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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: Completed Phase 2 study, sponsored by MedtronicNeuro.
NCT00837486 is a Phase 2 study that has completed, run by MedtronicNeuro. The registered enrollment target is 30 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (77% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Montgomery-Åsberg Depression Rating Scale (MADRS); total score can range from 0 (no symptoms) to 60 (severe depression). Response is defined as at least a 50% improvement (decline) in MADRS score. Responder rate is the proportion of participants who experience response.
Interventions
- DEVICE Reclaim™ DBS System
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2009-02 |
| Est. Completion | 2013-04 |
| Phase | Phase 2 |
What the finished NCT00837486 record still lists
NCT00837486 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 30 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (77% lower).
The record links to 0 conditions, and to 1 intervention - of which Reclaim™ DBS System is the first listed.
NCT00837486 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00837486's enrollment target sits among peer trials
30 1582nd of 2000 higher than 332 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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