of pulses discharged at 50 hz and the burst frequency is 5Hz. Between two cycles of bursts is 8-second inter-train rest. The device output is set at 120% above the resting motor threshold determined on the observable motor excitability on M1 motor cortex corresponding to the right-hand abductor pollicis brevis (at least 5 out of 10 trials reaching 50 microvolt read from MEG in response to single pulse TMS). The resting motor threshold is determined only once every week. The full course includes 20 daily sessions over four weeks.
- Follow-up assessments are scheduled at the end of week 2, week 4, week 6, week 8, and week 12 to delineate the trajectory of depressive symptoms over a course of 12 weeks. Primary outcome measures are the scores on MADRS and CGI at the end of week 4 and week 12. Secondary outcome measure is score on BDI at the end of week 4 and week 12. Patients are classified as short-term responders where clinical response is defined as CGI= 2 and >/=50% reduction of MADRS score from baseline at the end of week 4. For those who fulfill clinical response where CGI= 2 and there is >/=50% reduction of MADRS score from baseline at the end of week 12 are classified as long-term responders. Patients are classified as short-term remitters where clinical remission is defined as CGI= 1 and MADRS score<7, respectively at the end of week 4. For those who fulfill clinical remission where CGI= 1 and MADRS score is <7 at the end of week 12 are classified as long-term remitters.
- Serum BDNF level would be evaluated at baseline (within 2 weeks before treatment), at the end of week 2, week 4 and week 12 as a neurochemical biomarker of neuroplastic response. Blood samples will be collected in anticoagulant-free tubes and kept at room temperature for 1 hour before further blood sample processing. The serum collected will be used for serum marker assay. The blood samples collected in anticoagulant-free tubes would be centrifuged at 3500g, at 4°C for 10 minutes within 3 hours of blood collection to obtain serum and stored at -70°C until assay. Commercial ELISA kit will be used to assay the levels of BDNF. Measurement will be performed accordingly to manufacturer's instructions. Samples and standards will be run in duplicate and BDNF concentrations will be calculated using the standard curve. BDNF (Val66Met) will be genotyped to explore its relationship with neuroplastic change and clinical response in this study. In brief, DNA will be extracted by commercial DNA extraction kit from blood samples according to manufacturer's instruction. It will then be genotyped by Taqman genotyping assay.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- All participants receive a 4-week repetitive transcranial magnetic stimulation to the left dorolateral prefrontal cortex with pre-treatment resting state MRI Brain taken, that will be subsequently used to model the clinical outcome prediction taking into account other biomarkers.
| Arm | Type | Receives |
|---|---|---|
| rTMS Group | Experimental | Device: rTMS groupPhase I: A Magstim Super-Rapid device with a 70-mm figure-of-eight double air film coil (Magstim Ltd, UK) and Brainsight neuronavigation (Rogue Resolutions Ltd, Canada) are used. Stimulation parameters: 10 Hz, 120% resting motor threshold, 30 trains of 5 seconds with 25 seconds rest, 3000 pulses per day delivered 5 days per week (total: 60000 pulses). Phase II: MagVita X100 (FDA approved device) will be used to deliver intermittent theta burst stimulation (iTBS) to left DLPFC, comprising of 18 cycles of 10 bursts. Each burst is triplet of pulses discharged at 50 hz and the burst frequency is 5Hz. Between two cycles of bursts is 8-second inter-train rest. The device output is set at 120% above the resting motor threshold |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- right-handed
- meet the Diagnostic and Statistical Manual of Mental Disorder, Fourth Edition (DSM-IV) criteria for major depressive disorder
- at least moderate episode or with a score of >20 on Montgomery-asberg Depression Rating Scale (MADRS) and >18 on Hamilton Depression Rating Scale(HDRS) 17-item;
- has failed to respond adequately to at least one full course (>6 weeks) of antidepressant medication or medication intolerant.
Key exclusion criteria (6 listed)
- significant head trauma
- active abuse of alcohol or illegal substances
- current psychotic symptoms
- suicide ideation/recent suicide attempts
- other DSM-IV Axis I and II psychiatric diagnosis
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 |
|---|---|---|
| rTMS group | Device | rTMS Group |
Primary outcome
Montgomery-Ashberg Depression Rating Scale
Time frame: Percentage change baseline versus week 4
Questionnaire used to measure the severity of depressive symptoms and treatment response in patients with mood disorders consisting of 10 items. The score range is 0-60 and higher score indicates more severe depression.
Montgomery-Ashberg Depression Rating Scale
Time frame: Percentage change baseline versus week 6
Questionnaire used to measure the severity of depressive symptoms and treatment response in patients with mood disorders consisting of 10 items. The score range is 0-60 and higher score indicates more severe depression.
