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

Sponsor

Northstar Neuroscience (Industry)

Overall Status

Terminated

CT.gov ID

NCT00380042

Collaborator

(none)

Enrollment

Locations

Arms

Duration (Months)

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Depression Depressive Disorder	Device: Cortical Stimulation Device: Sham	Phase 1

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 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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

12 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

Single (Participant)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Sep 1, 2006

Actual Primary Completion Date :

Oct 1, 2007

Actual Study Completion Date :

Mar 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Active Stimulation	Device: Cortical Stimulation Cortical stimulation of prefrontal cortex Other Names: Renova Cortical Stimulation System Northstar Depression Treatment System (DTS)
Sham Comparator: Sham	Device: Sham Sham stimulation

Arm

Intervention/Treatment

Active Comparator: Active Stimulation

Device: Cortical Stimulation

Cortical stimulation of prefrontal cortex

Other Names:

Renova Cortical Stimulation System

Northstar Depression Treatment System (DTS)

Sham Comparator: Sham

Device: Sham

Sham stimulation

Outcome Measures

Primary Outcome Measures

Hamilton Depression Rating Scale (HDRS28) [8 weeks after implant surgery]

Secondary Outcome Measures

10-item Montgomery-Asberg Depression Rating Scale (MADRS) [8 weeks after implant surgery]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Massachusetts General Hospital	Boston	Massachusetts	United States	02129
2	University of Pittsburgh	Pittsburgh	Pennsylvania	United States	15213
3	Medical College of Wisconsin	Milwaukee	Wisconsin	United States	53226