rTMS for Adolescent Depression

Overseen By Anusha Baskaran

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: Sunnybrook Health Sciences Centre

Must be taking: Antidepressants

Must not be taking: Anticonvulsants, others

Disqualifiers: Bipolar, Schizophrenia, Seizures, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

30 Participants Needed

Trial Summary

What is the purpose of this trial?

This pilot study aims to examine the feasibility of recruiting depressed adolescents to examine changes in emotional processing and in neural responses to emotional stimuli after one session of rTMS (which is followed by an open-label phase of 4 weeks active rTMS).

Eligibility Criteria

This trial is for boys and girls aged 14-21 with major depression, as defined by the DSM-5. They must have a significant level of depression despite having tried at least one antidepressant treatment, be on a stable medication regimen for 4 weeks prior to the study without changes during it, and be able to follow all study procedures.

Inclusion Criteria

I have tried at least one antidepressant that didn't work for me.

I have been on a stable antidepressant regimen for over 4 weeks and agree not to change it during the study.

Ability to provide informed consent and comply with all testing, follow-ups and study appointments and protocols

Exclusion Criteria

Lifetime diagnosis of bipolar I or II disorder, schizophrenia, schizoaffective disorder, delusional disorder, post-traumatic stress disorder, obsessive compulsive disorder, autism spectrum disorder

I have an active neurological condition.

Alcohol or substance dependence or abuse in the last 6 months, excluding caffeine and nicotine

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Randomized Controlled Phase

Participants undergo one session of either sham or active rTMS followed by emotional processing tasks and fMRI assessment

1 day

1 visit (in-person)

Open-label Treatment Phase

Participants receive active rTMS for 4 weeks

4 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• rTMS

Trial Overview The study tests how rTMS (repetitive Transcranial Magnetic Stimulation), a non-invasive brain stimulation technique, affects emotional processing in depressed adolescents. It starts with one session followed by an open-label phase of active rTMS treatments over four weeks.

Participant Groups

Group I: Active Stimulation Active Control 1 Intervention

15 Depressed adolescents will undergo emotional processing tasks (within and outside the fMRI scanner) after one session of active rTMS

Group II: Sham Stimulation Placebo Group 1 Intervention

15 Depressed adolescents will undergo emotional processing tasks (within and outside the fMRI scanner) after one session of sham rTMS

rTMS is already approved in United States, European Union for the following indications:

Approved in United States as rTMS for:

• Obsessive-Compulsive Disorder (OCD)
• Major Depressive Disorder
• Migraines
• Smoking cessation

Approved in European Union as rTMS for:

• Obsessive-Compulsive Disorder (OCD)
• Major Depressive Disorder

Who Is Running the Clinical Trial?

Sunnybrook Health Sciences Centre

Lead Sponsor

Trials

693

Recruited

1,569,000+