Comparing two methods of brain stimulation for treating depression in adolescents

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

This study is testing if a faster way of brain stimulation can help teenagers with hard-to-treat depression feel better compared to the standard method.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 10 (estimated)
• Ages: 16 Years to 19 Years
• Sex: All
• Sponsor: The Royal Ottawa Mental Health Centre (Academic / other)
• Locations: 1 site (Ottawa, Ontario)
• Trial ID: NCT06528938 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to compare the efficacy of accelerated intermittent theta burst stimulation (iTBS) versus standard once-a-day iTBS in adolescents diagnosed with major depressive disorder. The study will recruit 10 adolescents aged 16-19 who have treatment-resistant depression and will assess their symptoms through clinical evaluations and self-report questionnaires. Participants will undergo an MRI scan before receiving either treatment for a duration of 6 weeks, with the accelerated group receiving treatment three times a day for 2 weeks. The goal is to gather evidence to support larger-scale trials for this promising treatment approach.

Who should consider this trial

Good fit: Ideal candidates for this study are adolescents aged 16-19 with major depressive disorder who have not responded to previous antidepressant treatments.

Not a fit: Patients with bipolar disorder or those who have not been stable on their psychotropic medications for at least four weeks may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a more effective treatment option for adolescents suffering from treatment-resistant depression.

How similar studies have performed: While there is promising evidence for the efficacy of rTMS in adolescents, this specific comparison of accelerated versus standard iTBS is novel and has not been extensively tested.

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) (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.

Where this trial is running

Ottawa, Ontario

• The Royal's Institute of Mental Health Research — Ottawa, Ontario, Canada (Recruiting)

Study contacts

• Principal investigator: Sara Tremblay, PhD — The Royal's Institute of Mental Health Research
• Study coordinator: Stacey Shim, MSc

Conditions Depression; Depressive Disorder, Major; Accelerated rTMS; repetitive Transcranial Magnetic Stimulation