NCT03481465

Brief Summary

This study aims to evaluate, at long-term, the occurrence of liver disease and cardio-vascular risk, in a sample of patients diagnosed with first episode of non-affective psychosis.

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
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2018

Typical duration for all trials

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

February 12, 2018

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

March 19, 2018

Completed
10 days until next milestone

First Posted

Study publicly available on registry

March 29, 2018

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2019

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2020

Completed
Last Updated

December 16, 2020

Status Verified

December 1, 2020

Enrollment Period

1.9 years

First QC Date

March 19, 2018

Last Update Submit

December 14, 2020

Conditions

SchizophreniaPsychosisMetabolic Syndrome

Keywords

BiomarkersHepatic dysfunctionMetabolic dysfunctionEndothelial dysfunctionAntipsychoticsNon-alcoholic fatty liver disease

Outcome Measures

Primary Outcomes (1)

  • The incidence of Non-Alcoholic Fatty Liver Disease (NAFLD) diagnosed by transient elastography (FibroScan®) by spirometry.

    10 years

Secondary Outcomes (1)

  • The presence of endothelial dysfunction measured by EndoPAT2000®.

    10 years

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Individuals included in the Longitudinal Long-term Study of First Episode Psychosis Clinical Program (10-PAFIP) at the University Hospital Marqués de Valdecilla (Santander - Cantabria).

You may qualify if:

  • Patients followed in the First Episode Psychosis Clinical Program (PAFIP) from February 2001 to December 2007.
  • Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) criteria of brief psychotic disorder, schizophreniform disorder, schizophrenia or schizoaffective disorder.

You may not qualify if:

  • Meeting DSM-IV criteria for drug dependence.
  • Meeting DSM-IV criteria for mental retardation.
  • Having a history of neurological disease or head injury.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Marqués de Valdecilla

Santander, Cantabria, 39008, Spain

Location

Related Publications (2)

  • Mayoral-van Son J, Juncal-Ruiz M, Ortiz-Garcia de la Foz V, Vazquez-Bourgon J, Setien-Suero E, Tordesillas-Gutierrez D, Gomez-Revuelta M, Ayesa-Arriola R, Crespo-Facorro B; PAFIP Research Group. Long-term clinical and functional outcome after antipsychotic discontinuation in early phases of non-affective psychosis: Results from the PAFIP-10 cohort. Schizophr Res. 2021 Jun;232:28-30. doi: 10.1016/j.schres.2021.04.011. Epub 2021 May 16. No abstract available.

    PMID: 34004383DERIVED

  • Vazquez-Bourgon J, Ortiz-Garcia de la Foz V, Suarez-Pereira I, Iruzubieta P, Arias-Loste MT, Setien-Suero E, Ayesa-Arriola R, Gomez-Revuelta M, Crespo J, Crespo Facorro B. Cannabis consumption and non-alcoholic fatty liver disease. A three years longitudinal study in first episode non-affective psychosis patients. Prog Neuropsychopharmacol Biol Psychiatry. 2019 Dec 20;95:109677. doi: 10.1016/j.pnpbp.2019.109677. Epub 2019 Jun 20.

    PMID: 31228640DERIVED

MeSH Terms

Conditions

SchizophreniaPsychotic DisordersMetabolic SyndromeLiver DiseasesNon-alcoholic Fatty Liver Disease

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental DisordersInsulin ResistanceHyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesDigestive System DiseasesFatty Liver

Study Officials

  • Javier Vázquez Bourgon

    Instituto de Investigación Marqués de Valdecilla

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Psychiatry

Study Record Dates

First Submitted

March 19, 2018

First Posted

March 29, 2018

Study Start

February 12, 2018

Primary Completion

December 31, 2019

Study Completion

December 1, 2020

Last Updated

December 16, 2020

Record last verified: 2020-12

Data Sharing

IPD Sharing
Will not share

Locations

ES(1)