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

January 31, 2023 updated by: Torbjorn Omland, University Hospital, Akershus
The purpose of this study is to investigate whether rosuvastatin decreases measures of inflammation in depressive patients.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Norway
    • Akershus
      • Lorenskog, Akershus, Norway, 1478
        • Akershus University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: 1
Placebo
Drug: Placebo
tablet, once daily, three months
Experimental: 2
Rosuvastatin
Drug: rosuvastatin
10mg tablets, once daily in three months

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Mean SUV of large arteries
Time Frame: 3 months
3 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Peripheral endothelial function (pulse wave amplitude)
Time Frame: 3 months
3 months
Circulatory proinflammatory markers
Time Frame: 3 months
3 months
Heart rate variability
Time Frame: 3 months
3 months
Depressive symptoms
Time Frame: 3 months
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Akershus

Collaborators

Oslo University Hospital
AstraZeneca

Investigators

  • Principal Investigator: Torbjorn Omland, PhD, University Hospital, Akershus

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2009

Primary Completion (Actual)

December 1, 2012

Study Completion (Actual)

December 1, 2013

Study Registration Dates

First Submitted

August 3, 2009

First Submitted That Met QC Criteria

August 3, 2009

First Posted (Estimate)

August 4, 2009

Study Record Updates

Last Update Posted (Actual)

February 2, 2023

Last Update Submitted That Met QC Criteria

January 31, 2023

Last Verified

January 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AHUSPP0651

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.

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