Major Depression ModerateNCT07140575
rTMS for Youth Inpatients With Depression
A study testing repetitive transcranial magnetic stimulation (rTMS) in people with Major Depression Moderate and Feasibility Studies, run by Sunnybrook Health Sciences Centre at 1 site in Canada.
Trial summary
Youth aged 15-24 are likelier to have depression than all age groups in Canada. One-third of depressed youth do not respond to psychotherapy and/or antidepressant medications. A treatment called repetitive transcranial magnetic stimulation or rTMS has proven helpful in adolescents and young adults whose depressive… Read more about this study
- Who is it for?
- Ages 14 to 19 years
- Conditions the study is for
- Major Depression Moderate, Feasibility Studies
- What is being tested?
- repetitive transcranial magnetic stimulation (rTMS)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteCanada
- Study dates
- Aug 2025to Dec 2027
- 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 14 to 19 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- age 14-19 years
- primary diagnosis of major depressive disorder or of bipolar I or II disorder, current episode depressed with no psychotic or mixed features
- current episode of depression lasting at least 4 weeks
- failed ≥1 evidence-based psychotherapy or antidepressant
- have a GRID-HAMD-17 (17-item Hamilton Depression Rating Scale) score of ≥16 (moderate-severe range)
- currently an inpatient or suitable for an elective inpatient admission
Who cannot join
- lifetime diagnosis of a psychotic disorder, anorexia nervosa, bulimia nervosa diagnosis of a substance use disorder (except caffeine and tobacco) within the past year
- obsessive compulsive disorder or personality disorder that is the main source and driver of distress
- active psychosis and/or mania
- history of epilepsy or any other neurologic condition that includes a history of seizures
- use of medications that lower the seizure threshold
- pregnancy or nursing
Show all 9Show fewer
- history of severe headaches within the previous year
- improvement in depressive symptom severity between screening and baseline by 25% or more
- inability to adhere to the protocol
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
Sunnybrook Health Sciences Centre
Toronto, Ontario, M4N 3M5
Madlene Research coordinator, 4164806100, madlene.abramian@sri.utoronto.ca
About this study
Official title: Seamless Integration of Repetitive Transcranial Magnetic Stimulation (rTMS) for Youth Inpatients With Depression: A Feasibility Study
Youth aged 15-24 are likelier to have depression than all age groups in Canada. One-third of depressed youth do not respond to psychotherapy and/or antidepressant medications. A treatment called repetitive transcranial magnetic stimulation or rTMS has proven helpful in adolescents and young adults whose depressive symptoms have been difficult to treat with psychotherapy and/or antidepressants. Unfortunately, youth find rTMS difficult to access because it is not funded by the Ontario Health Insurance Plan, is typically only offered to adults, and the treatment schedule usually involves once-daily sessions, 5 days/week, for 4-6 weeks, which is associated with travel and opportunity costs e.g. missing school. This project looks at the feasibility of a new treatment pathway that allows youth with difficult-to-treat depression in hospital to receive rTMS twice-daily while engaging in on-unit schooling and therapeutic support. This "accelerated" way of providing rTMS is safe, has equal effectiveness to once-daily rTMS, and can shorten the time needed for treatment. This pathway is for youth already staying in hospital for difficult-to-treat depression or youth outside hospital who have difficult-to-treat depression that interferes with daily function to such a degree that they would benefit from staying in hospital. The investigators anticipate integrating rTMS and inpatient care for youth will be feasible, that it will be acceptable and accessible to youth and families, and there will be sufficient demand for this new treatment pathway. If successful, this project will inform care for youth with difficult-to-treat depression in Ontario and beyond.
- Conditions
- Major Depression Moderate, Feasibility Studies
- Being tested
- repetitive transcranial magnetic stimulation (rTMS)
- Keywords
- feasibility study, major depressive disorder, adolescent, youth, repetitive transcranial magnetic stimulation, neuromodulation, rTMS, accelerated, inpatient
- 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.
