Protocol Number: 01-CC-0077

Title:

Platelet Dysfunction in Patients Treated with SSRI Versus Non-SSRI Antidepressants

Number:

01-CC-0077

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, 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.

Sponsoring Institute:

Warren G. Magnuson Clinical Center (CC)

Recruitment Detail

Type: Active Accrual Of New Subjects

Gender: Male & Female

Referral Letter Required: Yes

Population Exclusion(s): None

Eligibility Criteria:

INCLUSION CRITERIA:

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.

EXCLUSION CRITERIA:

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.

Special Instructions: Currently Not Provided

Keywords:

Antidepressants

Platelet Function

SSRI

Recruitment Keywords:

Depression

SSRI

Antidepressants

Bleeding Time

Conditions:

Depression

Investigational Drug(s):

None

Investigational Device(s):

None

Contacts:

Patient Recruitment and Public Liaison Office
Building 61
10 Cloister Court
Bethesda, Maryland 20892-4754
Toll Free: 1-800-411-1222
TTY: 301-594-9774 (local),1-866-411-1010 (toll free)
Fax: 301-480-9793

Electronic Mail:prpl@mail.cc.nih.gov

Citations:

Abnormal platelet aggregation association with fluoxetine therapy

Fluoxetine and hemostatic function: a pilot study

• Questions about participating in a study, please contact the Patient Recruitment and Public Liaison Office, CC.
• Technical questions regarding the Clinical Center web site, please contact the Department of Networks and Applications, CC.

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Bethesda, Maryland 20892. Last update: 10/23/2004