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

Depression Clinical Trial

— PROSPECT  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00380042
• Other study ID #: V0479
• Status: Terminated
• Phase: Phase 1
• First received: September 21, 2006
• Last updated: December 30, 2009
• Start date: September 2006
• Est. completion date: March 2009

Study information

• Verified date: September 2008
• Source: Northstar Neuroscience
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 12
• Est. completion date: March 2009
• Est. primary completion date: October 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major

Intervention

Device:
• Cortical Stimulation
Cortical stimulation of prefrontal cortex
• Sham
Sham stimulation

Locations

Country	Name	City	State
United States	Massachusetts General Hospital	Boston	Massachusetts
United States	Medical College of Wisconsin	Milwaukee	Wisconsin
United States	University of Pittsburgh	Pittsburgh	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Northstar Neuroscience

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hamilton Depression Rating Scale (HDRS28)		8 weeks after implant surgery	No
Secondary	10-item Montgomery-Asberg Depression Rating Scale (MADRS)		8 weeks after implant surgery	No

External Links

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