Ignite Creation Date:
2024-05-05 @ 10:21 PM
Last Modification Date:
2024-10-26 @ 10:17 AM
Study NCT ID:
NCT01085461
Status:
COMPLETED
Last Update Posted:
2012-03-05
First Post:
2010-03-10
Brief Title:
Assessment of Suicidality in Epilepsy - Rating Tools
Sponsor:
The Epilepsy Study Consortium
Organization:
The Epilepsy Study Consortium
Study Overview
Official Title:
Assessment of Suicidality in Epilepsy - Rating Tools
Status:
COMPLETED
Status Verified Date:
2012-03
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:
ASERT
Brief Summary:
This will be a cross-sectional study enrolling 200 outpatientsinpatients with treatment resistant partial epilepsy for at least two years receiving 1-3 AEDS
The study will consist of one or two visits each lasting 1-2 hours All subjects will complete Visit 1 Twenty five percent of the subjects will return for Visit 2 The study will assess the prevalence of depression and suicidal thoughts and the feasibility of using the proposed psychiatric rating scales in future epilepsy clinical trials This study will also provide an estimate of the proportion of patients with epilepsy PWE who may be ineligible for future trials
The study will consist of one or two visits each lasting 1-2 hours All subjects will complete Visit 1 Twenty five percent of the subjects will return for Visit 2 The study will assess the prevalence of depression and suicidal thoughts and the feasibility of using the proposed psychiatric rating scales in future epilepsy clinical trials This study will also provide an estimate of the proportion of patients with epilepsy PWE who may be ineligible for future trials
Detailed Description:
In light of the recent issues regarding antiepileptic drugs and suicidality The Epilepsy Study Consortium is proposing a pilot study Several scales to assess suicidality and screen for depression and anxiety disorders will be administered to a group of epilepsy patients with characteristics similar to patients who are usually enrolled in epilepsy clinical trials The study will assess the prevalence of depression suicidal thoughts and behavior and the feasibility of using the proposed psychiatric rating scales in future epilepsy clinical trials This study will also provide an estimate of the proportion of patients with epilepsy who may be ineligible for future trials because they have had active suicidal thoughts in the last 6 months suicidal behavior in the last 2 years or a current major depressive episode
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