Ignite Creation Date:
2024-05-05 @ 4:40 PM
Last Modification Date:
2024-10-26 @ 9:23 AM
Study NCT ID:
NCT00299611
Status:
TERMINATED
Last Update Posted:
2013-04-11
First Post:
2006-03-06
Brief Title:
Augmentation Study of Levetiracetam in Obsessive Compulsive Disorder
Sponsor:
Duke University
Organization:
Duke University
Study Overview
Official Title:
A Double-Blind Augmentation Study of LEvetiracetam in Obsessive Compulsive Disorder
Status:
TERMINATED
Status Verified Date:
2010-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Sponsor decided to terminate the study due to budget consideration
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to evaluate the effectiveness of Levetiracetam augmentation relative to Placebo in SSRI non-remitters with obsessive compulsive disorder The hypothesis is that anxiolytic effect of Levetiracetam is more beneficial when adding with a SSRI
Detailed Description:
This is an investigator-initiated single-site study consisting of two phases 8 weeks of open-label treatment with sertraline 50mg-150mgday in patients iwth OCDAt week 8 those who have failed to achieve remission will be continued on sertraline and will be randomized to receive Levetiracetam 500mg-2000mgday or Placebo for 8 weeks
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