Ignite Creation Date:
2024-05-05 @ 5:34 PM
Last Modification Date:
2024-10-26 @ 9:33 AM
Study NCT ID:
NCT00488748
Status:
COMPLETED
Last Update Posted:
2015-01-28
First Post:
2007-06-18
Brief Title:
Magnetic Seizure Therapy MST for Severe Mood Disorder
Sponsor:
Sarah Lisanby
Organization:
Duke University
Study Overview
Official Title:
Magnetic Seizure Therapy MST for the Treatment of Severe Mood Disorder
Status:
COMPLETED
Status Verified Date:
2015-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study will compare the clinical efficacy and side effects of Magnetic Seizure Therapy MST and Electroconvulsive Therapy ECT in patients currently experiencing a major depressive episode in the context of either unipolar or bipolar depression The investigators will conduct a number of clinical and neuropsychological tests to assess clinical and cognitive response to treatment The investigators hypothesize that
1 MST and ECT will have similar antidepressant efficacy
2 MST will have less post-treatment amnesia than ECT as reflected in primary measures of anterograde and retrograde amnesia following the acute treatment phase
3 At follow up MST will show a lesser degree of persisting deficit in measures of retrograde amnesia than ECT
1 MST and ECT will have similar antidepressant efficacy
2 MST will have less post-treatment amnesia than ECT as reflected in primary measures of anterograde and retrograde amnesia following the acute treatment phase
3 At follow up MST will show a lesser degree of persisting deficit in measures of retrograde amnesia than ECT
Detailed Description:
The purpose of this study is to compare the clinical efficacy and side effects of Magnetic Seizure Therapy MST and Electroconvulsive Therapy ECT in patients currently experiencing a major depressive episode in the context of either unipolar or bipolar depression ECT is known to be highly effective in treating depression but it can have some adverse cognitive side effects MST is a new form of convulsive therapy that is being developed as a means of improving the side effect profile of ECT so that more patients may benefit without suffering significant detrimental effects on cognition
Both ECT and MST cause a seizure but they do so in different ways In ECT an electrical stimulator is used to pass an electrical current between two electrodes placed on the persons head which causes some electricity to go through the brain and cause a seizure In MST a magnetic stimulator is used to pass a magnetic field to the brain which then creates a small electrical field in the brain that causes a seizure
In addition to the treatment sessions this study will involve a number of assessments at different timepoints that are used to evaluate the persons antidepressant response and the physical and cognitive side effects of treatment
Both ECT and MST cause a seizure but they do so in different ways In ECT an electrical stimulator is used to pass an electrical current between two electrodes placed on the persons head which causes some electricity to go through the brain and cause a seizure In MST a magnetic stimulator is used to pass a magnetic field to the brain which then creates a small electrical field in the brain that causes a seizure
In addition to the treatment sessions this study will involve a number of assessments at different timepoints that are used to evaluate the persons antidepressant response and the physical and cognitive side effects of treatment
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| Stanley Grant 05T656 | None | None | None |