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

NCT06528938 | Recruiting

• 1 other identifier: 0047
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Depression; Depressive Disorder, Major

Keywords

Accelerated rTMS; repetitive Transcranial Magnetic Stimulation

Outcome Measures

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).

  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).

  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.

Study Arms (2)

Accelerated iTBS

ACTIVE COMPARATOR

Intermittent Theta Burst Stimulation (iTBS) will be applied to the left dorsolateral prefrontal cortex (DLPFC). Participants will receive daily sessions (Mon-Fri), three times a day for 10 days (2 weeks).

Device: Theta Burst Stimulation

Standard iTBS

ACTIVE COMPARATOR

Intermittent Theta Burst Stimulation (iTBS) will be applied to the left DLPFC. Participants will receive daily sessions (Mon-Fri), once a day for 30 days (6 weeks).

Device: Theta Burst Stimulation

Interventions

Theta Burst Stimulation DEVICE

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

Accelerated iTBS; Standard iTBS

Eligibility Criteria

• Age: 16 Years - 19 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• Diagnosis of bipolar I or II disorder, based on the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) criteria.
• 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.

Sponsors & Collaborators

• The Royal Ottawa Mental Health Centre: lead
• Université de Sherbrooke: collaborator

Study Sites (1)

The Royal's Institute of Mental Health Research

Ottawa, Ontario, K1Z 7K4, Canada

RECRUITING

MeSH Terms

Conditions

Depression; Depressive Disorder, Major

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Depressive Disorder; Mood Disorders; Mental Disorders

Study Officials

• Sara Tremblay, PhD

  The Royal's Institute of Mental Health Research

  PRINCIPAL INVESTIGATOR

• Jean-François Lepage, PhD

  Sherbrooke University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Stacey Shim, MSc

CONTACT

613-722-6521; stacey.shim@theroyal.ca

Maya El-Outa, BSc

CONTACT

613-722-6521; Maya.El-Outa@theroyal.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 14, 2024
• First Posted: July 30, 2024
• Study Start: August 1, 2024
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): August 1, 2026
• Last Updated: September 9, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: SAP
• Time Frame: De-identified data may become available (upon request) when the study is completed and published (anticipated time frame: the year of 2026)
• Access Criteria: De-identified data will be accessible only through the permission of the lead research scientist. All requests must be made and accepted by her.

Locations

CA (1)