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Platelet Function in Patients Treated with SSRI and non-SSRI Antidepressants Clinical Trials Facts presented on Clinical Trials Search is not designed to be a substitute for certified medical advice, travels to or professional assistance by using a genuine doctor. We aren't mDs. Always consult your physician about Platelet Function in Patients Treated with SSRI and non-SSRI Antidepressants conditions. Clinical Trials Search.org is a website committed to listing clinical research studies in human subjects. Platelet Function in Patients Treated with SSRI and non-SSRI Antidepressants Clinical research trials and Platelet Function in Patients Treated with SSRI and non-SSRI Antidepressants health trials occur in a lot of of cities throughout the US. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally evaluate the potency of new does drugs. The role of the studies / undertakings is to figure out specific human healthcare questions. Clinical trials are a popular manner for mDs, government agencies, and private sector companies to locate treatments for all sorts of conditions, including Platelet Function in Patients Treated with SSRI and non-SSRI Antidepressants. Platelet Function in Patients Treated with SSRI and non-SSRI Antidepressants Clinical Trials and other clinical trials permit volunteers to get medical treatment choices before they are available to the general public. Many times the test subjects get professional assistance for free of charge, and occasionally they are compensated for their time. Sometimes there is a cost for a Platelet Function in Patients Treated with SSRI and non-SSRI Antidepressants clinical trial. Human subjects often get the best healthcare possible for their Platelet Function in Patients Treated with SSRI and non-SSRI Antidepressants condition. Risks are a reality, nevertheless, and could include additional or frequent dr. calls, medical hazards (perhaps life-threatening), and/or the treatment being ineffectual. Trials are federally governed with exacting guidelines to protect clinical trials patients.
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Home > "P" Clinical Trials Conditions > Platelet Function in Patients Treated with SSRI and non-SSRI Antidepressants  Platelet Function in Patients Treated with SSRI and non-SSRI Antidepressants
Platelet Function in Patients Treated with SSRI and non-SSRI Antidepressants
For Condition: Depression
Status: Recruiting
Sponsor(s): Warren G Magnuson Clinical Center (CC) ,
Synopsis: 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.
Details: 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.
Eligibility:
Study Type: Observational, Natural History
Minimum Age/Maximum Age: /
Genders: Both
Protocol Entry 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.
Total Enrollment: 70
Location and Contact Information:
Warren G. Magnuson Clinical Center (CC) *Recruiting*
Bethesda, Maryland, 20892
United States
Recruiting Patient and Public Liaison Office 1-800-411-1222
Additional Information:
Study ID Numbers: 010077; 01-CC-0077
Study Start Date: January 28, 2001
Record last reviewed: January 8, 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00009568
Other Depression Studies:
1. Brain Imaging in Depression
2. Treatment Of Resistant Depression In Adolescents (TORDIA)
3. Clinical Trial of Fluoxetine in Anxiety and Depression in Children, and Associated Brain Changes
4. Duloxetine vs. active comparator in the treatment of patients with depression
5. Depression In Juvenile Diabetics
Related Studies:
Other Depression Clinical Trials
Other Maryland Clinical Trials
Other Bethesda Clinical Trials
Platelet Function in Patients Treated with SSRI and non-SSRI Antidepressants
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