NCT00951132

Brief Summary

The purpose of this study is to investigate whether rosuvastatin decreases measures of inflammation in depressive patients.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Sep 2009

Typical duration for phase_2 depression

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 3, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 4, 2009

Completed
28 days until next milestone

Study Start

First participant enrolled

September 1, 2009

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
Last Updated

February 2, 2023

Status Verified

January 1, 2023

Enrollment Period

3.3 years

First QC Date

August 3, 2009

Last Update Submit

January 31, 2023

Conditions

Depression

Keywords

InflammationAtherosclerosisHydroxymethylglutaryl-CoA Reductase Inhibitors

Outcome Measures

Primary Outcomes (1)

  • Mean SUV of large arteries

    3 months

Secondary Outcomes (4)

  • Peripheral endothelial function (pulse wave amplitude)

    3 months

  • Circulatory proinflammatory markers

    3 months

  • Heart rate variability

    3 months

  • Depressive symptoms

    3 months

Study Arms (2)

2

EXPERIMENTAL

Rosuvastatin

Drug: rosuvastatin

1

PLACEBO COMPARATOR

Placebo

Drug: Placebo

Interventions

rosuvastatinDRUG

10mg tablets, once daily in three months

2
PlaceboDRUG

tablet, once daily, three months

1

Eligibility Criteria

Age40 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Persisting self-reported depressive symptoms \> 5 weeks
  • Indications of aortic atherosclerosis on PET/CT

You may not qualify if:

  • Clinical indication of statin use.
  • Contraindication of statins, or of PET/CT and MRI.
  • Established cardiovascular disease.
  • Bipolar disorder og comorbid psychosis.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Akershus University Hospital

Lorenskog, Akershus, 1478, Norway

Location

MeSH Terms

Conditions

DepressionInflammationAtherosclerosis

Interventions

Rosuvastatin Calcium

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehaviorPathologic ProcessesPathological Conditions, Signs and SymptomsArteriosclerosisArterial Occlusive DiseasesVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

SulfonamidesAmidesOrganic ChemicalsFluorobenzenesHydrocarbons, FluorinatedHydrocarbons, HalogenatedHydrocarbonsSulfonesSulfur CompoundsPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Torbjorn Omland, PhD

    University Hospital, Akershus

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

August 3, 2009

First Posted

August 4, 2009

Study Start

September 1, 2009

Primary Completion

December 1, 2012

Study Completion

December 1, 2013

Last Updated

February 2, 2023

Record last verified: 2023-01

Locations

NO(1)