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Treatment Effects on Platelet Calcium in Hypertensive and Depressed Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00018759
Recruitment Status : Completed
First Posted : July 5, 2001
Last Update Posted : January 21, 2009
Sponsor:
Collaborator:
SmithKline Beecham
Information provided by:
VA Office of Research and Development

Study Description
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Brief Summary:
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 or disease Intervention/treatment Phase
Depression Hypertension Drug: paroxetine Behavioral: ongoing psychological screening Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Treatment Effects on Platelet Calcium in Hypertensive and Depressed Patients
Study Start Date : March 2001
Study Completion Date : October 2003

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Calcium
Drug Information available for: Paroxetine

Arms and Interventions
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Outcome Measures
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Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   25 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00018759


Locations
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United States, Illinois
Edward Hines Jr. Hospital
Hines, Illinois, United States, 60141
Sponsors and Collaborators
US Department of Veterans Affairs
SmithKline Beecham
More Information
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ClinicalTrials.gov Identifier: NCT00018759    
Other Study ID Numbers: MHBS-023-00S
First Posted: July 5, 2001    Key Record Dates
Last Update Posted: January 21, 2009
Last Verified: December 2004
Keywords provided by VA Office of Research and Development:
Serotonin, Hypertension, Depression
Additional relevant MeSH terms:
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Hypertension
Depression
Vascular Diseases
Cardiovascular Diseases
Behavioral Symptoms
Paroxetine
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
 Neurotransmitter Agents
Serotonin Agents
Physiological Effects of Drugs
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Cytochrome P-450 CYP2D6 Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors