Biological CVD Risk Factors in Older Depressed Patients

This study has been completed.
Sponsor:
Information provided by:
Stanford University
ClinicalTrials.gov Identifier:
NCT00318864
First received: April 25, 2006
Last updated: NA
Last verified: April 2006
History: No changes posted
  Purpose

The purpose of this study is to determine if improvements in mood will ameliorate autonomic dysregulation, HPA dysfunction and typical (e.g. lipids) and atypical risk factors in depressed patients with elevated cardiovascular risk (CVD). Up to 70, depressed participants with elevated cardiovascular risk factors were randomized to a cognitive behavioral intervention (CBT) or a waiting list control (WLC) condition. Twenty non-depressed age and risk-matched controls will also recruited. Traditional risk factors (e.g. lipids, blood pressure, heart rate), atypical risk factors (endothelial function, asymmetric dimethylarginine, C-reactive protein) will be measured pre and post treatment six months later Subjects will undergo a psychophysiological stress test while cardiovascular physiology was measured. Salivary cortisol will be measured during the day and during the psychological stress test. Depressed subjects will be randomized to a 16 week cognitive behavior therapy intervention or to a wait-list control. It is hypothesized that reduction in mood will be associated with reduction in typical and atypical risk factors.


Condition Intervention
Depression
Hypertension
Hypercholesterolemia
Behavioral: Cognitive behavioral therapy

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Single Group Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Stress, the HPA and Health in Aging

Resource links provided by NLM:


Further study details as provided by Stanford University:

Primary Outcome Measures:
  • Change in depression

Secondary Outcome Measures:
  • Change in typical and atypical risk factors

Estimated Enrollment: 70
Study Start Date: June 2002
Estimated Study Completion Date: July 2005
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   55 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • age > 55 years, hypertensive or hypercholesterolemic, depressed

Exclusion Criteria:

  • suicidal
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00318864

Locations
United States, California
Stanford Medical Center
Stanford, California, United States, 94305
Sponsors and Collaborators
Stanford University
Investigators
Principal Investigator: Craig B Taylor Stanford Medical Center
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00318864     History of Changes
Other Study ID Numbers: CBarrTaylor, 5 p01 AG18784-02
Study First Received: April 25, 2006
Last Updated: April 25, 2006
Health Authority: United States: Institutional Review Board

Keywords provided by Stanford University:
depression
cardiovascular risk
mechanisms

Additional relevant MeSH terms:
Depression
Depressive Disorder
Hypercholesterolemia
Hypertension
Behavioral Symptoms
Cardiovascular Diseases
Dyslipidemias
Hyperlipidemias
Lipid Metabolism Disorders
Mental Disorders
Metabolic Diseases
Mood Disorders
Vascular Diseases

ClinicalTrials.gov processed this record on October 22, 2014