- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00017836
Mechanisms Linking Depression to Cardiovascular Risk
Study Overview
Status
Conditions
Detailed Description
BACKGROUND:
Multiple studies have demonstrated a higher risk of cardiovascular disease and worse cardiovascular disease (CVD) prognosis associated with depression that appear to synergistically and significantly adversely impact health. Because these initial studies are observational, much work remains to understand this area. If these conditions are mechanistically inter-related, identification of both conditions in the same subject may provide a means of enhancing risk stratification and most appropriately targeting therapy. If the interaction between the conditions is causal not simply associative, appropriate therapy interventions can be designed and tested.
DESIGN NARRATIVE:
The project is designed to clarify the role of depression on CVD risk by using a co-twin study design. The study will examine twin pairs from the Vietnam Era Twin Registry (VET). Twin pairs will be invited to participate if they meet two criteria: (1) neither has a history of CVD as of 1990 and (2) one twin is diagnosed with depression as of 1992. The study investigates the effects of depression on two indicators of "early" CVD: coronary flow reserve, assessed by means of Positron Emission Tomography (PET) myocardial infusion imaging; and heart rate variability (HRV) assessed by ambulatory electrocardiographic monitoring. It is hypothesized that within each pair, the twins who have clinical depression will exhibit lower coronary vascular reserve and lower heart rate variability compared with their co-twins without a history of depression. Moreover, by comparing the size of the intra-pair difference in these parameters between depression discordant monozygotic and dizygotic twins an estimate of the relative contributions of gene and environmental factors can be ascertained. In addition to the PET and HRV assessments, subjects will complete the Statistical Clinical Interview of the Diagnostic and Statistical Manual of Mental Disorders (DSM-IV SCID) to document a history of depression, a psychometric battery including the Early Trauma Inventory and Hamilton Depression Scale, and such risk factors as cigarette smoking, physical activity, blood pressure and blood lipids, glucose and insulin, indices of inflammation and thrombogenicity including levels of reactive protein C, fibrinogen, and P-selectin, and neurohormones such as adrenocorticotropic hormone, cortisol, and dehydroepiandrosterone sulphate.
Study Type
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Study Plan
How is the study designed?
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Viola Vaccarino, Emory University
Publications and helpful links
General Publications
- Eufinger SC, Votaw J, Faber T, Ziegler TR, Goldberg J, Bremner JD, Vaccarino V. Habitual dietary sodium intake is inversely associated with coronary flow reserve in middle-aged male twins. Am J Clin Nutr. 2012 Mar;95(3):572-9. doi: 10.3945/ajcn.111.018077. Epub 2012 Jan 18.
- Karohl C, Su S, Kumari M, Tangpricha V, Veledar E, Vaccarino V, Raggi P. Heritability and seasonal variability of vitamin D concentrations in male twins. Am J Clin Nutr. 2010 Dec;92(6):1393-8. doi: 10.3945/ajcn.2010.30176. Epub 2010 Oct 13.
- Dai J, Ziegler TR, Bostick RM, Manatunga AK, Jones DP, Goldberg J, Miller A, Vogt G, Wilson PW, Jones L, Shallenberger L, Vaccarino V. High habitual dietary alpha-linolenic acid intake is associated with decreased plasma soluble interleukin-6 receptor concentrations in male twins. Am J Clin Nutr. 2010 Jul;92(1):177-85. doi: 10.3945/ajcn.2010.29305. Epub 2010 May 12.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRB00024823
- 970 (Other Identifier: NIH ID)
- R01HL068630 (U.S. NIH Grant/Contract)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Depression
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University GhentUniversiteit Antwerpen; Janssen-Cilag Ltd.RecruitingDepression Moderate | Depression Severe | Depression MildBelgium
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Baylor College of MedicineUniversity of TexasRecruitingDepression | Depression Moderate | Depression Severe | Suicide and Self-harm | Depression in Adolescence | Depression MildUnited States
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University of Cape TownNational Institute of Mental Health (NIMH)CompletedPostpartum Depression | Clinical Depression | Moderate DepressionSouth Africa
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Washington University School of MedicinePatient-Centered Outcomes Research Institute; National Institute of Mental...CompletedMajor Depressive Disorder | Treatment Resistant Depression | Treatment-Refractory Depression | Late Life Depression | Geriatric DepressionUnited States, Canada
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Northern Illinois UniversityUniversity Autonoma de Santo DomingoTerminatedDepression Moderate | Depression MildUnited States, Dominican Republic
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Gerbera Therapeutics, Inc.Not yet recruitingPostpartum Depression | Depression, Postpartum | Postnatal Depression | Post-partum Depression | Post-Natal DepressionUnited States