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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2009 by University Hospital, Akershus.
Recruitment status was  Recruiting
Sponsor:
Collaborators:
Oslo University Hospital
AstraZeneca
Information provided by:
University Hospital, Akershus
ClinicalTrials.gov Identifier:
NCT00951132
First received: August 3, 2009
Last updated: September 8, 2009
Last verified: September 2009
History of Changes
  Purpose

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


Condition Intervention Phase
Depression
 Drug: rosuvastatin
Drug: Placebo
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Depression and Cardiovascular Risk Markers: Effects of Rosuvastatin Therapy

Resource links provided by NLM:

MedlinePlus related topics: Depression Statins
U.S. FDA Resources

Further study details as provided by University Hospital, Akershus:

Primary Outcome Measures:
  • Mean SUV of large arteries [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Peripheral endothelial function (pulse wave amplitude) [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • Circulatory proinflammatory markers [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • Heart rate variability [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • Depressive symptoms [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 40
Study Start Date: September 2009
Estimated Study Completion Date: December 2010
Estimated Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 2
Rosuvastatin
 Drug: rosuvastatin
10mg tablets, once daily in three months
Placebo Comparator: 1
Placebo
 Drug: Placebo
tablet, once daily, three months

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.

  Eligibility

Ages Eligible for Study:   40 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00951132

Contacts
Contact: Gunnar Einvik, MD 41104542 ext +47 gunnar.einvik@medisin.uio.no
Contact: Torbjorn Omland, PhD 67968856 ext +47 torbjorn.omland@medisin.uio.no

Locations
Norway
Akershus University Hospital Recruiting
Lorenskog, Akershus, Norway, 1478
Contact: Gunnar Einvik, MD     41104542 ext +47     gunnar.einvik@medisin.uio.no    
Sponsors and Collaborators
University Hospital, Akershus
Oslo University Hospital
AstraZeneca
Investigators
Principal Investigator: Torbjorn Omland, PhD University Hospital, Akershus
  More Information

No publications provided

Responsible Party: Professor Torbjorn Omland, Akershus University Hospital
ClinicalTrials.gov Identifier: NCT00951132     History of Changes
Other Study ID Numbers: AHUSPP0651
Study First Received: August 3, 2009
Last Updated: September 8, 2009
Health Authority: Norway: Norwegian Medicines Agency
Norway: Data Protection Authority

Keywords provided by University Hospital, Akershus:
Inflammation
Atherosclerosis
Hydroxymethylglutaryl-CoA Reductase Inhibitors

Additional relevant MeSH terms:
Depression
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Rosuvastatin
Anticholesteremic Agents
 Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Enzyme Inhibitors
Lipid Regulating Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 23, 2013