Treatment Effects on Platelet Calcium in Hypertensive and Depressed Patients
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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 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Pharmacodynamics Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment |
| 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
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More Information
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| ClinicalTrials.gov Identifier: | NCT00018759 History of Changes |
| Other Study ID Numbers: | MHBS-023-00S |
| Study First Received: | July 3, 2001 |
| Last Updated: | January 20, 2009 |
| Health Authority: | United States: Federal Government |
Keywords provided by Department of Veterans Affairs:
|
Serotonin, Hypertension, Depression |
Additional relevant MeSH terms:
|
Depression Depressive Disorder Hypertension Behavioral Symptoms Mood Disorders Mental Disorders Vascular Diseases Cardiovascular Diseases Paroxetine Serotonin Uptake Inhibitors Neurotransmitter Uptake Inhibitors |
Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Serotonin Agents Physiological Effects of Drugs Antidepressive Agents, Second-Generation Antidepressive Agents Psychotropic Drugs Central Nervous System Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 23, 2013