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

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ClinicalTrials.gov Identifier: NCT03481465
Recruitment Status : Enrolling by invitation
First Posted : March 29, 2018
Last Update Posted : December 16, 2020
Sponsor:
Collaborators:
Instituto de Investigación Marqués de Valdecilla
Consorcio Centro de Investigación Biomédica en Red, M.P.
Information provided by (Responsible Party):
Benedicto Crespo-Facorro, Fundación Marques de Valdecilla

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.

Condition or disease
Schizophrenia Psychosis Metabolic Syndrome

Detailed 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.

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Study Type : Observational
Estimated Enrollment : 200 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Searching for Early Biomarkers of Long-term Hepatic, Metabolic and Endothelial Dysfunction in Non-affective Psychosis. A 10-year Follow-up Study
Actual Study Start Date : February 12, 2018
Actual Primary Completion Date : December 31, 2019
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. The incidence of Non-Alcoholic Fatty Liver Disease (NAFLD) diagnosed by transient elastography (FibroScan®) by spirometry. [ Time Frame: 10 years ]

Secondary Outcome Measures :
  1. The presence of endothelial dysfunction measured by EndoPAT2000®. [ Time Frame: 10 years ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-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).
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03481465


Locations
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Spain
University Hospital Marqués de Valdecilla
Santander, Cantabria, Spain, 39008
Sponsors and Collaborators
Fundación Marques de Valdecilla
Instituto de Investigación Marqués de Valdecilla
Consorcio Centro de Investigación Biomédica en Red, M.P.
Investigators
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Principal Investigator: Javier Vázquez Bourgon Instituto de Investigación Marqués de Valdecilla
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Benedicto Crespo-Facorro, Associate Professor of Psychiatry, Fundación Marques de Valdecilla
ClinicalTrials.gov Identifier: NCT03481465    
Other Study ID Numbers: HEP_10PAFIP
First Posted: March 29, 2018    Key Record Dates
Last Update Posted: December 16, 2020
Last Verified: December 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Benedicto Crespo-Facorro, Fundación Marques de Valdecilla:
Biomarkers
Hepatic dysfunction
Metabolic dysfunction
Endothelial dysfunction
Antipsychotics
Non-alcoholic fatty liver disease
Additional relevant MeSH terms:
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Metabolic Syndrome
Schizophrenia
Psychotic Disorders
Mental Disorders
Schizophrenia Spectrum and Other Psychotic Disorders
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases