Treatment Effects on Platelet Calcium in Hypertensive and Depressed Patients

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.

Study Overview

• Status: Completed
• Conditions: Depression; Hypertension
• Intervention / Treatment: Drug: paroxetine; Behavioral: ongoing psychological screening

• Study Type: Interventional
• Phase: Phase 4

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 25 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Collaborators and Investigators

• Sponsor: US Department of Veterans Affairs
• Collaborators: SmithKline Beecham

Study record dates

Study Major Dates

• Study Start: March 1, 2001
• Study Completion: October 1, 2003

Study Registration Dates

• First Submitted: July 3, 2001
• First Submitted That Met QC Criteria: July 4, 2001
• First Posted (Estimate): July 5, 2001

Study Record Updates

• Last Update Posted (Estimate): January 21, 2009
• Last Update Submitted That Met QC Criteria: January 20, 2009
• Last Verified: December 1, 2004

More Information

Terms related to this study

• Keywords: Serotonin, Hypertension, Depression
• Additional Relevant MeSH Terms: Behavioral Symptoms; Cardiovascular Diseases; Vascular Diseases; Depression; Hypertension; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Psychotropic Drugs; Serotonin Uptake Inhibitors; Neurotransmitter Uptake Inhibitors; Membrane Transport Modulators; Serotonin Agents; Antidepressive Agents; Cytochrome P-450 Enzyme Inhibitors; Antidepressive Agents, Second-Generation; Cytochrome P-450 CYP2D6 Inhibitors; Paroxetine
• Other Study ID Numbers: MHBS-023-00S