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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Withdrawn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
University Hospital, Akershus
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Depression focused on measuring Inflammation, Atherosclerosis, Hydroxymethylglutaryl-CoA Reductase Inhibitors

Eligibility Criteria

40 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

First Posted
August 3, 2009
Last Updated
January 31, 2023
Sponsor
University Hospital, Akershus
Collaborators
Oslo University Hospital, AstraZeneca
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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Withdrawn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

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Depression and Cardiovascular Risk Markers: Effects of Rosuvastatin Therapy

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