Searching for Early Biomarkers of Long-term Hepatic, Metabolic and Endothelial Dysfunction in Non-affective Psychosis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-02-12

Study Completion Date

2020-12-31

Brief Summary

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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.

Detailed Description

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Schizophrenia is a severe brain disorder with an excess mortality and reduced life expectancy. It has been proposed that around 60% of this excess mortality is due to physical pathology, mostly cardio-metabolic disorders. In addition to the deleterious effects of hypercaloric diet and sedentary lifestyle, the use of antipsychotic medication has itself a significant effect on metabolism. The metabolic disturbances described related to antipsychotic exposure include weight gain and obesity, dyslipemia, and insulin-resistance or new onset diabetes mellitus, representing cardio-metabolic risk factors leading to cardio-vascular events at the long-run. Some of these metabolic disturbances have been described as relevant factors for non-alcoholic fatty liver disease (NAFLD) development. NAFLD is accepted to be the hepatic component of the metabolic syndrome, and it has been described as an independent cardiovascular risk factor. A recent study by our group found a significant increase in the prevalence of hepatic steatosis after 3 years of antipsychotic treatment in a sample of patients with psychosis. Other studies proposed that there is a link between NAFLD and severe cardio-vascular disease that may be early predicted through peripheral microvascular system signs (endothelial dysfunction). Interestingly, recent studies have shown the presence of endothelial dysfunction in psychosis, probably related to antipsychotic-exposure. In summary, the investigators consider of relevance the study of a possible interrelation between metabolic syndrome, NAFLD, and endothelial dysfunction, at long-term, and their probable correlation with antipsychotic exposure.

Based on the available scientific evidence, the investigators hypothesize that the long-term exposure to antipsychotic medication would be related to liver disease and endothelial dysfunction.

The research project would be implemented as part of a larger prospective longitudinal study on first episode non-affective psychosis, in the First Episode Psychosis Clinical Program (PAFIP). In particular, the project would be part of the "10 PAFIP study", in which those patients that had been included in the PAFIP program 10 years ago will be extensively evaluated (e.g.: clinical, neuroimaging, neuro-psychological, and metabolic evaluations) in order to analyse the long-term progress of the psychosis.

Steatosis and fibrosis indexes would be determined for 10-years time point. For those patients with scores predicting hepatic fibrosis, a full hepatic examination, including elastometry assessment (FibroScan®) with controlled attenuation parameter (CAP) and abdominal ultrasound would be carried out. Moreover, endothelial function would be examined, using EndoPAT2000® and carotid ultrasound evaluation, for those patients turning 10 years since their antipsychotic treatment was firstly prescribed.

Conditions

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Schizophrenia Psychosis Metabolic Syndrome

Keywords

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Biomarkers Hepatic dysfunction Metabolic dysfunction Endothelial dysfunction Antipsychotics Non-alcoholic fatty liver disease

Study Design

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Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Eligibility Criteria

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Inclusion Criteria

* 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.

Exclusion Criteria

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Benedicto Crespo-Facorro

Associate Professor of Psychiatry

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Javier Vázquez Bourgon

Role: PRINCIPAL_INVESTIGATOR

Instituto de Investigación Marqués de Valdecilla

Locations

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University Hospital Marqués de Valdecilla

Santander, Cantabria, Spain

Site Status

Countries

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Spain

References

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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.

Reference Type DERIVED

PMID: 34004383 (View on PubMed)

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.