Ignite Creation Date:
2024-05-05 @ 11:07 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00009568
Status:
COMPLETED
Last Update Posted:
2008-03-04
First Post:
2001-02-01
Brief Title:
Platelet Function in Patients Treated With SSRI and Non-SSRI Antidepressants
Sponsor:
National Institutes of Health Clinical Center CC
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Platelet Dysfunction in Patients Treated With SSRI Versus Non-SSRI Antidepressants
Status:
COMPLETED
Status Verified Date:
2005-01
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 examine the effect of a class of antidepressant medications called selective serotonin reuptake inhibitors SSRIs on platelet function Platelets are small blood cells that help stop bleeding after injury to a blood vessel by forming a clot or plug in the vessel Some medications impair platelet function leading to increased bruising and bleeding SSRIs decrease an important platelet component called serotonin which may cause bleeding in some patients SSRIs include fluoxetine Prozac sertraline Zoloft paroxetine Paxil fluvoxamine Luvox and citalopram Celexa
Patients 18 years of age and older being treated for depression with a SSRI or the non-SSRI bupropion Wellbutrin may be eligible for this study Subjects will be recruited from a private clinic in Washington DC
Participants will provide a history of their current medications and past history of bleeding They will have about 4 tablespoons of blood drawn for tests to measure blood cell counts and platelet function The study takes about 1 hour The results of the SSRI-treated group and the bupropion-treated group will be analyzed and compared
This study may provide information that will help health care providers make treatment decisions to minimize possible adverse effects of medications in patients with depression
Patients 18 years of age and older being treated for depression with a SSRI or the non-SSRI bupropion Wellbutrin may be eligible for this study Subjects will be recruited from a private clinic in Washington DC
Participants will provide a history of their current medications and past history of bleeding They will have about 4 tablespoons of blood drawn for tests to measure blood cell counts and platelet function The study takes about 1 hour The results of the SSRI-treated group and the bupropion-treated group will be analyzed and compared
This study may provide information that will help health care providers make treatment decisions to minimize possible adverse effects of medications in patients with depression
Detailed Description:
This study will evaluate platelet function in patients during treatment with selective serotonin reuptake inhibitors SSRIs which are widely used antidepressant agents SSRIs which are known to decrease platelet serotonin content have been reported to be associated with bleeding in a minority of patients and recently have been associated with an increase in gastrointestinal bleeding The purpose of this study is to better understand the potential risks of bleeding associated with mild platelet dysfunction in patients using SSRIs and to determine whether a global test of platelet function as performed on the platelet function analyzer-100 is able to identify the changes in platelet function associated with SSRI use Until recently platelet function testing has utilized platelet aggregation studies which are very labor-intensive and require highly skilled technicians a newer instrument the Platelet Function Analyzer-100 PFA-100 Dade Behring Deerfield IL requires much less technical input to evaluate platelet function The patients will be selected from a private clinic in the Washington DC area and will undergo a baseline assessment history of bleeding andor thrombosis blood tests for routine blood counts chemistries and platelet function using the PFA-100 The analysis will include a statistical comparison of the platelet function in patients on SSRIs with those on a non-SSRI antidepressant medication bupropion It will also include an analysis of the results of the PFA-100 compared to the results of platelet aggregation The results of the study may provide a better understanding of platelet function and screening for platelet function defects in patients using SSRIs
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 |
|---|---|---|---|
| 01-CC-0077 | None | None | None |