Theta Burst Stimulation for Major Depression

(RADIANT Trial)

Overseen By Gaurav Badhan, BS

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: Marta Peciña, MD PhD

Must not be taking: Psychiatric medications

Disqualifiers: Pregnancy, Psychotic disorders, Severe substance use, others

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

Compensation: Varies

Number of Visits: 3

Duration: 3 weeks

200 Participants Needed

Trial Summary

What is the purpose of this trial?

The goal of this clinical trial is to learn how different types of non-invasive brain stimulation affect mood and brain function in adults with major depressive disorder (MDD). It will also study how brain stimulation may work together with antidepressant treatments. The main questions this study aims to answer are: How do different patterns of brain stimulation affect mood in people with depression? Do brain networks involved in emotion and self-reflection respond differently depending on the type of stimulation? What are the combined effects of brain stimulation and antidepressant treatments on mood and brain activity? Researchers will compare different brain stimulation patterns and target areas to understand their individual and combined effects. Participants will: Receive three types of brain stimulation (intermittent, continuous, and sham) in different sessions Undergo MRI scans during the administration of either a fast-acting or conventional antidepressant Complete mood assessments during the scan and for one week after each session This study may help identify brain-based strategies to improve treatment for depression.

Research Team

Marta Pecina, MD, PhD

Principal Investigator

University of Pittsburgh

Eligibility Criteria

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

1. Adults ages 18-55 (\~60% female).

2. Diagnosis of Major Depressive Disorder (MDD) with or without comorbid anxiety disorders (e.g., panic disorder) or Axis II disorders.

3. Psychotropic-free at enrollment.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

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.

3 weeks

3 visits (in-person)

Follow-up

Participants are monitored for mood changes and brain activity through daily remote assessments for one week after each stimulation session.

3 weeks

Treatment Details

Interventions

• Theta Burst Stimulation

Trial Overview The study tests how intermittent theta burst stimulation, continuous theta burst stimulation, and sham (placebo) treatments affect mood in people with depression. It also examines the interaction between these stimulations and antidepressant medications using MRI scans and mood assessments.

Participant Groups

Group I: Salience Network Target Experimental Treatment 3 Interventions

Intermittent/Sham/Continuous TBS, counterbalanced in order.

Group II: Default Mode Network Target Experimental Treatment 3 Interventions

Intermittent/Sham/Continuous TBS, counterbalanced in order.

Who Is Running the Clinical Trial?

Marta Peciña, MD PhD

Lead Sponsor

Trials

3

Recruited

210+