Cortical rTMS as a Treatment for Depression

StatusRecruiting
PhaseNot applicable
Started

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Trial flagged as At Risk
Primary completion moved at least 1 year 11 months later Aug 4, 2026 → Jul 31, 2028
Primary endpoint reworded 2 of 2 changed
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Record History

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  1. Notable Primary completion pushed from Aug 4, 2026 to Jul 31, 2028 Show 9 more changesShow less
    • Primary endpoint(s) modified
    • Start date: Aug 1, 2024 to Nov 1, 2026
    • Trial status changed: Enrolling by Invitation → Recruiting
    • Study completion pushed from Aug 4, 2027 to Aug 31, 2028
    • Trial arms changed: 1 → 2
    • Eligibility criteria expanded, about 60 words
    • Site details revised
    • Publications: details revised at 6 of 7 entries
    • Study description expanded, about 1 word
  2. Notable Primary completion date: Aug 4, 2025 to Aug 4, 2026
    • Start date: Jun 14, 2023 to Aug 1, 2024
    • Study completion date: Aug 4, 2026 to Aug 4, 2027
    v4
  3. Notable Start date: Mar 1, 2023 to Jun 14, 2023v3
  4. Notable Trial status: Not Yet Recruiting to Enrolling by Invitation
    • Start date: Aug 4, 2022 to Mar 1, 2023
    • Site contact updated
    v2
  5. Minor Study First Submitted
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
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.
Trial Details
NCT Number NCT05487911
Lead Sponsor Baylor College of Medicine
Conditions
(from sponsor)
Major Depressive Disorder, Opioid Use Disorder, Suicidality
Related terms Major Depressive Disorder, Opioid-Related Disorders, Suicidal Ideation
Enrollment 50 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov