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NCT00837486 · ClinicalTrials.gov registry record · Phase 2
Reclaim Deep Brain Stimulation Clinical Study for Treatment-Resistant Depression
A Phase 2 study, sponsored by MedtronicNeuro.
- Completed
- Registry status
- Phase 2
- Development phase
- 30
- Enrollment target
NCT00837486 is a Phase 2 study that has completed, run by MedtronicNeuro. The registered enrollment target is 30 participants.
The verdict
NCT00837486, a Phase 2 study, has completed, sponsored by MedtronicNeuro.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 30 participants
- Enrollment target
Study Summary
Medtronic, Inc. sponsored an investigational study of the Reclaim™ Deep Brain Stimulation (DBS) System in people that have treatment-resistant depression. Depression is a mood disorder and a serious medical condition that affects millions of Americans. Depressive symptoms may include loss of interest in things typically enjoyed; decreased energy levels; difficulty concentrating or making decisions; restlessness; and feelings of pessimism, hopelessness, and worthlessness. Treatment-resistant depression is a chronic and severe form of depression characterized by failure to respond to traditional forms of treatment, such as antidepressant medications and electroconvulsive therapy. Treatment-resistant depression significantly impacts quality of life, productivity, and is a major contributor of disability world-wide. This randomized, double-blind, sham stimulation-controlled, multi-center, prospective, parallel design study used deep brain stimulation technology to test whether active bilateral stimulation can safely and effectively improve depressive symptoms in patients with treatment-resistant depression compared to sham stimulation. Participants meeting criteria for the study were implanted with the Reclaim DBS System. Participants in the active group, who received active stimulation, were compared to the control group, who received sham stimulation, during the 16-week blinded-treatment phase. All participants were monitored for changes in depressive symptoms. After the blinded-treatment phase, all participants received active stimulation. Candidates for the trial were adults who had major depressive disorder and had not responded to several treatments for depression. Participants in the study continued to receive their current antidepressant medications while participating in the trial.
Interventions
- DEVICE Reclaim™ DBS System
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2009-02 |
| Est. Completion | 2013-04 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00837486
The ClinicalTrials.gov registry entry for NCT00837486 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 30 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is MedtronicNeuro, which has 51 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Reclaim™ DBS System is the first listed.
NCT00837486 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00837486 about?
NCT00837486 is a clinical study titled "Reclaim Deep Brain Stimulation Clinical Study for Treatment-Resistant Depression". Medtronic, Inc. sponsored an investigational study of the Reclaim™ Deep Brain Stimulation (DBS) System in people that have treatment-resistant depression. Depression is a mood disorder and a serious medical condition that affects millions of Americans. Depressive symptoms may include loss of interes...
What is the current status of trial NCT00837486?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 30 participants. The study started on 2009-02. Estimated completion is 2013-04.
What interventions are being tested in trial NCT00837486?
The interventions under investigation include: Reclaim™ DBS System (DEVICE).
Who is sponsoring clinical trial NCT00837486?
This trial is sponsored by MedtronicNeuro, which has 51 total clinical trials registered on ClinicalTrials.gov.
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