An observational study in Depression, sponsored by VA Office of Research and Development. Active, not recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-10-22.
Sponsored by VA Office of Research and Development · Observational
Veterans with treatment resistant depression (TRD) have the opportunity to receive transcranial magnetic stimulation (TMS) treatment via the VA's National TMS Clinical Pilot Program. While some see improvement with their depression, others do not. Therefore, it may be beneficial to be able to predict with biomarkers what participants may see improvement with their treatment. Electroencephalography (EEG) is a means to identify such biomarkers. Four hundred Veterans with TRD will be enrolled in this trial to determine whether neuroimaging biomarkers of repetitive transcranial magnetic stimulation (TMS) can be prospectively replicated in a large ecologically valid sample. Participants will have a total of EEG scans at baseline, every 5th treatment session, and at the end of treatment for a total of 7 EEG scans.
The goals of this study are to: (1) test a potential predictive resting EEG biomarker of antidepressant response (differential patters of gamma oscillations) in a large sample of Veterans with TRD receiving TMS (N=400); (2) assess whether a second putative biomarker (early changes in theta cordance during treatment) predict eventual response to TMS, as well as, leverage this large sample to identify other potential biomarkers (such as markers of early versus late response to TMS, markers of response to other TMS parameters (e.g., 5 Hz, 1 Hz or theta burst TMS), and markers of change with treatment that may speak to mechanism); and (3) create an infrastructure to rapidly identify and test additional EEG-based biomarkers of treatment response in patients with depression and other psychiatric conditions.
8,057 studies on the registry are indexed under Depression; 1,641 are open to participants now.
This study's enrollment of 266 is above the median of 160 across 1,084 observational studies indexed under Depression.
Browse Depression studies →VA Office of Research and Development is the lead sponsor of 1,733 studies on the registry; 396 are open to participants now.
Of its 206 completed or terminated interventional studies of FDA-regulated products, 180 (87%) have results posted.
Counted across the registry records on this site, refreshed daily.
Veterans with major depressive disorder (MDD) participating in the VA Clinical TMS Pilot Program. Given the complex nature of the Veteran population, the primary diagnosis of MDD may be comorbid with other disorders, including post-traumatic stress disorder (PTSD).
Exclusion Criteria:
Transcranial Magnetic Stimulation is delivered as part of routine care and is not managed by this observational study.
Other: Transcranial Magnetic Stimulation
Transcranial Magnetic Stimulation is delivered as part of routine care and is not managed by this observational study.
Also known as: TMS; Repetitive Transcranial Magnetic Stimulation
Change in Inventory of Depressive Symptomatology-Self Report (IDS-SR)
The IDS-SR is a 30-item self-report depressive symptom severity rating scale. The IDS-SR has been shown to have highly acceptable psychometric properties and has been found to be a treatment sensitive measures of symptom severity in depression. Each question is on a scale of 0 to 4. The IDS-SR has a score range between 0 to 84, with a higher score reflecting higher symptom severity in depression.
Time frame: 1) Baseline, pre-treatment and 2) 6 weeks, treatment completion
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Plan to share: No
This study is active, not recruiting, as verified in Oct 2025. You cannot join it, but the record below documents what was studied.
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VA Office of Research and Development