We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified September 2009 by University Hospital, Akershus.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00951132
First Posted: August 4, 2009
Last Update Posted: September 9, 2009
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.
Collaborators:
Oslo University Hospital
AstraZeneca
Information provided by:
University Hospital, Akershus
  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
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Depression and Cardiovascular Risk Markers: Effects of Rosuvastatin Therapy

Resource links provided by NLM:


Further study details as provided by University Hospital, Akershus:

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

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

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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.
  Contacts and Locations
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
  More Information

Responsible Party: Professor Torbjorn Omland, Akershus University Hospital
ClinicalTrials.gov Identifier: NCT00951132     History of Changes
Other Study ID Numbers: AHUSPP0651
First Submitted: August 3, 2009
First Posted: August 4, 2009
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