Comparing the Efficacy of Accelerated vs. Standard fMRI-guided iTBS in Treating Adolescents Depression
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age16-19
SponsorThe Royal Ottawa Mental Health Centre
About this trial
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 major depression in adults and adolescents. However, very few studies have assessed the efficacy of accelerated, three times a day TBS in comparison with standard once a day TBS in adolescents. The study aims to explore further evidence in hopes to conduct a large-scale, randomized, multisite, placebo-controlled clinical trial evaluating the effects of a functional magnetic resonance imaging (fMRI)-guided accelerated rTMS protocol vs. standard once/daily rTMS for treatment-resistant depression in adolescents.
Eligibility criteria
Qualifiers
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).
Disqualifiers
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).
Trial design
Treatments tested in this trial
- Theta Burst Stimulation
Treatment groups
10 Participants
are divided into 2 treatment groupsSponsors and collaborators
The Royal Ottawa Mental Health Centre
Lead sponsor
Université de Sherbrooke
Collaborator
Source ClinicalTrials.gov