Deep Brain Stimulation for Treatment Resistant Depression

StatusCompleted
PhaseNot applicable
Started

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Record History

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  1. Trial status: Active, Not Recruiting to Completed
    • Study completion date changed from estimate of Jan 2029 to Jun 14, 2024
    v30
  2. Re-verified, no change to tracked fieldsv29
  3. Study 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, 2020v24 Show 6 more 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
    • Study completion date: Nov 2024 to Jan 2024
    • Site details revised
    • Publications: 10 to 11
Show 22 earlier versionsHide 22 earlier versions
  1. Enrollment target: 20 to 40v23 Show 7 more 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
  2. Re-verified, no change to tracked fieldsv22
  3. Primary and study completion dates: Sep 2018 to Nov 2019
    • Site contact updated
    v21
  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 1
    v8
  11. Eligibility criteria expanded, about 5 wordsv7
  12. Eligibility criteria shortened, about 245 words
    • Study description shortened, about 126 words
    v6
  13. Eligibility criteria shortened, about 126 words
    • Study description shortened, about 6 words
    v5
  14. Re-verified, no change to tracked fieldsv4
  15. Primary endpoint revised
    • Primary and study completion dates: Sep 2011
    v3
  16. Study description expanded, about 24 words
    • Collaborators: 2 to 3
    v2
  1. 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.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Emory University
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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
(from sponsor)		 Major Depressive Disorder
Related terms Depression, Major Depressive Disorder
Enrollment 37 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov