Platelet Function in Patients Treated With SSRI and Non-SSRI Antidepressants

NCT00009568 | Completed

• 2 other identifiers: 01007701-CC-0077
• Study Type: observational
• Target: 70
• Locations: 1 country
• Sites: 1

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, 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.

Conditions

Depression

Keywords

Antidepressants; Platelet Function; SSRI; Depression; Bleeding Time

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• National Institutes of Health Clinical Center (CC): lead

Study Sites (1)

Warren G. Magnuson Clinical Center (CC)

Bethesda, Maryland, 20892, United States

Location

Related Publications (2)

• Alderman CP, Moritz CK, Ben-Tovim DI. Abnormal platelet aggregation associated with fluoxetine therapy. Ann Pharmacother. 1992 Dec;26(12):1517-9. doi: 10.1177/106002809202601205.

  PMID: 1482806 BACKGROUND

• Berk M, Jacobson BF, Hurly E. Fluoxetine and hemostatic function: a pilot study. J Clin Psychiatry. 1995 Jan;56(1):14-6.

  PMID: 7836333 BACKGROUND

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Study Design

• Study Type: observational
• Sponsor Type: NIH

Study Record Dates

• First Submitted: February 1, 2001
• First Posted: February 2, 2001
• Study Start: January 1, 2001
• Study Completion: January 1, 2005
• Last Updated: March 4, 2008

Record last verified: 2005-01

Locations

US (1)