Ignite Creation Date:
2024-05-05 @ 5:06 PM
Last Modification Date:
2024-10-26 @ 9:27 AM
Study NCT ID:
NCT00380042
Status:
TERMINATED
Last Update Posted:
2009-12-31
First Post:
2006-09-21
Brief Title:
Assessment of the Safety and Effectiveness of Cortical Stimulation in Subjects With Major Depressive Disorder
Sponsor:
Northstar Neuroscience
Organization:
Northstar Neuroscience
Study Overview
Official Title:
Feasibility Study of the Safety and Effectiveness of Cortical Stimulation for Subjects With Major Depressive Disorder
Status:
TERMINATED
Status Verified Date:
2008-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Study terminated as a result of the dissolution of the Sponsor
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PROSPECT
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 routine attempts at controlling their depression
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 year accounting for 44 of the overall global disease burden In the United States about 95 or 19 million people are affected by a depressive disorder with a lifetime risk of about 17 for a major depressive disorder
While depression can be effectively treated in the majority of patients by medication and psychotherapy up to 20 of patients fail to respond Electroconvulsive Therapy ECT is effective in approximately 70 of cases where antidepressant medications do not provide sufficient relief of symptoms However as many as 20-50 of the people who respond well to a course of ECT relapse within 6 months therefore periodic maintenance therapy is often required
For those patients who are resistant to the therapies noted above more invasive approaches have been used including Vagus Nerve Stimulation VNS and more recently Deep Brain Stimulation DBS
Direct cortical stimulation of the cortex via an implanted device system may provide long lasting benefit with minimal side effects The current study seeks to assess in a feasibility study the safety and efficacy of stimulating the prefrontal cortex in patients with major depressive disorder
While depression can be effectively treated in the majority of patients by medication and psychotherapy up to 20 of patients fail to respond Electroconvulsive Therapy ECT is effective in approximately 70 of cases where antidepressant medications do not provide sufficient relief of symptoms However as many as 20-50 of the people who respond well to a course of ECT relapse within 6 months therefore periodic maintenance therapy is often required
For those patients who are resistant to the therapies noted above more invasive approaches have been used including Vagus Nerve Stimulation VNS and more recently Deep Brain Stimulation DBS
Direct cortical stimulation of the cortex via an implanted device system may provide long lasting benefit with minimal side effects The current study seeks to assess in a feasibility study the safety and efficacy of stimulating the prefrontal cortex in patients with major depressive disorder
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None