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Trial record 99 of 1053 for:    "Depressive Disorder" [DISEASE] AND Rating AND Hamilton Depression Rating Scale

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00380042
Recruitment Status : Terminated (Study terminated as a result of the dissolution of the Sponsor.)
First Posted : September 25, 2006
Last Update Posted : December 31, 2009
Information provided by:
Northstar Neuroscience

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.

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Study Type : Interventional  (Clinical Trial)
Estimated 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 : September 2006
Actual Primary Completion Date : October 2007
Actual Study Completion Date : March 2009

Resource links provided by the National Library of Medicine

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

Primary Outcome Measures :
  1. Hamilton Depression Rating Scale (HDRS28) [ Time Frame: 8 weeks after implant surgery ]

Secondary Outcome Measures :
  1. 10-item Montgomery-Asberg Depression Rating Scale (MADRS) [ Time Frame: 8 weeks after implant surgery ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00380042

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United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02129
United States, Pennsylvania
University of Pittsburgh
Pittsburgh, Pennsylvania, United States, 15213
United States, Wisconsin
Medical College of Wisconsin
Milwaukee, Wisconsin, United States, 53226
Sponsors and Collaborators
Northstar Neuroscience

Additional Information:
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Responsible Party: VP Clinical Affairs, Northstar Neuroscience Identifier: NCT00380042     History of Changes
Other Study ID Numbers: V0479
First Posted: September 25, 2006    Key Record Dates
Last Update Posted: December 31, 2009
Last Verified: September 2008

Keywords provided by Northstar Neuroscience:
Cortical Electrical Stimulation
Treatment Resistant Depression
Major Depressive Disorder

Additional relevant MeSH terms:
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Depressive Disorder
Depressive Disorder, Major
Pathologic Processes
Behavioral Symptoms
Mood Disorders
Mental Disorders