repetitive transcranial magnetic stimulation (rTMS)Device
twice daily rTMS, intermittent theta burst stimulation targeting the left dorsolateral prefrontal cortex with a figure-8 coil
| Study group | Role | What they receive |
|---|---|---|
| repetitive transcranial magnetic stimulation (rTMS) | Experimental | twice daily rTMS (intermittent theta burst stimulation targeting the left dorsolateral prefrontal cortex) Receives: Device: repetitive transcranial magnetic stimulation (rTMS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasible: 90% of the time, rTMS treatment will be started within 3 business days of a patient consenting during an existing inpatient stay or within 3 business days of the start of an elective inpatient stay
The investigators anticipate the treatment path will be feasible, operationalized as the ability to meet the following metric:
Starting inpatient rTMS treatment within 3 business days of consenting during an existing inpatient stay or within 3 business days of the start of an elective inpatient stay - this metric will be met 90% of the time
Measured: From enrollment to start of rTMS treatment, assessed for 8 weeks
Feasible: 90% completion of weekly Hamilton Depression Rating Scale during treatment by clinician
The investigators anticipate the treatment path will be feasible, operationalized as the ability to meet the following metric:
Completion of the clinician-administered 17-item Hamilton Depression Rating Scale weekly during rTMS treatment with 90% completion rate. The 17-item Hamilton Depression Rating Scale has a minimum score of 0 and maximum score of 52 with higher scores reflecting greater symptom burden.
Measured: From start of rTMS treatment to end of rTMS treatment, assessed for 4 weeks
Acceptable: 25% or lower drop-out rate from completing treatment
The investigators anticipate the treatment pathway will be acceptable to patients and families. Acceptability is operationalized as a 25% or lower drop-out rate from completing treatment.
Measured: From enrollment to end of rTMS treatment, assessed for 12 weeks
Accessible: 90% of the time, suitability assessments for this treatment pathway will be completed within 2 business days for exiting inpatients and within 2 weeks for outpatients
The investigators the treatment pathway will be accessible to patients and families. Accessibility is operationalized as timelines of assessment: assessing referrals within 2 business days for existing inpatients and within 2 weeks (10 business days) for current outpatients. This metric will be met 90% of the time.
Measured: From referral to suitability assessment and enrollment, assessed for 2 weeks
Demand: at least 30 youth will consent to being participants in this study
The investigators anticipate sufficient demand for this treatment pathway, operationalized as 30 youth consenting to being participants in this study. Alternatively, at least 30% of approached inpatient youth will consent to being participants in this study.
Measured: From referral to suitability assessment and enrollment, assessed for 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2025
- Study startAug 2025 (estimated)
- Primary completionJul 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Major Depression ModerateStudies 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
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sunnybrook Health Sciences Centre
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Enoch Ng, Sunnybrook Health Sciences Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07140575
- Sponsor's protocol ID
- 6604
- Status last verified
- Aug 2025
- First submitted
- 31 Jul 2025
- Last updated
- 24 Aug 2025
- 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 24 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Seamless Integration of Repetitive Transcranial Magnetic Stimulation (rTMS) for Youth Inpatients With Depression: A Feasibility Study
- ClinicalTrials.gov ID
- NCT07140575
- Acronym / sponsor ID
- 6604
- Conditions
- Major Depression Moderate, Feasibility Studies
- Keywords
- feasibility study, major depressive disorder, adolescent, youth, repetitive transcranial magnetic stimulation, neuromodulation, rTMS, accelerated
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Sunnybrook Health Sciences CentreUniversity, hospital or other
- Study start
- Aug 2025 (estimated)
- Primary completion
- Jul 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 24 Aug 2025 (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.
