Depression and Cardiovascular Risk Markers: Effects of Rosuvastatin Therapy (DECAMERONE)

University Hospital, Akershus

Status and phase: Withdrawn; Phase 2

Conditions: Depression

Treatments: Drug: rosuvastatin; Drug: Placebo

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00951132

AHUSPP0651

Details and patient eligibility

About

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

Full 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.

Sex: All

Ages: 40 to 70 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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0 participants in 2 patient groups, including a placebo group

2

Experimental group

Description:

Rosuvastatin

Treatment:

Drug: rosuvastatin

1

Placebo Comparator group

Description:

Placebo

Treatment:

Drug: Placebo