Intermittent Theta Burst Stimulation for Depression

MK
Overseen ByManpreet K Singh, MD, MS
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: University of California, Davis
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new method called accelerated intermittent theta burst stimulation (iTBS), which uses magnetic fields to boost brain activity, to determine its effectiveness in reducing depression symptoms. Participants will receive either the real iTBS treatment or a placebo, and researchers will compare the outcomes. They will also examine changes in brain and body markers, as well as emotions, to see if these correlate with treatment effectiveness. The study seeks English-speaking adults diagnosed with major depression who are not currently using certain medications or substances. As an unphased trial, it offers participants the chance to contribute to groundbreaking research that could lead to new treatment options for depression.

Will I have to stop taking my current medications?

You may need to stop taking certain medications, like benzodiazepines, that could interfere with the TMS treatment. It's best to discuss your current medications with the study team to see if any changes are needed.

What prior data suggests that intermittent theta burst stimulation is safe for treating depression?

Research has shown that intermittent theta burst stimulation (iTBS) is generally safe for treating depression. Studies have found that most people tolerate iTBS well. For example, a recent analysis demonstrated that real iTBS outperformed placebo treatments in improving depression symptoms, without major safety concerns.

In another study involving teenagers, iTBS proved safe and effective, though its benefits diminished over time, indicating the potential need for repeated sessions to maintain effects. Another report found that side effects were similar to those of other treatments, with most participants not experiencing serious issues.

Overall, evidence suggests iTBS is a safe option for many people with depression, making it a promising non-invasive treatment.12345

Why are researchers excited about this trial?

Intermittent Theta Burst Stimulation (iTBS) is unique because it offers a non-invasive, rapid treatment option for depression, setting it apart from standard treatments like antidepressants and psychotherapy. Unlike medications that can take weeks to show effects, iTBS has the potential to provide noticeable improvement within days by using brief, high-frequency bursts of magnetic pulses to stimulate brain activity. Researchers are excited about iTBS because it targets specific brain areas linked to mood regulation, potentially leading to faster and more targeted relief for patients with depression.

What evidence suggests that intermittent theta burst stimulation is effective for depression?

Research has shown that intermittent theta burst stimulation (iTBS), a treatment available in this trial, can reduce symptoms of major depressive disorder (MDD). Studies indicate that iTBS helps 30% to 60% of people feel better, with 10% to 40% experiencing complete relief from symptoms. Specifically, one study found that about 69% of patients improved with iTBS, and nearly half saw their symptoms disappear entirely within four weeks. iTBS is also considered safe and effective for individuals who haven't found success with other depression treatments. It uses magnetic fields to stimulate specific brain areas, potentially improving mood and reducing depression symptoms.34678

Are You a Good Fit for This Trial?

This trial is for English-speaking adults aged 18-65 who have been diagnosed with major depression. People can't join if they have active substance abuse, untreated psychosis, certain medications or medical conditions that interfere with TMS or MRI, are pregnant or breastfeeding, or recently participated in another clinical study.

Inclusion Criteria

English speaking
Able to provide informed consent
I am between 18 and 65 years old.
See 1 more

Exclusion Criteria

Active substance use or severe substance use that in the opinion of the PI would interfere with study participation
I am unable to give consent because of my medical or mental condition.
I am not taking medications that could interfere with TMS treatment.
See 4 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive 10 stimulation sessions per day for 5 consecutive days, totaling 50 sessions of either active iTBS or sham stimulation. MRI brain scans, EEG recordings, and biological samples are collected.

1 week
5 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment with follow-up visits at 1 week, and at 1, 3, 6, and 12 months. Depression rating scales and questionnaires are completed, and facial and vocal samples are recorded.

12 months
5 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

  • Intermittent Theta Burst Stimulation
  • Sham (No Treatment)

Trial Overview

The study compares a rapid brain stimulation treatment called intermittent theta burst stimulation (iTBS) to a sham (placebo) procedure over five days. Participants are randomly assigned and receive multiple sessions daily to see if iTBS helps reduce depression symptoms.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Placebo Group

Group I: Active iTBSExperimental Treatment1 Intervention
Group II: Sham iTBSPlacebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of California, Davis

Lead Sponsor

Trials
958
Recruited
4,816,000+

Citations

Intermittent Theta Burst Stimulation for Major Depressive ...

The response rate ranged between 30 and 60%, and the remission rate between 10 and 40%. Regarding comparative findings, the results are mixed, ...

2.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/41967364/

Effectiveness of intermittent theta-burst stimulation for ...

iTBS is effective for MDD in routine clinical practice; however, its therapeutic impact appears moderately reduced in patients with ASD ...

Effectiveness of intermittent theta-burst stimulation for ...

Conclusions. iTBS is effective for MDD in routine clinical practice; however, its therapeutic impact appears moderately reduced in patients with ASD and/or ADHD ...

Efficacy and safety of intermittent theta-burst stimulation ...

In patients with MDD, daily iTBS outperformed daily cTBS in terms of antidepressant efficacy, with comparable safety and tolerability profiles ( ...

NCT07033780 | Theta-Burst Stimulation to Treat Depression

It has been demonstrated to induce sustained plasticity in the DLPFC and the motor cortex. Studies have shown that iTBS is equally effective as ...

Efficacy and safety of intermittent theta-burst stimulation ... - PMC

A recent network meta-analysis (24) showed a significant superiority of active over sham iTBS in improving depressive symptoms in depression, ...

Efficacy and Safety of Accelerated Intermittent Theta Burst ...

a-iTBS was a safe and effective treatment for adolescents with non–treatment-resistant MDD, but the therapeutic effect diminished at the 3-month ...

Efficacy and safety of intermittent theta burst stimulation ...

The objective of this systematic review was to compare the safety and efficacy of iTBS and high-frequency (≥ 5 Hz) rTMS (HF-rTMS) for patients with treatment- ...