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| Sponsors and Collaborators: |
Department of Veterans Affairs SmithKline Beecham |
| Information provided by: | Department of Veterans Affairs |
| ClinicalTrials.gov Identifier: | NCT00018759 |
Purpose
This study aims to determine if treatment with an SSRI antidepressant medication, paroxetine, is associated with cellular calcium response to serotonin, platelet serotonin receptors, and improvement in mood in depressed patients with or without hypertension. It is hypothesized that platelets of hypertensive patients with depressive symptomatology with be hyper-responsive to serotonin. Additionally, treatment with an SSRI antidepressant is expected to produce a down-regulation of the serotonin receptor with an associated reduction in platelet cytosolic calcium response as well as improved mood.
| Condition | Intervention | Phase |
|
Depression Hypertension |
Drug: paroxetine Behavioral: ongoing psychological screening |
Phase IV |
| MedlinePlus related topics: | Antidepressants Depression High Blood Pressure |
| Drug Information available for: | Paroxetine Paroxetine hydrochloride Paroxetine Mesylate Calcium gluconate Serotonin |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double-Blind, Parallel Assignment, Pharmacodynamics Study |
| Official Title: | Treatment Effects on Platelet Calcium in Hypertensive and Depressed Patients |
Eligibility
| Ages Eligible for Study: | 25 Years to 65 Years |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | Yes |
Subjects for all study groups will be male and between the ages of 25 and 65
Hypertension & Depression Group: Hypertension controlled with an ACE-inhibitor anti-hypertensive; no co-morbid medical conditions known to influence psychological functioning or platelet calcium responses including uncontrolled diabetes, MI or CVA within 6 months of enrollment, secondary hypertension; depression as diagnosed by structured interview and HDRS score of 18; no active participation in another clinical trial; no current suicidal/ homicidal ideation
Hypertension Group: Hypertension controlled with an ACE-inhibitor anti-hypertensive; no co-morbid medical conditions known to influence psychological functioning or platelet calcium responses including uncontrolled diabetes, MI or CVA within 6 months of enrollment, secondary hypertension; no active participation in another clinical trial; no current suicidal/ homicidal ideation
Depression Group: No co-morbid medical conditions known to influence psychological functioning or platelet calcium responses including uncontrolled diabetes, MI or CVA within 6 months of enrollment, secondary hypertension; depression as diagnosed by structured interview and HDRS score of 18; no active participation in another clinical trial; no current suicidal/ homicidal ideation
Contacts and Locations| United States, Illinois | |||||
| Edward Hines Jr. Hospital | |||||
| Hines, Illinois, United States, 60141 | |||||
| Department of Veterans Affairs |
| SmithKline Beecham |
More Information
| Study ID Numbers: | MHBS-023-00S |
| First Received: | July 3, 2001 |
| Last Updated: | June 23, 2005 |
| ClinicalTrials.gov Identifier: | NCT00018759 |
| Health Authority: | United States: Federal Government |
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