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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00951132
Recruitment Status : Unknown
Verified September 2009 by University Hospital, Akershus.
Recruitment status was:  Recruiting
First Posted : August 4, 2009
Last Update Posted : September 9, 2009
Oslo University Hospital
Information provided by:
University Hospital, Akershus

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

Condition or disease Intervention/treatment Phase
Depression Drug: rosuvastatin Drug: Placebo Phase 2

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  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Depression and Cardiovascular Risk Markers: Effects of Rosuvastatin Therapy
Study Start Date : September 2009
Estimated Primary Completion Date : December 2010
Estimated Study Completion Date : December 2010

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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

Primary Outcome Measures :
  1. Mean SUV of large arteries [ Time Frame: 3 months ]

Secondary Outcome Measures :
  1. Peripheral endothelial function (pulse wave amplitude) [ Time Frame: 3 months ]
  2. Circulatory proinflammatory markers [ Time Frame: 3 months ]
  3. Heart rate variability [ Time Frame: 3 months ]
  4. Depressive symptoms [ Time Frame: 3 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00951132

Contact: Gunnar Einvik, MD 41104542 ext +47
Contact: Torbjorn Omland, PhD 67968856 ext +47

Akershus University Hospital Recruiting
Lorenskog, Akershus, Norway, 1478
Contact: Gunnar Einvik, MD    41104542 ext +47   
Sponsors and Collaborators
University Hospital, Akershus
Oslo University Hospital
Principal Investigator: Torbjorn Omland, PhD University Hospital, Akershus

Responsible Party: Professor Torbjorn Omland, Akershus University Hospital Identifier: NCT00951132     History of Changes
Other Study ID Numbers: AHUSPP0651
First Posted: August 4, 2009    Key Record Dates
Last Update Posted: September 9, 2009
Last Verified: September 2009

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

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