Ignite Creation Date:
2024-05-05 @ 12:02 PM
Last Modification Date:
2024-10-26 @ 9:18 AM
Study NCT ID:
NCT00215137
Status:
COMPLETED
Last Update Posted:
2014-07-23
First Post:
2005-09-20
Brief Title:
Pilot Study to Evaluate Escitalopram in Obsessive-compulsive Disorder
Sponsor:
Duke University
Organization:
Duke University
Study Overview
Official Title:
Pilot Study to Evaluate Escitalopram in Obsessive-compulsive Disorder
Status:
COMPLETED
Status Verified Date:
2013-08
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 determine the safety and effectiveness of escitalopram Lexaproin treating obsessive-compulsive disorder OCD symptoms
Detailed Description:
OCD is a chronic and disabling disorder for which Selective Serotonin Reuptake InhibitorSSRI drugs can be effective The purpose of this study is to evaluate the effects of an SSRI escitalopram in OCD patients
This study will last 16 weeks and will comprise 2 phases Phase 1 is an open label in which all participants will receive daily escitalopram for 8 weeks Those who have responded to treatment at the end of the 8 weeks will be randomly assigned to either continue or discontinue their treatment for an additional 8 weeks Those who do not respond to treatment at the end of Phase 1 will discontinue the study and be offered three free visits with a study clinician or referred elsewhere for treatment based on the their preference Study visits are made at baseline and at Weeks 1 2 4 and 8 in Phase 1 and Weeks 12 and 16 in Phase 2
This study will last 16 weeks and will comprise 2 phases Phase 1 is an open label in which all participants will receive daily escitalopram for 8 weeks Those who have responded to treatment at the end of the 8 weeks will be randomly assigned to either continue or discontinue their treatment for an additional 8 weeks Those who do not respond to treatment at the end of Phase 1 will discontinue the study and be offered three free visits with a study clinician or referred elsewhere for treatment based on the their preference Study visits are made at baseline and at Weeks 1 2 4 and 8 in Phase 1 and Weeks 12 and 16 in Phase 2
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 |
|---|---|---|---|
| 5731-04-4R0 | OTHER | Duke legacy protocol number | None |