Study Stopped
Study terminated as a result of the dissolution of the Sponsor.
Assessment of the Safety and Effectiveness of Cortical Stimulation in Subjects With Major Depressive Disorder
PROSPECT
Feasibility Study of the Safety and Effectiveness of Cortical Stimulation for Subjects With Major Depressive Disorder
1 other identifier
interventional
12
1 country
3
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1 depression
Started Sep 2006
Typical duration for phase_1 depression
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2006
CompletedFirst Submitted
Initial submission to the registry
September 21, 2006
CompletedFirst Posted
Study publicly available on registry
September 25, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2009
CompletedDecember 31, 2009
September 1, 2008
1.1 years
September 21, 2006
December 30, 2009
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Hamilton Depression Rating Scale (HDRS28)
8 weeks after implant surgery
Secondary Outcomes (1)
10-item Montgomery-Asberg Depression Rating Scale (MADRS)
8 weeks after implant surgery
Study Arms (2)
Active Stimulation
ACTIVE COMPARATORSham
SHAM COMPARATORInterventions
Cortical stimulation of prefrontal cortex
Eligibility Criteria
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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
Massachusetts General Hospital
Boston, Massachusetts, 02129, United States
University of Pittsburgh
Pittsburgh, Pennsylvania, 15213, United States
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226, United States
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
September 21, 2006
First Posted
September 25, 2006
Study Start
September 1, 2006
Primary Completion
October 1, 2007
Study Completion
March 1, 2009
Last Updated
December 31, 2009
Record last verified: 2008-09