rTMS for Depression

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: Sunnybrook Health Sciences Centre

Must not be taking: Seizure threshold-lowering drugs

Disqualifiers: Psychotic disorder, Anorexia, Bulimia, others

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

Compensation: Varies

Number of Visits: 1

Duration: 4-6 weeks

30 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a faster method of using repetitive transcranial magnetic stimulation (rTMS) for young people with depression unresponsive to therapy or medication. rTMS uses magnetic fields to stimulate brain areas linked to mood. The researchers aim to make the treatment more accessible and effective by offering it twice daily to those already in the hospital or who might benefit from hospital care. Teens aged 14-19 with depression that hasn't improved with past treatments might be suitable for this trial. As an unphased trial, this study provides a unique opportunity for participants to contribute to innovative research that could enhance future treatment options.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but it excludes those using medications that lower the seizure threshold. It's best to discuss your specific medications with the trial team.

What prior data suggests that this accelerated rTMS treatment pathway is safe for youth with difficult-to-treat depression?

Research has shown that repetitive transcranial magnetic stimulation (rTMS) is generally well-tolerated by people with major depression. Studies have found that side effects are usually mild, such as headaches or scalp discomfort, and these often resolve on their own. Available research has reported no serious problems directly caused by rTMS.

Patients have responded positively to rTMS when traditional treatments like therapy or medication do not work. Real-world data shows that 40–50% of people with major depression notice an improvement in their symptoms.

While rTMS is not yet widely available for young people, it is an FDA-approved treatment for adults with depression. This approval indicates a strong safety record based on current evidence. However, as with any treatment, individual experiences can vary. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Repetitive transcranial magnetic stimulation (rTMS) is unique because it uses magnetic fields to stimulate nerve cells in the brain, particularly targeting the left dorsolateral prefrontal cortex, which is linked to mood regulation. This non-invasive technique offers a different approach compared to standard treatments for depression, like antidepressants and psychotherapy. Researchers are excited about rTMS because it has the potential to provide quicker relief with fewer side effects and can be an option for those who haven't found success with traditional therapies.

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

Research has shown that repetitive transcranial magnetic stimulation (rTMS), which participants in this trial will receive, can effectively treat depression, even when other treatments fail. Studies indicate that about 40-50% of people with major depressive disorder respond well to rTMS. For those with treatment-resistant depression, up to 42.8% experience complete relief from symptoms. This treatment uses magnetic fields to target specific areas of the brain, helping to improve mood. Overall, rTMS offers a promising option for those who haven't found relief from other depression treatments. ^{1 4 6 7 8}

Are You a Good Fit for This Trial?

This trial is for youth aged 15-24 in Canada with difficult-to-treat depression, who haven't had success with psychotherapy and/or antidepressants. It's aimed at those already hospitalized or those whose daily function is severely impacted by depression. The study tests an 'accelerated' rTMS treatment that could be more accessible and fit into the patients' schedules better.

Inclusion Criteria

I have been feeling depressed for at least 4 weeks.

I am between 14 and 19 years old.

I have tried at least one therapy or antidepressant without success.

Exclusion Criteria

Pregnancy or nursing

Inability to adhere to the protocol

My depression symptoms improved by 25% or more recently.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2 weeks

1 visit (in-person)

Treatment

Participants receive twice-daily rTMS sessions while engaging in on-unit schooling and therapeutic support

4-6 weeks

Daily sessions (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Weekly assessments (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• rTMS

Trial Overview The trial investigates the feasibility of a new treatment pathway using accelerated repetitive transcranial magnetic stimulation (rTMS). This involves twice-daily sessions combined with on-unit schooling and therapeutic support for hospitalized youth, aiming to reduce treatment time while maintaining safety and effectiveness.

How Is the Trial Designed?

Group I: repetitive transcranial magnetic stimulation (rTMS) Experimental Treatment 1 Intervention

twice daily rTMS (intermittent theta burst stimulation targeting the left dorsolateral prefrontal cortex)

Who Is Running the Clinical Trial?

Sunnybrook Health Sciences Centre

Lead Sponsor

Trials

693

Recruited

1,569,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10375664/

Efficacy of repetitive transcranial magnetic stimulation ... Data on remission rates were available from 9 studies. The overall remission rate was 35.71% (120/336) in the active rTMS group and 8.37% (18/ ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8474312/

Repetitive transcranial magnetic stimulation for major ... Real world data has also confirmed the effectiveness of rTMS for MDD in clinical practice, with the most recent literature indicating response rates of 40–50% ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S0165178124005481

A multisite observational real-world study on the ... Efficacy of rTMS for treatment-resistant depression was confirmed by multisite data. HAMD-17 showed 53.5 % response and 42.8 % remission rates after rTMS ...

4. thelancet.com thelancet.com/journals/eclinm/article/PIIS2589-5370(24)00339-0/fulltext

Antidepressant class and concurrent rTMS outcomes in ... Previous meta-analyses reported that antidepressants commenced with rTMS demonstrated greater efficacy than antidepressants with sham rTMS.

5. sciencedirect.com sciencedirect.com/science/article/pii/S0165032720325933

Clinical outcomes in a large registry of patients with major ... Randomized clinical trials have demonstrated that Transcranial Magnetic Stimulation (TMS) is an effective treatment for episodes of major depressive disorder ( ...

6. sciencedirect.com sciencedirect.com/science/article/pii/S0272735822001210

Efficacy and safety of transcranial magnetic stimulation for ... Our results suggest the effects and safety of TMS in treating MDD are likely lower in some populations than previous estimates suggested. •. Future research ...

7. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2835319

Repetitive Transcranial Magnetic Stimulation as ... The relapse prevention success rate at 24 weeks in the rTMS monotherapy group was approximately 85%, whereas prior literature indicates that the ...

8. mayoclinic.org mayoclinic.org/tests-procedures/transcranial-magnetic-stimulation/about/pac-20384625

Transcranial magnetic stimulation Results. If rTMS works for you, your depression symptoms may improve or go away completely. Symptom relief may take a few weeks of treatment.