Assessment of the Safety and Effectiveness of Cortical Stimulation in Subjects With Major Depressive Disorder

Study Overview
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Brief Summary
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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
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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.

Official Title
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Feasibility Study of the Safety and Effectiveness of Cortical Stimulation for Subjects With Major Depressive Disorder

Conditions
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Depression, Depressive Disorder

Intervention / Treatment
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* Device: Cortical Stimulation
* Device: Sham


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Active Stimulation<br> | Device: Cortical Stimulation<br>* Cortical stimulation of prefrontal cortex<br>* Other names: Northstar Depression Treatment System (DTS);|
| Sham Comparator: Sham<br> | Device: Sham<br>* Sham stimulation<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hamilton Depression Rating Scale (HDRS28) |  | 8 weeks after implant surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 10-item Montgomery-Asberg Depression Rating Scale (MADRS) |  | 8 weeks after implant surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cortical Electrical Stimulation, Treatment Resistant Depression, Major Depressive Disorder