Depression Clinical Trial
— PROSPECTOfficial title:
Feasibility Study of the Safety and Effectiveness of Cortical Stimulation for Subjects With Major Depressive Disorder
Verified date | September 2008 |
Source | Northstar Neuroscience |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Food and Drug Administration |
Study type | Interventional |
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 routine attempts at controlling their depression.
Status | Terminated |
Enrollment | 12 |
Est. completion date | March 2009 |
Est. primary completion date | October 2007 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - 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 Criteria: - 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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Massachusetts General Hospital | Boston | Massachusetts |
United States | Medical College of Wisconsin | Milwaukee | Wisconsin |
United States | University of Pittsburgh | Pittsburgh | Pennsylvania |
Lead Sponsor | Collaborator |
---|---|
Northstar Neuroscience |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Hamilton Depression Rating Scale (HDRS28) | 8 weeks after implant surgery | No | |
Secondary | 10-item Montgomery-Asberg Depression Rating Scale (MADRS) | 8 weeks after implant surgery | No |
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