Depression and Cardiovascular Risk Markers: Effects of Ro... | NCT00951132

Studies
Depression and Cardiovascular Risk Markers: Effects of Rosuvastatin Therapy

NCT00951132

Sponsor

University Hospital, Akershus

Status

Withdrawn

Last Update Posted

Feb 2, 2023Actual

Enrollment

0Actual

Phase

Phase 2

Conditions

Depression

Interventions

rosuvastatin
Placebo

Countries

Norway

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2023

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Failure to include patients

Expanded Access Info

Start Date

Sep 2009

Primary Completion Date

Dec 2012Actual

Completion Date

Dec 2013Actual

First Submitted Date

Aug 3, 2009

First Submission Date that Met QC Criteria

Aug 3, 2009

First Posted Date

Aug 4, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 31, 2023

Last Update Posted Date

Feb 2, 2023Actual

Name	Class
Oslo University Hospital	OTHER
AstraZeneca	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
2	Experimental	Rosuvastatin	Drug: rosuvastatin
1	Placebo Comparator	Placebo	Drug: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
rosuvastatin	Drug	10mg tablets, once daily in three months	2
Placebo

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Mean SUV of large arteries		3 months

Secondary Outcomes

Measure	Description	Time Frame
Peripheral endothelial function (pulse wave amplitude)		3 months
Circulatory proinflammatory markers		3 months
Heart rate variability

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

40 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Torbjorn Omland, PhD	University Hospital, Akershus	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Akershus University Hospital		Lorenskog	Akershus	1478	Norway

Condition Browse Module

MeSH Terms

ID	Term
D003863	Depression
D007249	Inflammation
D050197	Atherosclerosis

Ancestor Terms

ID	Term
D001526	Behavioral Symptoms
D001519	Behavior
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000068718	Rosuvastatin Calcium

Ancestor Terms

ID	Term
D013449	Sulfonamides
D000577	Amides
D009930	Organic Chemicals
D005464	Fluorobenzenes

Browse Leaves

Not provided

Browse Branches

Not provided