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Biological CVD Risk Factors in Older Depressed Patients

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00318864
First Posted: April 27, 2006
Last Update Posted: April 27, 2006
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Stanford University
  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
Intervention Model: Single Group Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Stress, the HPA and Health in Aging

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

Information from the National Library of Medicine

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Ages Eligible for Study:   55 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • age > 55 years, hypertensive or hypercholesterolemic, depressed

Exclusion Criteria:

  • suicidal
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

ClinicalTrials.gov Identifier: NCT00318864     History of Changes
Other Study ID Numbers: CBarrTaylor
5P01AG018784-02 ( U.S. NIH Grant/Contract )
First Submitted: April 25, 2006
First Posted: April 27, 2006
Last Update Posted: April 27, 2006
Last Verified: April 2006

Keywords provided by Stanford University:
depression
cardiovascular risk
mechanisms

Additional relevant MeSH terms:
Depression
Hypercholesterolemia
Behavioral Symptoms
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases