Depression and Cardiovascular Risk Markers: Effects of Rosuvastatin Therapy (DECAMERONE)
Primary Purpose
Depression
Status
Withdrawn
Phase
Phase 2
Locations
Norway
Study Type
Interventional
Intervention
rosuvastatin
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Depression focused on measuring Inflammation, Atherosclerosis, Hydroxymethylglutaryl-CoA Reductase Inhibitors
Eligibility 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.
Sites / Locations
- Akershus University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
2
1
Arm Description
Rosuvastatin
Placebo
Outcomes
Primary Outcome Measures
Mean SUV of large arteries
Secondary Outcome Measures
Peripheral endothelial function (pulse wave amplitude)
Circulatory proinflammatory markers
Heart rate variability
Depressive symptoms
Full Information
NCT ID
NCT00951132
First Posted
August 3, 2009
Last Updated
January 31, 2023
Sponsor
University Hospital, Akershus
Collaborators
Oslo University Hospital, AstraZeneca
1. Study Identification
Unique Protocol Identification Number
NCT00951132
Brief Title
Depression and Cardiovascular Risk Markers: Effects of Rosuvastatin Therapy
Acronym
DECAMERONE
Official Title
Depression and Cardiovascular Risk Markers: Effects of Rosuvastatin Therapy
Study Type
Interventional
2. Study Status
Record Verification Date
January 2023
Overall Recruitment Status
Withdrawn
Why Stopped
Failure to include patients
Study Start Date
September 2009 (undefined)
Primary Completion Date
December 2012 (Actual)
Study Completion Date
December 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Hospital, Akershus
Collaborators
Oslo University Hospital, AstraZeneca
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of this study is to investigate whether rosuvastatin decreases measures of inflammation in depressive patients.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression
Keywords
Inflammation, Atherosclerosis, Hydroxymethylglutaryl-CoA Reductase Inhibitors
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
2
Arm Type
Experimental
Arm Description
Rosuvastatin
Arm Title
1
Arm Type
Placebo Comparator
Arm Description
Placebo
Intervention Type
Drug
Intervention Name(s)
rosuvastatin
Intervention Description
10mg tablets, once daily in three months
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
tablet, once daily, three months
Primary Outcome Measure Information:
Title
Mean SUV of large arteries
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Peripheral endothelial function (pulse wave amplitude)
Time Frame
3 months
Title
Circulatory proinflammatory markers
Time Frame
3 months
Title
Heart rate variability
Time Frame
3 months
Title
Depressive symptoms
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Torbjorn Omland, PhD
Organizational Affiliation
University Hospital, Akershus
Official's Role
Principal Investigator
Facility Information:
Facility Name
Akershus University Hospital
City
Lorenskog
State/Province
Akershus
ZIP/Postal Code
1478
Country
Norway
12. IPD Sharing Statement
Learn more about this trial
Depression and Cardiovascular Risk Markers: Effects of Rosuvastatin Therapy
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