Status:
RECRUITING
Comparing the Efficacy of Accelerated vs. Standard fMRI-guided iTBS in Treating Adolescents Depression
Lead Sponsor:
The Royal Ottawa Mental Health Centre
Collaborating Sponsors:
Université de Sherbrooke
Conditions:
Depression
Depressive Disorder, Major
Eligibility:
All Genders
16-19 years
Phase:
NA
Brief Summary
Repetitive transcranial magnetic stimulation (rTMS) is a Health Canada approved treatment for major depression. Theta burst stimulation (TBS), a type of rTMS, is a very promising new treatment for maj...
Detailed Description
Recently the efficacy of repetitive Transcranial Magnetic Stimulation (rTMS) has significantly improved for Treatment-Resistant Depression (TRD) in adults and promising evidence suggesting safety and ...
Eligibility Criteria
Inclusion
- Voluntary and competent to consent.
- Ages 16-19 years old.
- Can speak and read English.
- Primary and/or predominant diagnosis of major depressive episode without psychotic features in the current episode, confirmed by The Mini International Neuropsychiatric Interview for Children and Adolescents (MINI-KID).
- Depressive symptoms have not improved after ≥ 1 adequate dose of antidepressant in the current depressive episode.
- Moderate symptoms in the current depressive episode, indexed by a score of at least 40 on the Children's Depression Rating Scale Revised for depression (CDRS-R).
- Are able to adhere to the treatment schedule.
- Have stable psychotropic medications and/or psychotherapy regimen for at least four weeks before participating in the trial.
Exclusion
- Diagnosis of bipolar I or II disorder, based on the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) criteria.
- Current or past substance (\< 3 months) (excluding caffeine or nicotine) or alcohol abuse/dependence, as defined in the DSM-5 criteria. Based on DSM-5 criteria, mild cannabis or alcohol use would be allowed in the past 3 months, moderate to severe would be an exclusion.
- Current use of illegal substances or cannabis confirmed by urine screening test.
- Concomitant unstable major medical or neurological disease (e.g., uncontrolled diabetes or renal dysfunction).
- Organic cause of depressive symptoms (e.g. thyroid dysfunction), ruled out by the treating physician.
- Acute suicidality or life-threatening due to self-neglect.
- Are pregnant or breastfeeding, or plan to become pregnant during treatment (pregnancy will be assessed by a urine test).
- Have a specific contraindication to TMS and/or MRI (e.g., personal history of epilepsy or seizures, metal head implant, pacemaker).
- Unwilling to maintain the current antidepressant regimen.
- Taking more than 1 mg/day of lorazepam or equivalent.
- Any other condition that, in the opinion of the investigators, would impair the participant's ability to complete the study.
Key Trial Info
Start Date :
August 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2026
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT06528938
Start Date
August 1 2024
End Date
August 1 2026
Last Update
September 9 2025
Active Locations (1)
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1
The Royal's Institute of Mental Health Research
Ottawa, Ontario, Canada, K1Z 7K4