deltatrials
Completed OBSERVATIONAL NCT00320372

Treatment-Resistant Depression Registry

A Long-term, Prospective, Observational, Multi-center Patient Outcome Registry to Collect Data in Patients With Treatment-resistant Depression (TRD) Who Are Currently in a Major Depressive Episode.

Sponsor: Cyberonics, Inc.

Updated 9 times since 2017 Last updated: Dec 22, 2015 Started: Jan 31, 2006 Primary completion: Mar 31, 2015 Completion: May 31, 2015
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

Listed as NCT00320372, this observational or N/A phase trial focuses on Major Depressive Disorder and remains completed. Sponsored by Cyberonics, Inc., it has been updated 9 times since 2006, reflecting limited change activity. This study adds to the evidence base for this therapeutic area through structured, versioned documentation.

Study Description(click to expand)

Enrollment of TRD patients treated with VNS Therapy will consist of patients originally enrolled in the registry as well as patients who have completed the D-21 Dosing Study and are enrolled in the Registry for Long-Term Follow-up. Sites will maintain a screening log of all patients who have been screened for original TRD Registry patients. Please note that because this is a post-approval registry, Cyberonics does not cover the cost of VNS Therapy implantation.

Enrollment of TRD patients treated with VNS Therapy will consist of patients originally enrolled in the registry as well as patients who have completed the D-21 Dosing Study and are enrolled in the Registry for Long-Term Follow-up. Sites will maintain a screening log of all patients who have been screened for original TRD Registry patients.

Please note that because this is a post-approval registry, Cyberonics does not cover the cost of VNS Therapy implantation.

Status Flow

~Jan 2017 – ~Feb 2017 · 31 days · monthly snapshotCompleted~Feb 2017 – ~Apr 2018 · 14 months · monthly snapshotCompleted~Apr 2018 – ~Jun 2018 · 2 months · monthly snapshotCompleted~Jun 2018 – ~Jan 2021 · 31 months · monthly snapshotCompleted~Jan 2021 – ~Jul 2024 · 42 months · monthly snapshotCompleted~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshotCompleted~Sep 2024 – ~Sep 2025 · 12 months · monthly snapshotCompleted~Sep 2025 – present · 7 months · monthly snapshotCompleted~Jan 2026 – present · 3 months · monthly snapshotCompleted

Change History

9 versions recorded
  1. Jan 2026 — Present [monthly]

    Completed

  2. Sep 2025 — Present [monthly]

    Completed

  3. Sep 2024 — Sep 2025 [monthly]

    Completed

  4. Jul 2024 — Sep 2024 [monthly]

    Completed

  5. Jan 2021 — Jul 2024 [monthly]

    Completed

Show 4 earlier versions
  1. Jun 2018 — Jan 2021 [monthly]

    Completed

  2. Apr 2018 — Jun 2018 [monthly]

    Completed

    Phase: NANone

  3. Feb 2017 — Apr 2018 [monthly]

    Completed NA

  4. Jan 2017 — Feb 2017 [monthly]

    Completed NA

    First recorded

Jan 2006

Trial started

Per CT.gov start date — pre-dates our first snapshot

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • Cyberonics, Inc.
Data source: Cyberonics, Inc.

For direct contact, visit the study record on ClinicalTrials.gov .