Platelet Function in Patients Treated With SSRI and Non-SSRI Antidepressants
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|ClinicalTrials.gov Identifier: NCT00009568|
Recruitment Status : Completed
First Posted : February 2, 2001
Last Update Posted : March 4, 2008
|First Submitted Date||February 1, 2001|
|First Posted Date||February 2, 2001|
|Last Update Posted Date||March 4, 2008|
|Study Start Date||January 2001|
|Primary Completion Date||Not Provided|
|Current Primary Outcome Measures||Not Provided|
|Original Primary Outcome Measures||Not Provided|
|Change History||Complete list of historical versions of study NCT00009568 on ClinicalTrials.gov Archive Site|
|Current Secondary Outcome Measures||Not Provided|
|Original Secondary Outcome Measures||Not Provided|
|Current Other Pre-specified Outcome Measures||Not Provided|
|Original Other Pre-specified Outcome Measures||Not Provided|
|Brief Title||Platelet Function in Patients Treated With SSRI and Non-SSRI Antidepressants|
|Official Title||Platelet Dysfunction in Patients Treated With SSRI Versus Non-SSRI Antidepressants|
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, D.C.
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 and/or 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 Design||Not Provided|
|Target Follow-Up Duration||Not Provided|
|Sampling Method||Not Provided|
|Study Population||Not Provided|
|Study Groups/Cohorts||Not Provided|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Original Enrollment||Same as current|
|Study Completion Date||January 2005|
|Primary Completion Date||Not Provided|
Male or female subjects with a diagnosis of depression over the age of 18 years,
Subjects currently prescribed and taking a stable dose of SSRI for at least 6 weeks, or
Subjects currently prescribed and taking a stable dose of bupropion for at least 6 weeks.
Inherited or acquired coagulopathies or platelet disorders
Abnormal thyroid function (TSH less than 0.42 or greater than 4.4 micro IU/ml and free T4 less than 1.0 or greater than 1.9 ng/dL).
Severe depression as indicated by the following: Major depressive disorder single episode, severe without psychotic features DSM-IV 296.23; Major depressive disorder single episode, severe with psychotic features DSM-IV 296.24; Major depressive disorder recurrent, severe without psychotic features DSM-IV 296.33; Major depressive disorder recurrent, severe with psychotic features DSM-IV 296.34.
Patients who are currently receiving coumadin or heparin, non-steroidal antiinflammatory drugs (NSAIDs), acetylsalicylic acid (Aspirin), corticosteroids, chemotherapy, or other medications known to interfere with platelet function studies will not be eligible.
Patients taking NSAIDS and aspirin or other medications known to interfere with platelet function studies will be eligible if they discontinue these medications for more than 10 days prior to testing.
Patients who are taking the following psychotropic medications: valproic acid, carbamazepine, buspiron, atypical antipsychotics, or any other psychotropic medications will not be eligible.
|Ages||Child, Adult, Older Adult|
|Accepts Healthy Volunteers||No|
|Contacts||Contact information is only displayed when the study is recruiting subjects|
|Listed Location Countries||United States|
|Removed Location Countries|
|Other Study ID Numbers||010077
|Has Data Monitoring Committee||Not Provided|
|U.S. FDA-regulated Product||Not Provided|
|IPD Sharing Statement||Not Provided|
|Responsible Party||Not Provided|
|Study Sponsor||National Institutes of Health Clinical Center (CC)|
|PRS Account||National Institutes of Health Clinical Center (CC)|
|Verification Date||January 2005|