rTMS for Youth Inpatients With Depression
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age14-19
SponsorSunnybrook Health Sciences Centre
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Single group
Treatments tested in this trial
repetitive transcranial magnetic stimulation (rTMS)
Devicetwice daily rTMS, intermittent theta burst stimulation targeting the left dorsolateral prefrontal cortex with a figure-8 coil
Treatment groups
30 Participants
are divided into 1 treatment groupGroup A: repetitive transcranial magnetic stimulation (rTMS)Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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
Time frame
From enrollment to start of rTMS treatment, assessed for 8 weeks2
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.
Time frame
From start of rTMS treatment to end of rTMS treatment, assessed for 4 weeks3
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.
Time frame
From enrollment to end of rTMS treatment, assessed for 12 weeks4
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.
Time frame
From referral to suitability assessment and enrollment, assessed for 2 weeksSponsors and contacts
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Source ClinicalTrials.gov