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

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ClinicalTrials.gov 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
Sponsor:
Collaborators:
Oslo University Hospital
AstraZeneca
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
Rosuvastatin
Drug: rosuvastatin
10mg tablets, once daily in three months
Placebo Comparator: 1
Placebo
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
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.

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 ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Professor Torbjorn Omland, Akershus University Hospital
ClinicalTrials.gov 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:
Inflammation
Atherosclerosis
Hydroxymethylglutaryl-CoA Reductase Inhibitors

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