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Deep Brain Stimulation for Treatment Resistant Depression

StatusCompleted
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗

Record History

  1. Trial status: Active, Not Recruiting to Completed Study completion date changed from estimate of Jan 2029 to Jun 14, 2024v30 Show all 2 changesShow less
    • Study completion date changed from estimate of Jan 2029 to Jun 14, 2024
  2. Re-verified, no change to tracked fieldsv29
  3. Completion date: Jan 2024 to Jan 2029v28
  4. 3 versions Re-verified since Jul 12, 2021, no change to tracked fieldsv25-v27
  5. Results first posted: Jul 14, 2020 Trial status: Recruiting to Active, Not Recruiting · Enrollment target: estimated 40 to confirmed 37 · Primary completion date changed from estimate of Nov 2024 to Jan 2, 2014 · 3 morev24 Show all 7 changesShow less
    • Trial status: Recruiting to Active, Not Recruiting
    • Enrollment target: estimated 40 to confirmed 37
    • Primary completion date changed from estimate of Nov 2024 to Jan 2, 2014
    • Completion date: Nov 2024 to Jan 2024
    • Site details revised
    • Publications: 10 to 11

    See this version in full on ClinicalTrials.gov ↗

Show 22 earlier versionsHide 22 earlier versions
  1. Enrollment target: 20 to 40 Primary and study completion dates: Nov 2019 to Nov 2024 · Primary endpoint revised · Interventions: Deep Brain Stimulator, implantable (Device) to Deep Brain Stimulation (Device) · 4 morev23 Show all 8 changesShow less
    • Primary and study completion dates: Nov 2019 to Nov 2024
    • Primary endpoint revised
    • Interventions: Deep Brain Stimulator, implantable (Device) to Deep Brain Stimulation (Device)
    • Eligibility criteria expanded, about 351 words
    • Study description expanded, about 134 words
    • Site contact updated
    • Publications: 7 to 10

    See this version in full on ClinicalTrials.gov ↗

  2. Re-verified, no change to tracked fieldsv22
  3. Primary and study completion dates: Sep 2018 to Nov 2019 Site contact updatedv21 Show all 2 changesShow less
    • Site contact updated
  4. Phase: Phase 1/2 to Not applicablev20
  5. 5 versions Re-verified since Feb 24, 2015, no change to tracked fieldsv15-v19
  6. Primary and study completion dates: Sep 2014 to Sep 2018v14
  7. Site contact updatedv13
  8. Study arms: 0 to 1v12
  9. 3 versions Re-verified since Nov 28, 2011, no change to tracked fieldsv9-v11
  10. Primary and study completion dates: Sep 2011 to Sep 2014 Collaborators: 3 to 1v8 Show all 2 changesShow less
    • Collaborators: 3 to 1

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  11. Eligibility criteria expanded, about 5 wordsv7 Show moreShow less

    See this version in full on ClinicalTrials.gov ↗

  12. Eligibility criteria shortened, about 245 words Study description shortened, about 126 wordsv6 Show all 2 changesShow less
    • Study description shortened, about 126 words

    See this version in full on ClinicalTrials.gov ↗

  13. Eligibility criteria shortened, about 126 words Study description shortened, about 6 wordsv5 Show all 2 changesShow less
    • Study description shortened, about 6 words

    See this version in full on ClinicalTrials.gov ↗

  14. Re-verified, no change to tracked fieldsv4
  15. Primary endpoint revised Primary and study completion dates: Sep 2011v3 Show all 2 changesShow less
    • Primary and study completion dates: Sep 2011

    See this version in full on ClinicalTrials.gov ↗

  16. Study description expanded, about 24 words Collaborators: 2 to 3v2 Show all 2 changesShow less
    • Collaborators: 2 to 3

    See this version in full on ClinicalTrials.gov ↗

  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.
Emory University
375 trials monitored
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Depression
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The purpose of this study is to test the safety, efficacy and mechanism of action of subgenual cingulate (Cg25) deep brain stimulation (DBS) for major depression in patients who have not responded to prior antidepressant treatments. Participation in the study will continue for ten years or until the device receives FDA approval for depression. Forty (40) patients will be enrolled in this study.
Trial Details
NCT Number NCT00367003
Lead Sponsor Emory University
Collaborators: The Dana Foundation
Conditions Major Depressive Disorder
Enrollment 37 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov