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NCT00305565 · ClinicalTrials.gov registry record · Phase 4
Study Comparing Outcomes for Patients With Treatment Resistant Depression Who Receive VNS Therapy at Different Doses
A Phase 4 study, sponsored by Cyberonics.
- Completed
- Registry status
- Phase 4
- Development phase
- 331
- Enrollment target
NCT00305565: Completed Phase 4 study, sponsored by Cyberonics.
NCT00305565 is a Phase 4 study that has completed, run by Cyberonics. The registered enrollment target is 331 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (36% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00305565, a Phase 4 study, has completed, sponsored by Cyberonics.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 331 participants
- Enrollment target
Study Summary
This is a postmarket medical device study. The objective of this study is to compare the safety and effectiveness of Vagus Nerve Stimulation (VNS) Therapy administered at different amounts of electrical charge for the treatment of patients with treatment-resistant depression (TRD).
Primary Outcome
The 30-item Inventory of Depressive Symptomatology (IDS-C/SR) (Rush et al. 1986, 1996) is designed to assess the severity of depressive symptoms. Scale range minimum = 0 / maximum = 84. Higher values are considered to be worse outcomes.
Interventions
- DEVICE VNS Therapy
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 331 participants |
| Start Date | 2006-01 |
| Est. Completion | 2010-02 |
| Phase | Phase 4 |
What the finished NCT00305565 record still lists
NCT00305565 is an interventional study that assigns participants to a tested intervention. The registered 331 participants enrollment target is mid-sized for trials with a published cap, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (36% lower).
The record links to 0 conditions, and to 1 intervention - of which VNS Therapy is the first listed.
NCT00305565 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00305565 about?
NCT00305565 is a clinical study titled "Study Comparing Outcomes for Patients With Treatment Resistant Depression Who Receive VNS Therapy at Different Doses". This is a postmarket medical device study. The objective of this study is to compare the safety and effectiveness of Vagus Nerve Stimulation (VNS) Therapy administered at different amounts of electrical charge for the treatment of patients with treatment-resistant depression (TRD).
What is the current status of trial NCT00305565?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 331 participants. The study started on 2006-01. Estimated completion is 2010-02.
What interventions are being tested in trial NCT00305565?
The interventions under investigation include: VNS Therapy (DEVICE).
Who is sponsoring clinical trial NCT00305565?
This trial is sponsored by Cyberonics, which has 15 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00305565's enrollment target sits among peer trials
331 253rd of 2000 higher than 1,748 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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