Status:
TERMINATED
Assessment of the Safety and Effectiveness of Cortical Stimulation in Subjects With Major Depressive Disorder
Lead Sponsor:
Northstar Neuroscience
Conditions:
Depression
Depressive Disorder
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
The purpose of this study is to assess the safety and effectiveness of cortical stimulation to the cerebral cortex of subjects who have suffered from treatment-resistant depression and have failed rou...
Detailed Description
Major depressive disorders are the most common of all psychiatric disorders. The World Health Organization estimates that 340 million people worldwide suffer from an episode of major depression each y...
Eligibility Criteria
Inclusion
- Current major depressive episode (MDE) lasting for at least two years, or at least 4 lifetime MDEs with the current episode lasting for at least one year
- Severe depression at study entry defined as a minimum score of 20 on the Hamilton Depression Rating Scale
- Failed response to at least four different antidepressant treatments
Exclusion
- Axis I psychiatric diagnoses including schizophrenia, bipolar disorder, panic disorder, obsessive compulsive disorder, or evidence of global cognitive impairment
- An Axis II diagnoses of either: a) borderline personality disorder, or b) histrionic personality disorder
- Electroconvulsive therapy within 6 months prior to enrollment
- Known need of electroconvulsive therapy while the investigational device is implanted
- History of seizure disorder or status epilepticus
Key Trial Info
Start Date :
September 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2009
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT00380042
Start Date
September 1 2006
End Date
March 1 2009
Last Update
December 31 2009
Active Locations (3)
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1
Massachusetts General Hospital
Boston, Massachusetts, United States, 02129
2
University of Pittsburgh
Pittsburgh, Pennsylvania, United States, 15213
3
Medical College of Wisconsin
Milwaukee, Wisconsin, United States, 53226