Youth aged 15-24 are likelier to have depression than all age groups in Canada. One-third of depressed youth do not respond to psychotherapy and/or antidepressant medications. A treatment called repetitive transcranial magnetic stimulation or rTMS has proven helpful in adolescents and young adults whose depressive symptoms have been difficult to treat with psychotherapy and/or antidepressants. Unfortunately, youth find rTMS difficult to access because it is not funded by the Ontario Health Insurance Plan, is typically only offered to adults, and the treatment schedule usually involves once-daily sessions, 5 days/week, for 4-6 weeks, which is associated with travel and opportunity costs e.g. missing school. This project looks at the feasibility of a new treatment pathway that allows youth with difficult-to-treat depression in hospital to receive rTMS twice-daily while engaging in on-unit schooling and therapeutic support. This "accelerated" way of providing rTMS is safe, has equal effectiveness to once-daily rTMS, and can shorten the time needed for treatment. This pathway is for youth already staying in hospital for difficult-to-treat depression or youth outside hospital who have difficult-to-treat depression that interferes with daily function to such a degree that they would benefit from staying in hospital. The investigators anticipate integrating rTMS and inpatient care for youth will be feasible, that it will be acceptable and accessible to youth and families, and there will be sufficient demand for this new treatment pathway. If successful, this project will inform care for youth with difficult-to-treat depression in Ontario and beyond.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| repetitive transcranial magnetic stimulation (rTMS) | Experimental | Device: repetitive transcranial magnetic stimulation (rTMS)twice daily rTMS (intermittent theta burst stimulation targeting the left dorsolateral prefrontal cortex) |
Who may qualify
- Ages
- 14 to 19 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- age 14-19 years
- primary diagnosis of major depressive disorder or of bipolar I or II disorder, current episode depressed with no psychotic or mixed features
- current episode of depression lasting at least 4 weeks
- failed ≥1 evidence-based psychotherapy or antidepressant
- have a GRID-HAMD-17 (17-item Hamilton Depression Rating Scale) score of ≥16 (moderate-severe range)
Key exclusion criteria (9 listed)
- lifetime diagnosis of a psychotic disorder, anorexia nervosa, bulimia nervosa diagnosis of a substance use disorder (except caffeine and tobacco) within the past year
- obsessive compulsive disorder or personality disorder that is the main source and driver of distress
- active psychosis and/or mania
- history of epilepsy or any other neurologic condition that includes a history of seizures
- use of medications that lower the seizure threshold
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 |
|---|---|---|
| repetitive transcranial magnetic stimulation (rTMS)twice daily rTMS, intermittent theta burst stimulation targeting the left dorsolateral prefrontal cortex with a figure-8 coil | Device | repetitive transcranial magnetic stimulation (rTMS) |
Primary outcome
Feasible: 90% of the time, rTMS treatment will be started within 3 business days of a patient consenting during an existing inpatient stay or within 3 business days of the start of an elective inpatient stay
Time frame: From enrollment to start of rTMS treatment, assessed for 8 weeks
The investigators anticipate the treatment path will be feasible, operationalized as the ability to meet the following metric: Starting inpatient rTMS treatment within 3 business days of consenting during an existing inpatient stay or within 3 business days of the start of an elective inpatient stay - this metric will be met 90% of the time
Feasible: 90% completion of weekly Hamilton Depression Rating Scale during treatment by clinician
Time frame: From start of rTMS treatment to end of rTMS treatment, assessed for 4 weeks
The investigators anticipate the treatment path will be feasible, operationalized as the ability to meet the following metric: Completion of the clinician-administered 17-item Hamilton Depression Rating Scale weekly during rTMS treatment with 90% completion rate. The 17-item Hamilton Depression Rating Scale has a minimum score of 0 and maximum score of 52 with higher scores reflecting greater symptom burden.
Acceptable: 25% or lower drop-out rate from completing treatment
Time frame: From enrollment to end of rTMS treatment, assessed for 12 weeks
The investigators anticipate the treatment pathway will be acceptable to patients and families. Acceptability is operationalized as a 25% or lower drop-out rate from completing treatment.
Accessible: 90% of the time, suitability assessments for this treatment pathway will be completed within 2 business days for exiting inpatients and within 2 weeks for outpatients
Time frame: From referral to suitability assessment and enrollment, assessed for 2 weeks
The investigators the treatment pathway will be accessible to patients and families. Accessibility is operationalized as timelines of assessment: assessing referrals within 2 business days for existing inpatients and within 2 weeks (10 business days) for current outpatients. This metric will be met 90% of the time.
Demand: at least 30 youth will consent to being participants in this study
Time frame: From referral to suitability assessment and enrollment, assessed for 2 weeks
The investigators anticipate sufficient demand for this treatment pathway, operationalized as 30 youth consenting to being participants in this study. Alternatively, at least 30% of approached inpatient youth will consent to being participants in this study.
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 24 Aug 2025.
- 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 repetitive transcranial magnetic stimulation (rTMS) in people with Major Depression Moderate and Feasibility Studies, run by Sunnybrook Health Sciences Centre at 1 site in Canada.
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 6 inclusion and 9 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 24 Aug 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 Canada. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasible: 90% of the time, rTMS treatment will be started within 3 business days of a patient consenting during an existing inpatient stay or within 3 business days of the start of an elective inpatient stay (time frame: From enrollment to start of rTMS treatment, assessed for 8 weeks). The study lists 5 primary outcomes in all. 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 24 Aug 2025; AzTrials last refreshed its copy on 26 Oct 2026.