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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests repetitive transcranial magnetic stimulation (rTMS) to determine if it can improve how depressed teens process emotions. Researchers aim to discover whether one session of rTMS can alter brain responses during emotional situations. The trial includes two groups: one receives real rTMS, while the other receives a sham version for comparison. Teens aged 14-21 with major depression who haven't responded to at least one antidepressant may be suitable candidates. As an unphased trial, this study provides a unique opportunity for teens to explore a new treatment option that could potentially enhance emotional processing.

Will I have to stop taking my current medications?

No, you can continue taking your current antidepressant medication as long as it has been stable for at least 4 weeks before the treatment. You should not make any changes or add new psychotropic medications during the study.

What prior data suggests that rTMS is safe for adolescents?

Research has shown that repetitive transcranial magnetic stimulation (rTMS) is generally safe for children and teens with depression. Most side effects, such as headaches, are mild and temporary. Serious risks, including seizures, occur in less than 1% of cases. Overall, rTMS is well-tolerated, making it a promising option for young people dealing with depression. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about rTMS (repetitive Transcranial Magnetic Stimulation) for adolescent depression because it offers a non-invasive alternative to traditional treatments like antidepressant medications and psychotherapy. Unlike these standard treatments, which can take weeks to show effectiveness, rTMS has the potential to produce quicker results by directly stimulating brain regions involved in mood regulation. This method uses magnetic fields to activate nerve cells, which may result in fewer side effects compared to medication. Additionally, rTMS does not require anesthesia or recovery time, making it a promising option for young patients.

What evidence suggests that rTMS might be an effective treatment for adolescent depression?

Research has shown that repetitive transcranial magnetic stimulation (rTMS) might help treat depression in teenagers. In this trial, participants will divide into two groups: one receiving active rTMS and the other receiving sham rTMS. Studies have found that rTMS can safely lessen depression symptoms in young people. One study reported a noticeable drop in depression symptoms after using rTMS. Another study supported rTMS as a promising treatment for teenagers with depression. Overall, rTMS is considered a safe and effective way to manage depression in this age group. ^{1 2 6 7 8}

Are You a Good Fit for This Trial?

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

Hamilton Rating Scale for Depression (17-item) score of at least 20

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

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

Personality disorder deemed to be the primary pathology

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

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/36174786/

A systematic review and preliminary meta-analysis Our findings suggest rTMS could benefit children and adolescents with MDD in a relatively safe manner, and this result may help guide clinical practice.

2. sciencedirect.com sciencedirect.com/science/article/pii/S016517812500215X

Safety and efficacy of Deep TMS for adolescent depression ... The outcomes from iTBS (1800 pulses) and 18 Hz were not significantly different (Fisher's exact test, p>0.05). There was a significant decrease in depression ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6221455/

Transcranial Magnetic Stimulation for Adolescent Depression Transcranial magnetic stimulation (TMS) has increasingly been considered as an investigational treatment for adolescents with depression.

4. clinicaltrials.gov clinicaltrials.gov/study/NCT02611206

Study Details | NCT02611206 | Repetitive Transcranial ... This study will be an open-label 6-week (30 session) trial of active repetitive transcranial magnetic stimulation (rTMS) using a fixed frequency (10 Hz) but ...

5. jaacapopen.org jaacapopen.org/article/S2949-7329(25)00070-5/pdf

The Effectiveness of Transcranial Magnetic Stimulation in ... Objective: To assess the real-world effectiveness of transcranial magnetic stimulation (TMS) for depression in large adolescent and young adult samples.

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40865772/

Efficacy and safety of transcranial magnetic stimulation in ... Our meta-analysis demonstrates that TMS is safe and effective for depressed children and youths, particularly HF-rTMS.

7. clinicaltrials.gov clinicaltrials.gov/study/NCT07185438

Efficacy and Safety of Magnetic Resonance Imaging ... This study aims to assess the feasibility, safety, acceptability, and preliminary efficacy trends of a Magnetic Resonance Imaging-guided ...

8. sciencedirect.com sciencedirect.com/science/article/pii/S0165032723006924

Review Article Efficacy and safety of repetitive transcranial ... rTMS combined with antidepressants enhanced the efficacy of the antidepressant medication. The safety and acceptability of the two groups were comparable.