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Sponsored by: |
Northstar Neuroscience |
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Information provided by: | Northstar Neuroscience |
ClinicalTrials.gov Identifier: | NCT00380042 |
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.
Condition | Intervention | Phase |
---|---|---|
Depression Depressive Disorder |
Device: Cortical Stimulation Device: Sham Stimulation |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Single Blind (Subject), Active Control, Crossover Assignment, Safety/Efficacy Study |
Official Title: | Feasibility Study of the Safety and Effectiveness of Cortical Stimulation for Subjects With Major Depressive Disorder |
Estimated Enrollment: | 12 |
Study Start Date: | September 2006 |
Arms | Assigned Interventions |
---|---|
Active Stimulation: Active Comparator |
Device: Cortical Stimulation
Cortical stimulation of prefrontal cortex
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Sham Stimulation: Sham Comparator |
Device: Sham Stimulation
Sham stimulation
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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 4.4% of the overall global disease burden. In the United States, about 9.5% 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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, Massachusetts | |
Massachusetts General Hospital | |
Boston, Massachusetts, United States, 02129 | |
United States, Pennsylvania | |
University of Pittsburgh | |
Pittsburgh, Pennsylvania, United States, 15213 | |
United States, Wisconsin | |
Medical College of Wisconsin | |
Milwaukee, Wisconsin, United States, 53226 |
Responsible Party: | Northstar Neuroscience ( VP Clinical Affairs ) |
Study ID Numbers: | V0479 |
Study First Received: | September 21, 2006 |
Last Updated: | December 18, 2007 |
ClinicalTrials.gov Identifier: | NCT00380042 |
Health Authority: | United States: Food and Drug Administration |
Cortical Electrical Stimulation Treatment Resistant Depression Major Depressive Disorder |
Depression Mental Disorders Mood Disorders |
Depressive Disorder, Major Depressive Disorder Behavioral Symptoms |
Pathologic Processes Disease |