Status:
COMPLETED
Reclaim Deep Brain Stimulation Clinical Study for Treatment-Resistant Depression
Lead Sponsor:
MedtronicNeuro
Conditions:
Depression
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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 m...
Eligibility Criteria
Inclusion
- Consent to participate in screening and study procedures by signing and dating the Informed Consent Form
- Are diagnosed with major depressive disorder (MDD)
- Have tried at least 4 different treatments, for example antidepressant medications, combinations of antidepressant medications, and/or electroconvulsive therapy (ECT)
- Screening MADRS score ≥ 28
- Have had the current major depressive episode persist for at least 2 years
- Females, if of child-bearing potential, must be using an acceptable method of birth control
Exclusion
- Females: Currently pregnant
- Currently enrolled in or plan to enroll in any concurrent drug and/or device study that may confound the results of this study
- Have a neurological condition that may jeopardize the safety or the conduct of the study
- Have any medical conditions unsuitable for undergoing DBS surgery
Key Trial Info
Start Date :
February 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2013
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT00837486
Start Date
February 1 2009
End Date
April 1 2013
Last Update
May 28 2015
Active Locations (5)
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1
Massachusetts General Hospital
Charlestown, Massachusetts, United States, 02129
2
Cleveland Clinic Foundation
Cleveland, Ohio, United States, 44195
3
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
4
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States, 15213