Ignite Creation Date:
2024-05-05 @ 11:55 AM
Last Modification Date:
2024-10-26 @ 9:16 AM
Study NCT ID:
NCT00177424
Status:
TERMINATED
Last Update Posted:
2014-06-27
First Post:
2005-09-12
Brief Title:
Sertraline for Preventing Post-stroke Depression and Improving Rehabilitation Outcomes
Sponsor:
University of Pittsburgh
Organization:
University of Pittsburgh
Study Overview
Official Title:
Intervention to Prevent Post-Stroke Major Depression
Status:
TERMINATED
Status Verified Date:
2009-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Recruitment goals could not be met
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 effectiveness of sertraline administration after a stroke in preventing the onset of post-stroke depression
Detailed Description:
Persons who suffer from a stroke are at high risk for developing post-stroke major depression PSMD an illness that has a negative impact on post-stroke physical rehabilitation and is associated with increased morbidity and mortality Unfortunately early detection and successful treatment of post-stroke major depression improves but does not normalize stroke rehabilitation outcomes compared to stroke survivors who never developed post-stroke depression Therefore preventing the onset of PSMD and its associated disability is an attractive possibility This study is a placebo controlled 10-month double-blind trial of sertraline in the prevention of PSMD in stroke survivors with a 2-month naturalistic continuation phase The primary outcome will be the incidence of Major Depression post-stroke Additional outcomes will include the severity of depressive symptoms post-stroke and the level of disability experienced by the two treatment groups An exploratory analysis will also be conducted to elucidate participant characteristics that may be moderators of the participants response to the preventive intervention thereby refining the profile of disabled stroke survivors most likely to benefit from the preventive intervention
For information on a related study please follow this link
httpclinicaltrialsgovshowNCT00781326
For information on a related study please follow this link
httpclinicaltrialsgovshowNCT00781326
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 |
|---|---|---|---|
| K23MH067710-02 | NIH | None | None |
| 0310068 | None | None | None |
| DATR AK-TNGP1 | US NIH GrantContract | None | httpsreporternihgovquickSearchK23MH067710-02 |