Treatment Effects on Platelet Calcium in Hypertensive and Depressed Patients

This study has been completed.

Sponsor:

Collaborator:

SmithKline Beecham

Information provided by:

VA Office of Research and Development

ClinicalTrials.gov Identifier:

NCT00018759

First received: July 3, 2001

Last updated: January 20, 2009

Last verified: December 2004

History of Changes

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

Resource links provided by NLM:

MedlinePlus related topics: Calcium

Drug Information available for: Paroxetine

U.S. FDA Resources

Further study details as provided by VA Office of Research and Development:


Study Start Date:	March 2001
Estimated Study Completion Date:	October 2003

Eligibility


Ages Eligible for Study:	25 Years to 65 Years (Adult)
Genders 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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00018759

Locations


United States, Illinois
Edward Hines Jr. Hospital
Hines, Illinois, United States, 60141

Sponsors and Collaborators

VA Office of Research and Development

SmithKline Beecham

More Information


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 VA Office of Research and Development:


Serotonin, Hypertension, Depression

Additional relevant MeSH terms:


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

ClinicalTrials.gov processed this record on September 27, 2016

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