An interventional study of Repetitive Transcranial Magnetic Stimulation in Major Depressive Disorder, Opioid Use Disorder and Suicidality, sponsored by Baylor College of Medicine. Recruiting at 1 site in United States. Open to participants aged 18 Years to 64 Years. Per ClinicalTrials.gov, last updated 2026-10-13.
Sponsored by Baylor College of Medicine · Not applicable, Interventional, and Treatment
Depression is a leading cause of disability worldwide with a 19% lifetime prevalence in the United States. Dysfunctional reward processing is one of the core features of depression. Common treatments of depression include psychological therapies (e.g., cognitive behavioral therapy), medication (e.g., bupropion, sertraline) and psychological therapies and medication combined, but they may not address the function of the reward circuit in depression. These treatments often o not improve depressive symptoms in patients with depression who are classified as having treatment-resistant depression, and they may be unlikely to respond to further medication trials. Transcranial magnetic stimulation (TMS) is a non-invasive brain stimulation that enables us to selectively excite or inhibit neural activity. Multiple TMS pulses given consecutively are known as repetitive TMS (rTMS), and the primary clinical location for applying rTMS is the left dorsolateral prefrontal cortex (DLPFC) for treatment of depressive symptoms. Many of these studies have shown that rTMS to the DLPFC may result in decreased depressive symptoms, but is only partially effective (response and remission rates of 41.2 and 35.3%, respectively). This evidence supports the importance of evaluating the efficacy of rTMS in other brain regions, such as the orbitofrontal cortex (OFC), in the treatment of depressive symptoms rather than in the DLPFC.
The OFC is functionally connected to other cortical brain regions (e.g., prefrontal and parietal cortices) but also to subcortical areas in the dorsal striatum, a core reward circuitry region. The OFC is structurally connected to the medial forebrain bundle (MFB), deep brain stimulation (DBS) target for depression, and the OFC may in fact be the mediator of anti-depressant effect. The functional connectivity between the OFC and those subcortical brain regions also plays an important role in addiction and suicide behaviors, which are depression's most common comorbidities. Thus, it is clear that we need a better understanding of the therapeutic mechanisms using non-invasive brain stimulation (e.g., TMS) treatment to the OFC as applied to patients with depression. As such, we propose to use a combination of interleaved TMS-fMRI, a novel method to observe and characterize causal manipulations of functional neural circuits, targeting the OFC and resting state fMRI to longitudinally study depressive symptoms and depression-related symptoms (e.g., addiction, suicidal behaviors) changes in patients with depression.
2,805 studies on the registry are indexed under Depressive Disorder, Major; 565 are open to participants now.
This study's planned enrollment of 50 is below the median of 80 across 2,338 interventional studies indexed under Depressive Disorder, Major.
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Exclusion Criteria:
20 sessions of rTMS
Device: Repetitive Transcranial Magnetic Stimulation
5 iTBS sessions per day for 5 consecutive days
Device: Repetitive Transcranial Magnetic Stimulation
1. 4 weeks of active rTMS (total of up to 20 sessions) 2. 5 sessions per day for 5 consecutive days (total of up to 25 sessions)
Functional connectivity of orbital frontal cortex (OFC)
Functional connectivity of OFC changes after receiving TMS treatment
Time frame: 20 days or 5 days
Clinical outcomes
Clinical outcomes include depressive symptoms, craving symptoms, and suicidal behaviors
Time frame: 6 months
Plan to share: No
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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