Ignite Creation Date:
2025-12-24 @ 2:22 PM
Ignite Modification Date:
2026-01-01 @ 10:08 AM
Study NCT ID:
NCT00018759
Status:
COMPLETED
Last Update Posted:
2009-01-21
First Post:
2001-07-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Treatment Effects on Platelet Calcium in Hypertensive and Depressed Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003863', 'term': 'Depression'}, {'id': 'D006973', 'term': 'Hypertension'}], 'ancestors': [{'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D017374', 'term': 'Paroxetine'}], 'ancestors': [{'id': 'D010880', 'term': 'Piperidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2001-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2004-12', 'completionDateStruct': {'date': '2003-10'}, 'lastUpdateSubmitDate': '2009-01-20', 'studyFirstSubmitDate': '2001-07-03', 'studyFirstSubmitQcDate': '2001-07-04', 'lastUpdatePostDateStruct': {'date': '2009-01-21', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2001-07-05', 'type': 'ESTIMATED'}}, 'conditionsModule': {'keywords': ['Serotonin, Hypertension, Depression'], 'conditions': ['Depression', 'Hypertension']}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '25 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Subjects for all study groups will be male and between the ages of 25 and 65\n\nHypertension \\& 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\n\nHypertension 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\n\nDepression 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'}, 'identificationModule': {'nctId': 'NCT00018759', 'briefTitle': 'Treatment Effects on Platelet Calcium in Hypertensive and Depressed Patients', 'organization': {'class': 'FED', 'fullName': 'VA Office of Research and Development'}, 'officialTitle': 'Treatment Effects on Platelet Calcium in Hypertensive and Depressed Patients', 'orgStudyIdInfo': {'id': 'MHBS-023-00S'}}, 'armsInterventionsModule': {'interventions': [{'name': 'paroxetine', 'type': 'DRUG'}, {'name': 'ongoing psychological screening', 'type': 'BEHAVIORAL'}]}, 'contactsLocationsModule': {'locations': [{'zip': '60141', 'city': 'Hines', 'state': 'Illinois', 'country': 'United States', 'facility': 'Edward Hines Jr. Hospital', 'geoPoint': {'lat': 41.85364, 'lon': -87.8395}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'US Department of Veterans Affairs', 'class': 'FED'}, 'collaborators': [{'name': 'SmithKline Beecham', 'class': 'INDUSTRY'}]}}}