Montgomery-Ashberg Depression Rating Scale
Time frame: Percentage change baseline versus week 8
Questionnaire used to measure the severity of depressive symptoms and treatment response in patients with mood disorders consisting of 10 items. The score range is 0-60 and higher score indicates more severe depression.
Montgomery-Ashberg Depression Rating Scale
Time frame: Percentage change baseline versus week 12
Questionnaire used to measure the severity of depressive symptoms and treatment response in patients with mood disorders consisting of 10 items. The score range is 0-60 and higher score indicates more severe depression.
4 secondary outcomes
Clinical Global Impression Scale
Time frame: Percentage change baseline versus week 4
Clinical Global Impression Scale
Time frame: Percentage change baseline versus week 6
Clinical Global Impression Scale
Time frame: Percentage change baseline versus week 8
Clinical Global Impression Scale
Time frame: Percentage change baseline versus week 12
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2024.
- Background: PubMed 444788Montgomery SA, Asberg M. A new depression scale designed to be sensitive to change. Br J Psychiatry. 1979 Apr;134:382-9. doi: 10.1192/bjp.134.4.382.
- Background: PubMed 14399272HAMILTON M. A rating scale for depression. J Neurol Neurosurg Psychiatry. 1960 Feb;23(1):56-62. doi: 10.1136/jnnp.23.1.56. No abstract available.
- BackgroundSo E, Kam I, Leung CM, Chung D, Liu Z, Fong S. The Chinese-Bilingual SCID-I/P Project: stage 1- reliability for mood disorders and schizophrenia. East Asian Archives of Psychiatry 2003; 13: 7-18.
- Background: PubMed 21838207Wong HM, Chow LY. Borderline personality disorder subscale (Chinese version) of the structured clinical interview for DSM-IV axis II personality disorders: a validation study in Cantonese-speaking Hong Kong Chinese. East Asian Arch Psychiatry. 2011 Jun;21(2):52-7.
- Background: PubMed 10634353Ballenger JC. Clinical guidelines for establishing remission in patients with depression and anxiety. J Clin Psychiatry. 1999;60 Suppl 22:29-34.
- BackgroundBeck A, Steer R, Brown G. RCMAR Measurement Tools Beck Depression Inventory - 2nd Edition (BDI-II). The Psychological Corporation, San Antonio 1996.
- BackgroundWu PC, Chang L. Psychometric Properties of the Chinese Version of the Beck Depression Inventory-II Using the Rasch Model. Measurement & Evaluation in Counseling & Development 2008; 41:13-31.
- Background: PubMed 9392894Trull TJ, Geary DC. Comparison of the big-five factor structure across samples of Chinese and American adults. J Pers Assess. 1997 Oct;69(2):324-41. doi: 10.1207/s15327752jpa6902_6.
- Background: PubMed 18316063Lo CS, Ho SM, Hollon SD. The effects of rumination and negative cognitive styles on depression: a mediation analysis. Behav Res Ther. 2008 Apr;46(4):487-95. doi: 10.1016/j.brat.2008.01.013. Epub 2008 Jan 30.
- BackgroundRobinson LA, Alloy LB. Negative cognitive styles and stress-reactive rumination interact to predict depression: a prospective study. Cognitive therapy and research 2003; 27: 275-292.
- Background: PubMed 27888059Murphy K, Fox MD. Towards a consensus regarding global signal regression for resting state functional connectivity MRI. Neuroimage. 2017 Jul 1;154:169-173. doi: 10.1016/j.neuroimage.2016.11.052. Epub 2016 Nov 22.
- Background: PubMed 17560126Behzadi Y, Restom K, Liau J, Liu TT. A component based noise correction method (CompCor) for BOLD and perfusion based fMRI. Neuroimage. 2007 Aug 1;37(1):90-101. doi: 10.1016/j.neuroimage.2007.04.042. Epub 2007 May 3.
- Individual participant dataSharing planned: No. As they are all clinical subjects, their data should be strictly confidential.
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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.
Sau Man S Chan principal investigator
Chinese University of Hong Kong
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing rTMS group in people with Depression, run by Chinese University of Hong Kong 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 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: looking for participants now, as of the sponsor's last update on 12 Feb 2024. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact The Department of Psychiatry (852-2607-6027, psychiatry@cuhk.edu.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Montgomery-Ashberg Depression Rating Scale (time frame: Percentage change baseline versus week 4). The study lists 4 primary outcomes in all. 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 NCT03348761, which also lists 14 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 12 Feb 2024.