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.
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.
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.