Recruiting

Accelerated vs. Standard

Sponsor:

The Royal Ottawa Mental Health Centre

Code:

NCT06528938

Conditions

Depression

Depressive Disorder, Major

Eligibility Criteria

Sex: All

Age: 16 - 19

Healthy Volunteers: Not accepted

Interventions

Theta Burst Stimulation

Study Details

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

Study ID

NCT06528938

Start date

Aug 1, 2024

Status verified date

Sep, 2025

Completion date

Aug 1, 2026

Anticipated

Primary completion date

Aug 1, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 16 - 19

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

10 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Accelerated iTBS

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).

active comparator: Standard iTBS

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).

Interventions

Theta Burst Stimulation

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

Primary outcome measure

  • Compare the efficacy of accelerated intermittent theta burst stimulation (iTBS) and standard once daily iTBS on clinical response in adolescents. [ 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. ]

Central Contacts and Locations

Central contacts

Locations

The Royal's Institute of Mental Health Research

Recruiting

Ottawa, Ontario, Canada, K1Z 7K4

Contacts

More Information

Sponsor

The Royal Ottawa Mental Health Centre

Last update posted

Sep 9, 2025

Last verified

Sep, 2025

Keywords

  • Accelerated rTMS
  • repetitive Transcranial Magnetic Stimulation

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by The Royal Ottawa Mental Health Centre on 2025-09-09.