NCT06528938 Comparing the Efficacy of Accelerated vs. Standard fMRI-guided iTBS in Treating Adolescents Depression
| NCT ID | NCT06528938 |
| Status | Recruiting |
| Phase | — |
| Sponsor | The Royal Ottawa Mental Health Centre |
| Condition | Depression |
| Study Type | INTERVENTIONAL |
| Enrollment | 10 participants |
| Start Date | 2024-08-01 |
| Primary Completion | 2026-08-01 |
Trial Parameters
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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 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
Inclusion Criteria: 1. Voluntary and competent to consent. 2. Ages 16-19 years old. 3. Can speak and read English. 4. 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). 5. Depressive symptoms have not improved after ≥ 1 adequate dose of antidepressant in the current depressive episode. 6. 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). 7. Are able to adhere to the treatment schedule. 8. Have stable psychotropic medications and/or psychotherapy regimen for at least four weeks before participating in the trial. Exclusion Criteria: 1. Diagnosis of bipolar I or II disorder, based on the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) criteria. 2. Current or past substance (\< 3 months)
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