Accelerated TMS for Major Depressive Disorder

Overseen By Saydra Wilson, MD

Age: 18+

Sex: Any

Trial Phase: Phase < 1

Sponsor: University of Minnesota

Must be taking: Antidepressants

Must not be taking: Benzodiazepines

Disqualifiers: Bipolar, Psychosis, Mania, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 6 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests Accelerated Transcranial Magnetic Stimulation (aTMS) to determine if it can treat Major Depressive Disorder more quickly and conveniently than traditional methods. The researchers aim to assess the effectiveness of aTMS when delivered on a faster schedule, potentially allowing patients to spend less time in treatment and more time on daily activities. This study may suit adults with unipolar depression who are patients at the St. Louis Park clinic and have tried at least one antidepressant. As an Early Phase 1 trial, this research focuses on understanding how aTMS works in people, offering participants the opportunity to be among the first to experience this innovative treatment approach.

Do I have to stop taking my current medications for the trial?

You need to keep your current medications stable during the study, so you won't have to stop taking them.

What prior data suggests that this method is safe for patients with major depressive disorder?

Research has shown that accelerated Transcranial Magnetic Stimulation (aTMS) is generally safe and well-tolerated. One study found that aTMS improved symptoms by 33% after just one week, with improvement increasing to 43% after four weeks. No major safety issues were reported. Another study examined aTMS for both obsessive-compulsive disorder and major depressive disorder, finding it safe and tolerable.

TMS is a non-invasive treatment that uses magnetic fields to stimulate brain cells, potentially offering quick relief from depression symptoms without major side effects. While these results are promising, it is important to note that this accelerated form of aTMS is still being studied in early trials, so more research is needed to confirm its safety for everyone. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Accelerated Transcranial Magnetic Stimulation (aTMS) is unique because it offers a faster approach to treating major depressive disorder compared to standard treatments like antidepressants and traditional TMS. Most treatments for depression can take weeks to show results, but aTMS has the potential to deliver improvements in just a few days. Researchers are excited about this treatment because it uses high-frequency magnetic pulses to stimulate brain areas involved in mood regulation, potentially providing a quicker and more efficient alternative for patients who need rapid relief from depressive symptoms.

What evidence suggests that Accelerated Transcranial Magnetic Stimulation (aTMS) might be an effective treatment for Major Depressive Disorder?

Research has shown that Accelerated Transcranial Magnetic Stimulation (aTMS), the treatment under study in this trial, could be a promising option for Major Depressive Disorder. Studies have found that aTMS is safe and generally well-tolerated, with 33% of participants responding positively after one week and 43% after four weeks. Another study suggested that aTMS works faster and more effectively than standard repetitive TMS, improving depression symptoms more quickly. These findings indicate it could provide faster relief from depression symptoms, making it a potentially better option for patients. ^{1 3 5 6 7}

Are You a Good Fit for This Trial?

This trial is for current patients of the SLP Clinic with a diagnosis of Unipolar Depression who have tried at least one antidepressant and can keep their medication stable during the study. It's not suitable for those who don't meet these criteria.

Inclusion Criteria

I am currently seeing a doctor at the SLP Clinic.

I can keep my medication routine the same throughout the study.

I have tried at least one antidepressant.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Focus Group

Focus group to collect opinions and feedback about implementation of aTMS among clinical staff

1 week

Questionnaire Delivery

Delivery of a set of questionnaires to TMS patients awaiting the start of their TMS series

1 week

Treatment

Delivery of Accelerated Transcranial Magnetic Stimulation (aTMS) using the MagVenture TMS device

6 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Accelerated Transcranial Magnetic Stimulation (aTMS)

Trial Overview The FAST-MDD trial is testing an accelerated form of Transcranial Magnetic Stimulation (aTMS) using the MagVenture TMS device to see if it's effective and acceptable when given on an expedited schedule compared to traditional daily sessions.

How Is the Trial Designed?

Group I: Study group Experimental Treatment 1 Intervention

Patients with major depressive disorder

Who Is Running the Clinical Trial?

University of Minnesota

Lead Sponsor

Trials

1,459

Recruited

1,623,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12090592/

Accelerated repetitive transcranial magnetic stimulation in ... Results indicated that accelerated rTMS is well-tolerated and safe, leading to a 33% response rate at week 1 and an increase to 43% at week 4 [ ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S3050529125000935

Accelerated repetitive Transcranial Magnetic Stimulation ... Treatment with aTMS seems faster and more effective than treatment with standard rTMS in improving the clinical condition in patients with Major Depressive ...

3. bmcpsychiatry.biomedcentral.com bmcpsychiatry.biomedcentral.com/articles/10.1186/s12888-024-05545-1

Short-term and long-term efficacy of accelerated transcranial ... Conclusion. In summary, aTMS improved depressive symptoms in patients with MDD more rapidly than did standard TMS. Although there seems to be ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT06783361

Accelerated Transcranial Magnetic Stimulation in ... Patients diagnosed with Major Depressive Disorder according to DSM 5 and the severity of their illness; Scoring 7 points or more on the Maudsley staging method ...

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. sciencedirect.com sciencedirect.com/science/article/pii/S3050529125000984

Safety and tolerability of dual-site accelerated transcranial ... Safety and tolerability of dual-site accelerated transcranial magnetic stimulation treatment for obsessive-compulsive disorder and major depressive disorder.

7. brainstimjrnl.com brainstimjrnl.com/article/S1935-861X(24)00124-4/fulltext

A pilot study of safety and efficacy using a pragmatic protocol Accelerated transcranial magnetic stimulation: A pilot study of safety and efficacy using a pragmatic protocol. John G. Luehr. John G.