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DBS for Depression

StatusActive, Not Recruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 12 months later Aug 19, 2026 → Aug 19, 2027
See other at-risk trials from Baylor College of Medicine

Record History

  1. Primary and study completion pushed from Aug 19, 2026 to Aug 19, 2027 Enrollment closed, study ongoing · Eligibility criteria expanded, about 36 words · Study description revised · 2 more Show 5 more changesShow less
    • Enrollment closed, study ongoing
    • Eligibility criteria expanded, about 36 words
    • Study description revised
    • Site details revised at 2 of 2 sites
    • Publications: details revised at 2 of 2 entries
  2. Re-verified, no change to tracked fieldsv19
  3. Study title shortened, about 11 wordsv18 See this version in full on ClinicalTrials.gov ↗
  4. Primary and study completion dates: Aug 19, 2025 to Aug 19, 2026v17
  5. Site details revised at 2 of 2 sitesv16
Show 14 earlier versionsHide 14 earlier versions
  1. Primary completion date: Aug 19, 2023 to Aug 19, 2025 Completion date: Aug 19, 2024 to Aug 19, 2025v15 Show 1 more changeShow less
    • Completion date: Aug 19, 2024 to Aug 19, 2025
  2. Eligibility criteria expanded, about 85 words Study sites revised (2) · Collaborator revisedv14 Show 2 more changesShow less
    • Study sites revised (2)
    • Collaborator revised

    See this version in full on ClinicalTrials.gov ↗

  3. Trial status: Active, Not Recruiting to Recruiting Site details revised at 2 of 2 sitesv13 Show 1 more changeShow less
    • Site details revised at 2 of 2 sites
  4. Trial status: Recruiting to Active, Not Recruiting Site details revised at 2 of 2 sitesv12 Show 1 more changeShow less
    • Site details revised at 2 of 2 sites
  5. Eligibility criteria expanded, about 15 wordsv11 See this version in full on ClinicalTrials.gov ↗
  6. Site details revised at 1 of 2 sitesv10
  7. Eligibility criteria expanded, about 23 words Site contacts updated at 1 of 2 sitesv9 Show 1 more changeShow less
    • Site contacts updated at 1 of 2 sites

    See this version in full on ClinicalTrials.gov ↗

  8. Site contacts updated at 1 of 2 sitesv8
  9. Trial status: Not Yet Recruiting to Recruiting Primary completion date: Sep 30, 2023 to Aug 19, 2023 · Completion date: Sep 30, 2024 to Aug 19, 2024 · Start date changed from estimate of Oct 1, 2019 to Aug 20, 2019 · 1 morev7 Show 4 more changesShow less
    • Primary completion date: Sep 30, 2023 to Aug 19, 2023
    • Completion date: Sep 30, 2024 to Aug 19, 2024
    • Start date changed from estimate of Oct 1, 2019 to Aug 20, 2019
    • Site details revised at 2 of 2 sites
  10. Start date: Aug 1, 2019 to Oct 1, 2019v6
  11. Site contacts updated at 1 of 2 sitesv5
  12. Lead sponsor: Columbia University to Baylor College of Medicine Trial status: Withdrawn to Not Yet Recruiting · Primary completion date: Jun 30, 2022 to Sep 30, 2023 · Start date: May 1, 2018 to Aug 1, 2019 · 5 morev4 Show 8 more changesShow less
    • Trial status: Withdrawn to Not Yet Recruiting
    • Primary completion date: Jun 30, 2022 to Sep 30, 2023
    • Start date: May 1, 2018 to Aug 1, 2019
    • Enrollment target: 0 to 12
    • Study sites: 0 to 2
    • Completion date: Jun 30, 2023 to Sep 30, 2024
    • Eligibility criteria expanded, about 96 words
    • Collaborators: 2 to 1

    See this version in full on ClinicalTrials.gov ↗

  13. Collaborators reorderedv3
  14. Trial status: Not Yet Recruiting to Withdrawn Sponsor's reason: PI left institution Enrollment target: estimated 12 to confirmed 0 · Study sites: 1 to 0v2 Show 2 more changesShow less
    • Enrollment target: estimated 12 to confirmed 0
    • Study sites: 1 to 0
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • 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.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
The goal of the study is to address the unmet need of TRD patients by identifying brain networks critical for treating depression and to use next generation precision DBS with steering capability to engage these targeted networks. The study's goal will be achieved through 3 specific aims: 1. Demonstrate device capability to selectively and predictably engage distinct brain networks 2. Delineate depression-relevant networks and demonstrate behavioral changes with network-targeted stimulation 3. Demonstrate that chronic DBS using steered, individualized targeting is feasible and safe for reducing depressive symptoms
Trial Details
NCT Number NCT03437928
Lead Sponsor Baylor College of Medicine
Collaborators: University of Texas
Conditions Major Depressive Disorder
Enrollment 12 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov