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

Schizophrenia Clinical Trial

Official title:

Searching for Early Biomarkers of Long-term Hepatic, Metabolic and Endothelial Dysfunction in Non-affective Psychosis. A 10-year Follow-up Study

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT03481465
• Other study ID #: HEP_10PAFIP
• Status: Enrolling by invitation
• Start date: February 12, 2018
• Est. completion date: December 2020

Study information

• Verified date: December 2020
• Source: Fundación Marques de Valdecilla
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 200
• Est. completion date: December 2020
• Est. primary completion date: December 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Mental Disorders
• Metabolic Syndrome
• Psychosis
• Psychotic Disorders
• Schizophrenia

Locations

Country	Name	City	State
Spain	University Hospital Marqués de Valdecilla	Santander	Cantabria

Sponsors (3)

Lead Sponsor	Collaborator
Fundación Marques de Valdecilla	Consorcio Centro de Investigación Biomédica en Red, M.P., Instituto de Investigación Marqués de Valdecilla

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The incidence of Non-Alcoholic Fatty Liver Disease (NAFLD) diagnosed by transient elastography (FibroScan®) by spirometry.		10 years
Secondary	The presence of endothelial dysfunction measured by EndoPAT2000®.		10 years