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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
Theta Burst Stimulation
DeviceCool B70 coil (left DLPFC) with X100 MagPro rTMS Device (Magventure A/S, Farum, Denmark)
Treatment groups
10 Participants
are divided into 2 treatment groupsGroup A: Accelerated iTBSActive comparator 1 intervention
Group B: Standard iTBSActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Compare the efficacy of accelerated intermittent theta burst stimulation (iTBS) and standard once daily iTBS on clinical response in adolescents.
Clinical response will be defined as a ≥ 50% reduction in depressive symptoms based on the Children's Depression Rating Scale Revised for depression (CDRS-R). The CDRS-R is a clinician-evaluated instrument consisting of 17 items used to measure the severity of depressive episodes in a pediatric population in children 6 to 12 years of age that has been shown to be applicable in adolescents as well. The overall score ranges from 17 to 113, where scores of ≥40 suggest moderate to severe depression and ≤28 is defined as remission or asymptomatic. In this study, a response to treatment will be defined as a reduction of 50% or more on the overall CDRS-R score at the post-intervention assessment (post-treatment 30).
Time frame
Administered at screening, weekly for 2 weeks in accelerated group, every 3rd week for 6 weeks in once/daily (standard) group, as well as 2-, 4- and 12-weeks post-treatment course for both treatment protocols.Secondary outcomes
1
Change in self-reported suicidal ideation as measured by Beck Scale for Suicidal Ideation (BSS).
The BSS is a self-administered questionnaire consisting of 19 items that assesses an individual's presence of suicidal ideations and intensity. Each item is rated on a scale of 0 to 2, with a possible total score ranging from 0 to 38. Several other questionnaires addressing anxiety, sleep quality, physical activity and stress, among others, will be administered.
Time frame
Administered at screening, every other day for 2 weeks in accelerated group, weekly for 6 weeks in once/daily (standard) group, as well as 2-, 4- and 12-weeks post-treatment course for both treatment protocols.Sponsors and contacts
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The Royal Ottawa Mental Health Centre
Lead sponsor
Université de Sherbrooke
Collaborator
Source ClinicalTrials.gov