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RECRUITING

NCT06528938

Comparing the Efficacy of Accelerated vs. Standard fMRI-guided iTBS in Treating Adolescents Depression

Sponsor: The Royal Ottawa Mental Health Centre

View on ClinicalTrials.gov

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.

Official title: Randomized Pilot Trial Comparing the Feasibility and Efficacy of Accelerated vs. Standard fMRI-guided iTBS in Treatment-Resistant Depression in Adolescents

Key Details

Gender

All

Age Range

16 Years - 19 Years

Study Type

INTERVENTIONAL

Enrollment

Start Date

2024-08-01

Completion Date

2026-08-01

Last Updated

2025-09-09

Healthy Volunteers

Conditions

Depression Depressive Disorder, Major

Interventions

DEVICE

Theta Burst Stimulation

Cool B70 coil (left DLPFC) with X100 MagPro rTMS Device (Magventure A/S, Farum, Denmark)

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) (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. 3. Current use of illegal substances or cannabis confirmed by urine screening test. 4. Concomitant unstable major medical or neurological disease (e.g., uncontrolled diabetes or renal dysfunction). 5. Organic cause of depressive symptoms (e.g. thyroid dysfunction), ruled out by the treating physician. 6. Acute suicidality or life-threatening due to self-neglect. 7. Are pregnant or breastfeeding, or plan to become pregnant during treatment (pregnancy will be assessed by a urine test). 8. Have a specific contraindication to TMS and/or MRI (e.g., personal history of epilepsy or seizures, metal head implant, pacemaker). 9. Unwilling to maintain the current antidepressant regimen. 10. Taking more than 1 mg/day of lorazepam or equivalent. 11. Any other condition that, in the opinion of the investigators, would impair the participant's ability to complete the study.

Locations (1)

The Royal's Institute of Mental Health Research

Ottawa, Ontario, Canada