DepressionNCT06385223
A Novel Individualized Connectome-guided Approach for Precision Intermittent Theta Burst Stimulation for Depression
A study testing Beam F3 targeted accelerated iTBS and Individualized connectome-guided accelerated iTBS in people with Depression, run by Institute of Mental Health, Singapore at 1 site in Singapore.
Trial summary
The Investigators propose to carry out a randomized, double-blind trial to compare the clinical efficacy of an individualized connectome-guided accelerated iTBS vs an anatomically-guided (Beam F3) accelerated iTBS. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Depression
- What is being tested?
- Beam F3 targeted accelerated iTBS and Individualized connectome-guided accelerated iTBS
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteSingapore
- Study dates
- 1 Jul 2024to 31 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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 21 years.
- DSM-5 diagnosis of current Major Depressive Episode.
- Montgomery-Asberg Depression Rating Scale score of 20 or more.
- Inadequate response to an adequate trial (4 weeks) of at least one antidepressant medication.
- Able to give informed consent.
Who cannot join
- DSM-5 psychotic disorder
- Drug or alcohol abuse or dependence (preceding 3 months).
- Rapid clinical response required, e.g., high suicide risk.
- Significant neurological disorder, which may pose increased risks with TMS, e.g., epilepsy.
- Metal in the cranium, skull defects, pacemaker, cochlear implant, medication pump or other electronic device.
- Pregnancy.
- Unsuitable for MRI.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Singapore1 site, 1 recruiting
- Recruiting
Institute of Mental Health
Singapore, 539747
Phern Chern Tor, MBBS, 63892000, phern_chern_tor@imh.com.sg
Jovi Koh, 63892000, Jovi_Zheng_Jie_KOH@imh.com.sg
About this study
Official title: A Novel Individualized Connectome-guided Approach for Precision Intermittent Theta Burst Stimulation for Depression: a Double Blind, Randomized Controlled Trial
The Investigators propose to carry out a randomized, double-blind trial to compare the clinical efficacy of an individualized connectome-guided accelerated iTBS vs an anatomically-guided (Beam F3) accelerated iTBS. The study team will recruit both inpatients and outpatients who had been referred for TMS for the treatment of depression.
- Conditions
- Depression
- Being tested
- Beam F3 targeted accelerated iTBS, Individualized connectome-guided accelerated iTBS
- Keywords
- neuronavigated, iTBS, Accelerated, RCT
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Beam F3 targeted accelerated iTBSDevice
Magpro X100, Axilium Cobot, Localite camera
Individualized connectome-guided accelerated iTBSDevice
Magpro X100, Axilium Cobot, Localite camera
| Study group | Role | What they receive |
|---|---|---|
| Beam F3 targeting of accelerated iTBS | Active comparator | Patients will receive anatomically-guided (Beam F3) accelerated iTBS.
Participants will receive an accelerated iTBS treatment delivered with a MagVenture MagPro X100 system (MagVenture A/S, Denmark) equipped with a butterfly shaped MagVenture Cool-B65 A/P coil. The treatment course is comprised of 10 treatment sessions daily for 5 consecutive workdays for a total of 50 sessions. Each iTBS session is approximately 10 minutes (depth corrected Resting Motor Threshold of 90%, 60 cycles of 10 bursts of three pulses at 50 Hz, repeated at 5 Hz; 2s on and 8s off; 1800 pulses per session; with a 50-minute interval between sessions). All iTBS sessions will be performed by staff trained and credentialed in TMS according to Singapore College of Psychiatrists guidelines. Receives: Device: Beam F3 targeted accelerated iTBS |
| Individualized connectome-guided accelerated iTBS | Experimental | Patients will receive individualized connectome-guided accelerated iTBS.
Participants will receive an accelerated iTBS treatment delivered with a MagVenture MagPro X100 system (MagVenture A/S, Denmark) equipped with a butterfly shaped MagVenture Cool-B65 A/P coil. The treatment course is comprised of 10 treatment sessions daily for 5 consecutive workdays for a total of 50 sessions. Each iTBS session is approximately 10 minutes (depth corrected Resting Motor Threshold of 90%, 60 cycles of 10 bursts of three pulses at 50 Hz, repeated at 5 Hz; 2s on and 8s off; 1800 pulses per session; with a 50-minute interval between sessions). All iTBS sessions will be performed by staff trained and credentialed in TMS according to Singapore College of Psychiatrists guidelines. Receives: Device: Individualized connectome-guided accelerated iTBS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Montgomery-Åsberg Depression Rating Scale
Clinician rated depression rating scale, Scored 0 to 60, higher scores mean worse outcome
Measured: Baseline, immediately post treatment, 1 month and 3 months post intervention
Secondary outcomes (4)
Quick Inventory of Depressive Symptomatology (16-Item) (Self-Report)
Participant rated depression rating scale, scored 0-27, higher scores mean worse outcome
Measured: Baseline, daily during treatment (5 days), immediately post treatment, 1 month and 3 months post intervention
Montreal Cognitive Assessment (MoCA)
global cognitive functioning, scored 0-30, higher score means better outcome
Measured: Baseline, immediately post treatment, 1 month and 3 months post intervention
EQ-5D (EuroQol)
Quality of life scales, scored 0-100, higher scores mean better outcome
Measured: Baseline, immediately post treatment, 1 month and 3 months post intervention
Quality of Life Enjoyment and Satisfaction Questionnaire Short form (Q-LES-QS-SF)
Quality of life scales, scored 14-70, higher score means better outcome
Measured: Baseline, immediately post treatment, 1 month and 3 months post intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2024
- Study start1 Jul 2024
- Primary completion1 Jul 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DepressionStudies 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
