Depression and Cardiovascular Risk Markers: Effects of Rosuvastatin Therapy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE2

Study Classification

INTERVENTIONAL

Study Start Date

2009-09-30

Study Completion Date

2013-12-31

Brief Summary

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

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Detailed Description

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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.

Conditions

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Depression

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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2

Rosuvastatin

Group Type EXPERIMENTAL

rosuvastatin

Intervention Type DRUG

10mg tablets, once daily in three months

1

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

tablet, once daily, three months

Interventions

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rosuvastatin

10mg tablets, once daily in three months

Intervention Type DRUG

Placebo

tablet, once daily, three months

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

40 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No