Accelerated TMS for Depression

Recruiting at 2 trial locations

Overseen By Neha Goyal

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: Neuronetics

Must be taking: Antidepressants

Disqualifiers: Substance use disorder, Schizophrenia, others

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

Compensation: Varies

Number of Visits: 5

Duration: 1 week

50 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a treatment called accelerated TMS, which stands for transcranial magnetic stimulation, to determine its effectiveness for Major Depressive Disorder (MDD). The researchers aim to find out if receiving several TMS treatments rapidly over a few days can effectively improve depression symptoms. Individuals with MDD who are currently experiencing a depressive episode and have not found relief from at least one antidepressant might be suitable candidates. Participants must be on a stable treatment plan and willing to complete all study visits and assessments. As an unphased trial, this study provides a unique opportunity to explore a potentially effective treatment for depression symptoms.

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

No, you don't have to stop taking your current medications. Participants need to be on a stable antidepressant treatment regimen for at least the past 4 weeks and agree to stay on the same treatment throughout the study.

What prior data suggests that accelerated TMS is safe for treating Major Depressive Disorder?

Research has shown that accelerated transcranial magnetic stimulation (TMS) is generally safe and well-tolerated. Some studies have found that accelerated TMS can help reduce symptoms of depression. For instance, one study noted that 33% of participants responded positively by the end of the first week, increasing to 43% by the fourth week. Another study showed that accelerated TMS significantly reduced depression symptoms compared to a fake treatment.

Additionally, the safety of accelerated TMS aligns with standard TMS treatments for depression approved by the FDA. The side effects of accelerated TMS resemble those of traditional TMS, which are usually mild and may include headaches or scalp discomfort. Overall, these studies suggest that accelerated TMS is a safe treatment option for people with major depressive disorder. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Accelerated TMS is unique because it delivers multiple sessions of transcranial magnetic stimulation (TMS) for depression in a short period, unlike traditional TMS, which typically involves fewer sessions spread out over several weeks. This accelerated approach means patients may experience relief much quicker. Researchers are excited about this treatment because it has the potential to significantly reduce the time it takes for patients to feel better, offering a faster alternative for those suffering from depression.

What evidence suggests that accelerated TMS is effective for Major Depressive Disorder?

Research has shown that accelerated TMS (transcranial magnetic stimulation), the treatment under study in this trial, effectively treats major depressive disorder (MDD). One study demonstrated a 33% improvement in symptoms after just one week, increasing to 43% by the fourth week. Another study found significant reductions in depression scores with accelerated TMS. This treatment has also reduced symptoms of both depression and OCD more effectively than a placebo. Overall, accelerated TMS can quickly ease depression symptoms, making it a promising fast-acting treatment option. ^{1 2 3 5 6}

Who Is on the Research Team?

Eleanor Cole, PhD

Principal Investigator

Neuronetics

Are You a Good Fit for This Trial?

This trial is for adults and adolescents aged 15+ with Major Depressive Disorder (MDD). Adults must have tried at least one antidepressant without success. Adolescents can use TMS as an additional treatment even if they haven't tried other medications. Participants should be on a stable antidepressant regimen for 4 weeks prior to the study.

Inclusion Criteria

I am either male or female.

I am an adult who didn't improve with at least one antidepressant, or I am a teenager for whom TMS is an additional treatment.

I am 15 years old or older.

Exclusion Criteria

Participants satisfy any one or more of the contraindications for TMS per current treatment guidelines as determined by the PI

Total MADRS score of < 20 or PHQ-score <10 at the screen or baseline visits

I have a condition more severe than my depression in the last 6 months.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive accelerated TMS treatment with 36 sessions over 5 consecutive days

1 week

5 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

2 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Accelerated TMS

Trial Overview

The study is testing accelerated Transcranial Magnetic Stimulation (TMS) therapy in patients with MDD to see how well it works and if it's feasible. It's an open-label, multi-center trial, meaning both researchers and participants know what treatment is being given.

How Is the Trial Designed?

Group I: Treatment Arm Experimental Treatment 1 Intervention

Patients will receive 5 consecutive calendar days of treatments with 6-8 treatments per day for a total of 36 treatments

Who Is Running the Clinical Trial?

Neuronetics

Lead Sponsor

Trials

25

Recruited

15,300+

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.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/38326789/

Short-term and long-term efficacy of accelerated ...

The findings showed that depression scores significantly decreased following the intervention (SMD = 1.80, 95% CI (1.31, 2.30), p < 0.00001).

3.

sciencedirect.com

sciencedirect.com/science/article/pii/S1876201825000632

Efficacy and safety of accelerated transcranial magnetic ...

Accelerated TMS significantly reduced OCD and depressive symptoms, and increased response rate compared to sham aTMS.

4.

nature.com

nature.com/articles/s41386-023-01599-z

Accelerated TMS - moving quickly into the future of ...

Overall, accelerated TMS appears to hold promise to reduce treatment time and achieve rapid reduction in depressive symptoms, but at this time ...

5.

clinicaltrials.gov

clinicaltrials.gov/study/NCT06783361

Accelerated Transcranial Magnetic Stimulation in ...

In addition, the study aims to evaluate whether there will be a decrease in the severity of depression after TMS treatment and whether there is any change in ...

6.

bmcpsychiatry.biomedcentral.com

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

Short-term and long-term efficacy of accelerated transcranial ...

In recent years, researchers have proposed multiple daily TMS sessions to rapidly improve depressive symptoms. Accelerated transcranial magnetic ...