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institute of Mental Health, Singapore
- Sponsor type
- University, hospital or other
- Collaborators
- National University of Singapore
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06385223
- Sponsor's protocol ID
- DSRB 2023/00680
- Status last verified
- Jun 2024
- First submitted
- 5 Apr 2024
- Last updated
- 1 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Novel Individualized Connectome-guided Approach for Precision Intermittent Theta Burst Stimulation for Depression: a Double Blind, Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06385223
- Acronym / sponsor ID
- DSRB 2023/00680
- Conditions
- Depression
- Keywords
- neuronavigated, iTBS, Accelerated, RCT
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Institute of Mental Health, SingaporeUniversity, hospital or other
- Collaborators
- National University of Singapore
- Study start
- 1 Jul 2024 (actual)
- Primary completion
- 1 Jul 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 25 Apr 2024 (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 Investigators propose to carry out a randomized, double-blind trial to compare the clinical efficacy of an individualized connectome-guided accelerated iTBS vs an anatomically-guided (Beam F3) accelerated iTBS. The study team will recruit both inpatients and outpatients who had been referred for TMS for the treatment of depression.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Beam F3 targeting of accelerated iTBS | Active comparator | Device: Beam F3 targeted accelerated iTBSPatients will receive anatomically-guided (Beam F3) accelerated iTBS. Participants will receive an accelerated iTBS treatment delivered with a MagVenture MagPro X100 system (MagVenture A/S, Denmark) equipped with a butterfly shaped MagVenture Cool-B65 A/P coil. The treatment course is comprised of 10 treatment sessions daily for 5 consecutive workdays for a total of 50 sessions. Each iTBS session is approximately 10 minutes (depth corrected Resting Motor Threshold of 90%, 60 cycles of 10 bursts of three pulses at 50 Hz, repeated at 5 Hz; 2s on and 8s off; 1800 pulses per session; with a 50-minute interval between sessions). All iTBS sessions will be performed by staff trained and credentialed in TMS according to Singapore College of Psychiatrists guidelines. |
| Individualized connectome-guided accelerated iTBS | Experimental | Device: Individualized connectome-guided accelerated iTBSPatients will receive individualized connectome-guided accelerated iTBS. Participants will receive an accelerated iTBS treatment delivered with a MagVenture MagPro X100 system (MagVenture A/S, Denmark) equipped with a butterfly shaped MagVenture Cool-B65 A/P coil. The treatment course is comprised of 10 treatment sessions daily for 5 consecutive workdays for a total of 50 sessions. Each iTBS session is approximately 10 minutes (depth corrected Resting Motor Threshold of 90%, 60 cycles of 10 bursts of three pulses at 50 Hz, repeated at 5 Hz; 2s on and 8s off; 1800 pulses per session; with a 50-minute interval between sessions). All iTBS sessions will be performed by staff trained and credentialed in TMS according to Singapore College of Psychiatrists guidelines. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age ≥ 21 years.
- DSM-5 diagnosis of current Major Depressive Episode.
- Montgomery-Asberg Depression Rating Scale score of 20 or more.
- Inadequate response to an adequate trial (4 weeks) of at least one antidepressant medication.
- Able to give informed consent.
Key exclusion criteria (7 listed)
- DSM-5 psychotic disorder
- Drug or alcohol abuse or dependence (preceding 3 months).
- Rapid clinical response required, e.g., high suicide risk.
- Significant neurological disorder, which may pose increased risks with TMS, e.g., epilepsy.
- Metal in the cranium, skull defects, pacemaker, cochlear implant, medication pump or other electronic device.
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 |
|---|---|---|
| Beam F3 targeted accelerated iTBSMagpro X100, Axilium Cobot, Localite camera | Device | Beam F3 targeting of accelerated iTBS |
| Individualized connectome-guided accelerated iTBSMagpro X100, Axilium Cobot, Localite camera | Device | Individualized connectome-guided accelerated iTBS |
Primary outcome
Montgomery-Åsberg Depression Rating Scale
Time frame: Baseline, immediately post treatment, 1 month and 3 months post intervention
Clinician rated depression rating scale, Scored 0 to 60, higher scores mean worse outcome
4 secondary outcomes
Quick Inventory of Depressive Symptomatology (16-Item) (Self-Report)
Time frame: Baseline, daily during treatment (5 days), immediately post treatment, 1 month and 3 months post intervention
Montreal Cognitive Assessment (MoCA)
Time frame: Baseline, immediately post treatment, 1 month and 3 months post intervention
EQ-5D (EuroQol)
Time frame: Baseline, immediately post treatment, 1 month and 3 months post intervention
Quality of Life Enjoyment and Satisfaction Questionnaire Short form (Q-LES-QS-SF)
Time frame: Baseline, immediately post treatment, 1 month and 3 months post intervention
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 1 Aug 2024.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Beam F3 targeted accelerated iTBS and Individualized connectome-guided accelerated iTBS in people with Depression, run by Institute of Mental Health, Singapore at 1 site in Singapore.
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 5 inclusion and 7 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 1 Aug 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 Singapore. 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 Phern Chern Tor, MBBS (63892000, phern_chern_tor@imh.com.sg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Montgomery-Åsberg Depression Rating Scale (time frame: Baseline, immediately post treatment, 1 month and 3 months post intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 1 Aug 2024; AzTrials last refreshed its copy on 6 Nov 2026.