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Depression and Cardiovascular Risk Markers: Effects of Rosuvastatin Therapy

Depression and Cardiovascular Risk Markers: Effects of Rosuvastatin Therapy

Status
Withdrawn
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00951132
Acronym
DECAMERONE
Enrollment
0
Registered
2009-08-04
Start date
2009-09-30
Completion date
2013-12-31
Last updated
2023-02-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Depression

Keywords

Inflammation, Atherosclerosis, Hydroxymethylglutaryl-CoA Reductase Inhibitors

Brief summary

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

Detailed 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.

Interventions

DRUGrosuvastatin

10mg tablets, once daily in three months

DRUGPlacebo

tablet, once daily, three months

Sponsors

University Hospital, Akershus
Lead SponsorOTHER
Oslo University Hospital
CollaboratorOTHER
AstraZeneca
CollaboratorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
40 Years to 70 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frame
Mean SUV of large arteries3 months

Secondary

MeasureTime frame
Peripheral endothelial function (pulse wave amplitude)3 months
Circulatory proinflammatory markers3 months
Heart rate variability3 months
Depressive symptoms3 months

Countries

Norway

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026