DepressionPhase 2DECAMERONENCT00951132
Depression and Cardiovascular Risk Markers: Effects of Rosuvastatin Therapy
A Phase 2 study testing rosuvastatin in people with Depression, run by University Hospital, Akershus at 1 site in Norway.
Trial summary
The purpose of this study is to investigate whether rosuvastatin decreases measures of inflammation in depressive patients. Read more about this study
- Who is it for?
- Ages 40 to 70 years
- Conditions the study is for
- Depression
- What is being tested?
- rosuvastatin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteNorway
- Study dates
- Sep 2009to Dec 2013
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Persisting self-reported depressive symptoms > 5 weeks
- Indications of aortic atherosclerosis on PET/CT
Who cannot join
- Clinical indication of statin use.
- Contraindication of statins, or of PET/CT and MRI.
- Established cardiovascular disease.
- Bipolar disorder og comorbid psychosis.
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to investigate whether rosuvastatin decreases measures of inflammation in depressive patients.
Read the 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.
- Conditions
- Depression
- Being tested
- rosuvastatin, Placebo
- Keywords
- Inflammation, Atherosclerosis, Hydroxymethylglutaryl-CoA Reductase Inhibitors
- Medical subject headings
- Depression, Inflammation, Atherosclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
rosuvastatinDrug
10mg tablets, once daily in three months
PlaceboDrug
tablet, once daily, three months
| Study group | Role | What they receive |
|---|---|---|
| 2 | Experimental | Rosuvastatin Receives: Drug: rosuvastatin |
| 1 | Placebo comparator | Placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean SUV of large arteries
Measured: 3 months
Secondary outcomes (4)
Peripheral endothelial function (pulse wave amplitude)
Measured: 3 months
Circulatory proinflammatory markers
Measured: 3 months
Heart rate variability
Measured: 3 months
Depressive symptoms
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2009 (estimated)
- Study startSep 2009
- Primary completionDec 2012
- Study completionDec 2013
Why it stopped: Failure to include patients
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DepressionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Akershus
- Sponsor type
- University, hospital or other
- Collaborators
- Oslo University Hospital, AstraZeneca
- Responsible party
- Principal investigator, Torbjorn Omland, University Hospital, Akershus
- Investigators
- Torbjorn Omland, PhD, Principal investigator, University Hospital, Akershus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00951132
- Sponsor's protocol ID
- AHUSPP0651
- Acronym
- DECAMERONE
- Status last verified
- Jan 2023
- First submitted
- 3 Aug 2009
- Last updated
- 2 Feb 2023
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Depression and Cardiovascular Risk Markers: Effects of Rosuvastatin Therapy
- ClinicalTrials.gov ID
- NCT00951132
- Acronym / sponsor ID
- DECAMERONE / AHUSPP0651
- Conditions
- Depression
- Keywords
- Inflammation, Atherosclerosis, Hydroxymethylglutaryl-CoA Reductase Inhibitors
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Failure to include patients
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University Hospital, AkershusUniversity, hospital or other
- Collaborators
- Oslo University Hospital, AstraZeneca
- Study start
- Sep 2009
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 4 Aug 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 2 | Experimental | Drug: rosuvastatinRosuvastatin |
| 1 | Placebo comparator | Drug: PlaceboPlacebo |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Persisting self-reported depressive symptoms > 5 weeks
- Indications of aortic atherosclerosis on PET/CT
Key exclusion criteria (4 listed)
- Clinical indication of statin use.
- Contraindication of statins, or of PET/CT and MRI.
- Established cardiovascular disease.
- Bipolar disorder og comorbid psychosis.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| rosuvastatin10mg tablets, once daily in three months | Drug | 2 |
| Placebotablet, once daily, three months | Drug | 1 |
Primary outcome
Mean SUV of large arteries
Time frame: 3 months
4 secondary outcomes
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
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Torbjorn Omland, PhD principal investigator
University Hospital, Akershus
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing rosuvastatin in people with Depression, run by University Hospital, Akershus at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 2 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean SUV of large arteries (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Feb 2023.