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

This study has been terminated.
(Study terminated as a result of the dissolution of the Sponsor.)
Sponsor:
Information provided by:
Northstar Neuroscience
ClinicalTrials.gov Identifier:
NCT00380042
First received: September 21, 2006
Last updated: December 30, 2009
Last verified: September 2008
  Purpose

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 Intervention Phase
Depression
Depressive Disorder
Device: Cortical Stimulation
Device: Sham
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Feasibility Study of the Safety and Effectiveness of Cortical Stimulation for Subjects With Major Depressive Disorder

Resource links provided by NLM:


Further study details as provided by Northstar Neuroscience:

Primary Outcome Measures:
  • Hamilton Depression Rating Scale (HDRS28) [ Time Frame: 8 weeks after implant surgery ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 10-item Montgomery-Asberg Depression Rating Scale (MADRS) [ Time Frame: 8 weeks after implant surgery ] [ Designated as safety issue: No ]

Estimated Enrollment: 12
Study Start Date: September 2006
Study Completion Date: March 2009
Primary Completion Date: October 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00380042

Locations
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
  More Information

Additional Information:
No publications provided

Responsible Party: VP Clinical Affairs, Northstar Neuroscience
ClinicalTrials.gov Identifier: NCT00380042     History of Changes
Other Study ID Numbers: V0479
Study First Received: September 21, 2006
Last Updated: December 30, 2009
Health Authority: United States: Food and Drug Administration

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

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

ClinicalTrials.gov processed this record on April 21, 2014