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NCT00951132 Clinical Trial

Depression and Cardiovascular Risk Markers: Effects of Rosuvastatin Therapy

Depression Clinical Trial

— DECAMERONE  

Official title:
Depression and Cardiovascular Risk Markers: Effects of Rosuvastatin Therapy

Clinical Trial Details — Status: Withdrawn

Administrative data
NCT number NCT00951132
Other study ID # AHUSPP0651
Secondary ID
Status Withdrawn
Phase Phase 2
First received
Last updated
Start date September 2009
Est. completion date December 2013

Study information
Verified date January 2023
Source University Hospital, Akershus
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this study is to investigate whether rosuvastatin decreases measures of inflammation in depressive patients.

Description:

Depression is associated with increased risk of cardiovascular disease, in which one possible mechanism is systemic inflammation. Further, patients at high risk of cardiovascular disease, rosuvastatin decreases the risk, especially among patients with increased inflammation. This is a proof-of-concept study to investigate whether the antiinflammatory effect of rosuvastatin is similar in depressive as in patients with cardiovascular disease.

Recruitment information / eligibility
Status Withdrawn
Enrollment 0
Est. completion date December 2013
Est. primary completion date December 2012
Accepts healthy volunteers No
Gender All
Age group 40 Years to 70 Years
Eligibility Inclusion Criteria: - Persisting self-reported depressive symptoms > 5 weeks - Indications of aortic atherosclerosis on PET/CT Exclusion Criteria: - Clinical indication of statin use. - Contraindication of statins, or of PET/CT and MRI. - Established cardiovascular disease. - Bipolar disorder og comorbid psychosis.

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• rosuvastatin
10mg tablets, once daily in three months
• Placebo
tablet, once daily, three months

Locations
Country Name City State
Norway Akershus University Hospital Lorenskog Akershus

Sponsors (3)
Lead Sponsor Collaborator
University Hospital, Akershus AstraZeneca, Oslo University Hospital

Country where clinical trial is conducted

Norway, 

Outcome
Type Measure Description Time frame Safety issue
Primary Mean SUV of large arteries 3 months
Secondary Peripheral endothelial function (pulse wave amplitude) 3 months
Secondary Circulatory proinflammatory markers 3 months
Secondary Heart rate variability 3 months
Secondary Depressive symptoms 3 months
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