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

NCT ID: NCT00380042

Last Updated: 2009-12-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE1

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-09-30

Study Completion Date

2009-03-31

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.

Conditions

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Depression Depressive Disorder

Keywords

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Cortical Electrical Stimulation Treatment Resistant Depression Major Depressive Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Active Stimulation

Group Type ACTIVE_COMPARATOR

Cortical Stimulation

Intervention Type DEVICE

Cortical stimulation of prefrontal cortex

Sham

Group Type SHAM_COMPARATOR

Sham

Intervention Type DEVICE

Sham stimulation

Interventions

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Cortical Stimulation

Cortical stimulation of prefrontal cortex

Intervention Type DEVICE

Sham

Sham stimulation

Intervention Type DEVICE

Other Intervention Names

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Renova Cortical Stimulation System Northstar Depression Treatment System (DTS)

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Northstar Neuroscience

INDUSTRY

Sponsor Role lead

Responsible Party

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Northstar Neuroscience

Locations

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Massachusetts General Hospital

Boston, Massachusetts, United States

Site Status

University of Pittsburgh

Pittsburgh, Pennsylvania, United States

Site Status

Medical College of Wisconsin

Milwaukee, Wisconsin, United States

Site Status

Countries

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United States

Related Links

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http://clinicaltrials.gov/ct2/show/NCT00380042

Click here for more information about this study: Cortical Stimulation for Depression

Other Identifiers

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V0479

Identifier Type: -

Identifier Source: org_study_id