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NCT00320372 · ClinicalTrials.gov registry record
Treatment-Resistant Depression Registry
A clinical trial, sponsored by Cyberonics.
- Completed
- Registry status
- 795
- Enrollment target
NCT00320372: Completed study, sponsored by Cyberonics.
NCT00320372 is a clinical trial that has completed, run by Cyberonics. The registered enrollment target is 795 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00320372 has completed, sponsored by Cyberonics.
- COMPLETED
- Registry status
- 795 participants
- Enrollment target
Study Summary
This registry will collect information about patients with treatment-resistant depression (TRD) who are currently in a major depressive episode. For the purposes of this study, TRD is defined as an ongoing depression lasting at least 2 years or that has recurred at least 3 times, to include the current episode, during the patient's lifetime AND has not adequately responded to 4 or more adequate antidepressive treatments. The registry will follow the clinical course and outcomes for patients with TRD who are treated with and without adjunctive (used along with other treatments for depression) vagus nerve stimulation (VNS) therapy.
Primary Outcome
Response Rate was computed and summarized as the proportion of patients that achieved ≥ 50% reduction from baseline in MADRS total score at each post-baseline visit. The MADRS is a ten-item diagnostic questionnaire used to measure the severity of depressive episodes in patients with mood disorders. Higher MADRS score indicates more severe depression, and each item yields a score of 0 to 6. The overall score ranges from 0 to 60. The lower a score the less symptom severity is seen. A patient was c
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 795 participants |
| Start Date | 2006-01 |
| Est. Completion | 2015-05 |
What the finished NCT00320372 record still lists
NCT00320372 is an observational study that tracks outcomes without assigning an intervention. The registered 795 participants enrollment target is mid-sized for trials with a published cap.
The record links to 0 conditions, and to 0 interventions.
NCT00320372 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00320372 about?
NCT00320372 is a clinical study titled "Treatment-Resistant Depression Registry". This registry will collect information about patients with treatment-resistant depression (TRD) who are currently in a major depressive episode. For the purposes of this study, TRD is defined as an ongoing depression lasting at least 2 years or that has recurred at least 3 times, to include the curr...
What is the current status of trial NCT00320372?
This trial is currently completed. The enrollment target is 795 participants. The study started on 2006-01. Estimated completion is 2015-05.
Who is sponsoring clinical trial NCT00320372?
This trial is sponsored by Cyberonics, which has 15 total clinical trials registered on ClinicalTrials.gov.
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