Recruiting

rTMS

Sponsor:

Sunnybrook Health Sciences Centre

Code:

NCT07140575

Conditions

Major Depression Moderate

Feasibility Studies

Eligibility Criteria

Sex: All

Age: 14 - 19

Healthy Volunteers: Not accepted

Interventions

repetitive transcranial magnetic stimulation (rTMS)

Study Details

Brief 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 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

Study ID

NCT07140575

Start date

Aug, 2025

Status verified date

Aug, 2025

Completion date

Dec, 2027

Anticipated

Primary completion date

Jul, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 14 - 19

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  • 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

Study Design

Enrollment

30 participants

Anticipated

Intervention Model

Single group

Primary purpose

Health Services Research

Interventions and Outcome Measures

Arms

experimental: repetitive transcranial magnetic stimulation (rTMS)

twice daily rTMS (intermittent theta burst stimulation targeting the left dorsolateral prefrontal cortex)

Interventions

repetitive transcranial magnetic stimulation (rTMS)

twice daily rTMS, intermittent theta burst stimulation targeting the left dorsolateral prefrontal cortex with a figure-8 coil

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 ]
  • 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 ]
  • Acceptable: 25% or lower drop-out rate from completing treatment [ Time Frame: 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 [ Time Frame: From referral to suitability assessment and enrollment, assessed for 2 weeks ]
  • 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 ]

Central Contacts and Locations

Locations

Sunnybrook Health Sciences Centre

Recruiting

Toronto, Ontario, Canada, M4N 3M5

Contacts

More Information

Sponsor

Sunnybrook Health Sciences Centre

Last update posted

Aug 24, 2025

Last verified

Aug, 2025

Keywords

  • feasibility study
  • major depressive disorder
  • adolescent
  • youth
  • repetitive transcranial magnetic stimulation
  • neuromodulation
  • rTMS
  • accelerated
  • inpatient

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Sunnybrook Health Sciences Centre on 2025-08-24.