Trials / Completed
CompletedNCT00533832
Pivotal Trial (D02) of Vagus Nerve Stimulation (VNS) for Treatment-Resistant Depression (TRD)
A Multicernter, Pivotal, Safety and Efficacy Study of the NeuroCtybernetic Prosthesis (NCP(R)) System in Patients With Depression
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 266 (actual)
- Sponsor
- Cyberonics, Inc. · Industry
- Sex
- All
- Age
- 18 Years – 80 Years
- Healthy volunteers
- Not accepted
Summary
To confirm the safety and efficacy of the NCP System in treating patients in a nmajor depressive episode.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | vagus nerve stimulation (VNS) | intermittent vagus nerve stimulation Placebo group were implanted, but did not receive vagus nerve stimulation during the acute phase. |
Timeline
- Start date
- 2000-07-01
- Completion
- 2005-07-01
- First posted
- 2007-09-24
- Last updated
- 2007-09-24
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT00533832. Inclusion in this directory is not an endorsement.