Theta Burst Stimulation for Major Depression
(RADIANT Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests how different types of non-invasive brain stimulation, including Theta Burst Stimulation, can improve mood in people with major depressive disorder (MDD). Researchers aim to discover how various brain stimulation patterns affect mood and brain function and how these might interact with antidepressant treatments. Participants will experience three types of brain stimulation and undergo MRI scans to monitor changes in mood and brain activity. The study seeks adults with MDD who are not currently on any psychiatric medication. The goal is to uncover new brain-based treatments for depression. As an unphased trial, this study offers participants the opportunity to contribute to groundbreaking research that could lead to innovative treatments for depression.
Do I have to stop taking my current medications for the trial?
Yes, you must stop taking psychiatric medications or augmenting agents at least 21 days before joining the trial, as participants need to be psychotropic-free at enrollment.
What prior data suggests that this brain stimulation technique is safe for treating major depression?
Research has shown that Theta Burst Stimulation (TBS) is generally safe for individuals with major depressive disorder (MDD). A review of several studies found that different types of TBS, such as intermittent and continuous, are safe. Most participants experienced only mild side effects, like headaches or scalp discomfort, which were short-lived. Another study found that TBS significantly improved mood without causing serious side effects. Overall, these findings suggest that TBS is a safe treatment for depression, with most individuals tolerating it well.12345
Why are researchers excited about this trial?
Researchers are excited about Theta Burst Stimulation (TBS) for major depression because it offers a potentially faster and more focused approach compared to traditional treatments like antidepressants and standard repetitive Transcranial Magnetic Stimulation (rTMS). TBS is unique because it uses short bursts of magnetic pulses to target specific brain networks, such as the Default Mode Network and the Salience Network, which are believed to play key roles in mood regulation. This targeted method could lead to quicker and more precise improvements in depressive symptoms, offering hope for patients who need rapid relief.
What evidence suggests that this trial's treatments could be effective for major depression?
Research has shown that theta burst stimulation (TBS) can help reduce symptoms of major depressive disorder (MDD). Studies have found that TBS significantly improves depression symptoms, with many patients experiencing high rates of response and remission. One review found that TBS works as well as traditional treatments like repetitive transcranial magnetic stimulation (rTMS) but requires less time. Another study showed that TBS was effective for people with treatment-resistant depression over 26 weeks. In this trial, participants will receive TBS targeting either the Default Mode Network or the Salience Network, with intermittent, sham, or continuous TBS applied in a counterbalanced order. Overall, TBS appears to be a promising option for improving mood in people with depression.12345
Who Is on the Research Team?
Marta Pecina, MD, PhD
Principal Investigator
University of Pittsburgh
Are You a Good Fit for This Trial?
This trial is for adults with major depressive disorder (MDD) who are interested in exploring non-invasive brain stimulation as a treatment. Specific eligibility criteria details are not provided, but typically participants must meet diagnostic criteria for MDD and be able to safely undergo MRI scans and brain stimulation.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive three types of brain stimulation (intermittent, continuous, and sham) in different sessions, along with MRI scans and administration of either a fast-acting or conventional antidepressant.
Follow-up
Participants are monitored for mood changes and brain activity through daily remote assessments for one week after each stimulation session.
What Are the Treatments Tested in This Trial?
Interventions
- Theta Burst Stimulation
Find a Clinic Near You
Who Is Running the Clinical Trial?
Marta Peciña, MD PhD
Lead Sponsor