NCT02885792

Brief Summary

Schizophrenia is a severe mental illness associated with excess mortality and affecting nearly 1% of the population. The average life expectancy for patients diagnosed with schizophrenia has been 55-60 years through the last generations in Denmark, while the general population has over the same period of time experienced an increase in life expectancy. As a result, the standardized mortality rate for patients with schizophrenia has increased markedly over the last three decades and is currently a major public health concern. Causes of death are mainly cardiovascular disease and patients diagnosed with schizophrenia has a relative risk of cardiovascular disease that is about 2-fold higher than the general population.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
300

participants targeted

Target at P75+ for not_applicable schizophrenia

Timeline
Completed

Started Sep 2015

Longer than P75 for not_applicable schizophrenia

Geographic Reach
1 country

1 active site

Status
unknown

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

Study Start

First participant enrolled

September 1, 2015

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

July 1, 2016

Completed
2 months until next milestone

First Posted

Study publicly available on registry

September 1, 2016

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2019

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2020

Completed
Last Updated

January 31, 2017

Status Verified

January 1, 2017

Enrollment Period

4 years

First QC Date

July 1, 2016

Last Update Submit

January 30, 2017

Conditions

SchizophreniaCardiovascular Disease

Keywords

SchizophreniaCardiovascular diseasePremature mortalityArteriosclerosisRisk factorInterventionTreatmentSomatic morbidity

Outcome Measures

Primary Outcomes (1)

  • CT coronary angiography - a quantitative clinical measurement

    CT coronary angiography is a non-invasive procedure that uses simple CT-scan without contrast to measure coronary calcifications

    6 years

Secondary Outcomes (16)

  • Existing psychiatric and somatic diagnosis and treatment - Self-report questionnaire

    6 years

  • Charlson Co-morbidity index - Self-report questionnaire

    6 years

  • Lubben Social Network Scale-6 (LSNS-6) - Self-report questionnaire

    6 years

  • Global Assessment of Functioning (GAF) - Clinical evaluation

    6 years

  • Positive and Negative Syndrome Scale (PANNS) - Clinical psychiatric evaluation

    6 years

  • +11 more secondary outcomes

Study Arms (2)

Debuting and chronic schizophrenia

EXPERIMENTAL

ILLNESS HISTORY: * Existing psychiatric and somatic diagnosis and treatment * Charlson co-morbidity MEASURE OF SOCIAL CONDITIONS \- For example Lubben Social Network Scale-6 and Brief Trauma Questionnaire. MEASURE OF PSYCHIATRIC CONDITION:: * Positive and Negative Syndrome Scale (PANSS) * Clinical Global Impression Scale (CGI) * Columbia Suicide Severity Rating Scale (C-SSRS) * Beck Cognitive Insight Scale * Birchwood Insight Scale CARDIOVASCULAR MEASUREMENT: CT Coronary angiography (CT-CAG) * Echocardiography * Heart rate variability (HRV) * Pulmonary function test (PFT) * Toe blood pressure (TBP) * Blood test * Body composition analysis * CT scan of upper abdomen * Cardiovascular magnetic resonance imaging (CMR) * Adipose tissue biopsy

Other: Illness historyOther: Measure of social conditionsOther: Measure of psychiatric conditionProcedure: Cardiovascular measurement

Matched controls

ACTIVE COMPARATOR

CARDIOVASCULAR MEASUREMENT: * CT Coronary angiography (CT-CAG) * Echocardiography * Heart rate variability (HRV) * Pulmonary function test (PFT) * Toe blood pressure (TBP) * Blood test * Body composition analysis * CT scan of upper abdomen * Cardiovascular magnetic resonance imaging (CMR) * Adipose tissue biopsy

Procedure: Cardiovascular measurement

Interventions

Illness historyOTHER

Existing psychiatric and somatic diagnosis and treatment. Charlson co-morbidity Index.

Debuting and chronic schizophrenia
Measure of social conditionsOTHER

A self-report questionnaire measuring social isolation, including relations to family and friends.

Debuting and chronic schizophrenia
Measure of psychiatric conditionOTHER

This method measures symptom severity, therapeutic response and general improvement, suicidal ideation, cognitive insight and awareness of illness and need for treatment and the ability to relabel symptoms.

Debuting and chronic schizophrenia
Cardiovascular measurementPROCEDURE

This procedure is used to detect early identification of cardiovascular disease progression.

Debuting and chronic schizophreniaMatched controls

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Participants with a diagnosis of F20 schizophrenia.
  • Informed statement of consent
  • Age \> 18

You may not qualify if:

  • Incompetency to create stabile relation or make agreements
  • Pregnancy and also breastfeeding women
  • Participants with severe claustrophobia
  • Participants with lack of ability to cooperate with the planned study program.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Aalborg University Hospital, Psychiatric Hospital

Aalborg, DK-9000, Denmark

RECRUITING

Related Publications (2)

  • Jorgensen LR, Hegtmann CL, Straszek SPV, Hoyer C, Polcwiartek C, Petersen LJ, Dalgaard MK, Jensen SE, Nielsen RE. Peripheral artery disease in patients with schizophrenia as compared to controls. BMC Cardiovasc Disord. 2023 Mar 8;23(1):126. doi: 10.1186/s12872-023-03143-9.

    PMID: 36890440DERIVED

  • Trab T, Attar R, Jensen SE, Grontved S, Frokjaer JB, Polcwiartek C, Nielsen RE. Coronary artery calcium in patients with schizophrenia. BMC Psychiatry. 2021 Aug 23;21(1):422. doi: 10.1186/s12888-021-03412-x.

    PMID: 34425769DERIVED

MeSH Terms

Conditions

SchizophreniaCardiovascular DiseasesArteriosclerosis

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental DisordersArterial Occlusive DiseasesVascular Diseases

Study Officials

  • Svend E. Jensen, MD

    Aalborg University Hospital, Psychiatric Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jørgen Aagaard, MD

CONTACT

97643626joaa@rn.dk

Svend E. Jensen, MD

CONTACT

svend.eggert.jensen@rn.dk

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chief consultant, Professor, Dr.Med.Sci.

Study Record Dates

First Submitted

July 1, 2016

First Posted

September 1, 2016

Study Start

September 1, 2015

Primary Completion

September 1, 2019

Study Completion

September 1, 2020

Last Updated

January 31, 2017

Record last verified: 2017-01

Data Sharing

IPD Sharing
Will not share

Locations

DK(1)