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

Stopped early · Phase 1 · Has a placebo group

Conditions studied: Depression, Depressive Disorder

In brief

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.

Key facts

Study ID

NCT00380042

Run by

Northstar Neuroscience

People needed

12

Starts

2006-09-01

Expected to finish

2009-03-01

Last updated by the study team

2009-12-31

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Massachusetts General Hospital — Boston, Massachusetts, United States
• University of Pittsburgh — Pittsburgh, Pennsylvania, United States
• Medical College of Wisconsin — Milwaukee, Wisconsin, United States

Full record on ClinicalTrials.gov

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