Treatment Effects on Platelet Calcium in Hypertensive and Depressed Patients

This study has been completed.
Sponsor:
Collaborator:
SmithKline Beecham
Information provided by:
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT00018759
First received: July 3, 2001
Last updated: January 20, 2009
Last verified: December 2004
  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:


Further study details as provided by Department of Veterans Affairs:

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

Ages Eligible for Study:   25 Years to 65 Years
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
SmithKline Beecham
  More Information

No publications provided

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 August 28, 2014