rTMS for Youth Inpatients With Depression
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: repetitive transcranial magnetic stimulation (rTMS).
- Who it may be relevant to
- Registry conditions: Major Depression Moderate, Feasibility Studies. Basic parameters: 14 years — 19 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Canada
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Seamless Integration of Repetitive Transcranial Magnetic Stimulation (rTMS) for Youth Inpatients With Depression: A Feasibility Study
Overview
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.
Interventions
- Device 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 measures
- 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]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Health services research
Study locations
Canada · 1 center
- Sunnybrook Health Sciences Centre — Toronto
Identifiers
NCT: NCT07140575 · 6604