FIbrosis and Steatosis in Patients With Psychiatric Illness (FibroPsy)

July 20, 2023 updated by: Philippe Nubukpo, Centre Hospitalier Esquirol

Screening for Severe Hepatic Fibrosis by FibroScan in a Population Presenting a Severe Psychiatric Disorder Under Treatment for at Least Two Years.

Background: Severe psychiatric diseases (schizophrenia, bipolarity, depression, anxious syndrome) are often associated with a metabolic syndrome, including Non-Alcoholic Steato Hepatitis, probably misdiagnosed in patients with psychiatric illness. Furthermore, long-term exposition to substances like alcohol or to one or more psychotropic treatments may involve liver detoxification role. Thanks to liver stiffness, based on FibroScan®, and CAP (controlled attenuation parameter), we wanted to study prevalence of severe fibrosis and steatosis in this population.

Material & Methods: Prospective study of 385 subjects hospitalised in a psychiatric hospital for schizophrenia, bipolar disorder, depression or anxiety-depression disorder and receiving psychotropic treatment for at least 2 years, for whom a FibroScan®, a blood test and a record of clinical data were carried out, after information and informed consent.

Benefits expected : This study should show an expected excess risk of fibrosis. FibroScan® in this population and determine the risk factors more associated risk factors. Generalized or targeted screening for identified risk factors in this population could help optimize in this population could help optimize the choice and dosage of psychotropic of psychotropic drugs, and above all, help to guide the strategy of hepatic and prevention strategy.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Patients with psychiatric illness are often exposed to an increase risk of mortality compared to the general population: a reduction of life expectancy between 7 and 24 years has been described . Somatic illnesses explain 60% of this excess of mortality, particularly cardiovascular diseases . Notably, patients with chronic psychiatric disorders, such as depression, bipolar disorders or schizophrenia are more frequently exposed to metabolic syndrome. A recent meta-analysis showed that patients with severe mental illness had a RR of 1.58 (1.35-1.86) of developing metabolic syndrome.

Steatosis, or fat excess in hepatocytes defines NAFLD (non-alcoholic fatty liver disease). NAFLD is a spectrum of liver illnesses associated with metabolic syndrome. Within NAFLD, NASH (non-alcoholic steatohepatitis) occurs in about 5 % of the cases, liver inflammation and/or fibrosis being associated to steatosis: Survival is then impaired, notably with a specific risk of cirrhosis in 20% of the patients with NASH and 3 % of patients with NAFLD . Hepatocarcinoma is a complication of cirrhosis but it may be observed in the absence of cirrhosis in nearly 30% of the cases. Its prevalence is progressively increasing, from 20 to 27%. It will probably be the leading cause of liver transplantation in the next years Otherwise, patients with NAFLD are also exposed to non-liver related complications: cardiovascular risk is higher in this population and is the main risk of mortality.

Although NAFLD is a frequent disease, it is yet generally misdiagnosed today, essentially because of the lack of symptoms and of systematic screening. Furthermore, it is key to diagnose the evolutionary stage: pure NAFLD, NASH and stage of fibrosis. The liver biopsy remains the gold standard, despite its limitations linked to the sample variability and the differences in interpretation even between expert pathologists.

However, specific risks associated with this procedure, such as bleeding and even a marginal risk of death have been described. Furthermore, liver biopsy is costly. All these arguments explain the difficulty to apply this invasive strategy in screening in the general population. That's why different methods, based on non-invasive tests, were developed to diagnose fibrosis - the main prognostic factor - and more recently in a more preliminary way to assess steatosis and inflammation. Two main methods are used to evaluate fibrosis stage: serum biomarkers and liver stiffness. Serum biomarkers are non-parametric (for example NAFLD fibrosis score, Fib4, Forns score and more recently, eLIFT.) or parametric (for example FibroTest, FibroMeter.). Liver stiffness is mainly assessed by FibroScan: it is easily available, and reproducible. It was largely validated in different liver diseases, including NAFLD. Steatosis is simultaneously evaluated, thanks to CAP (controlled attenuation parameter.). Strategies based on the associations of different markers have been evaluated to increase sensibility and specificity of each method taken alone to assess fibrosis. Specific combinations of elastometry and biomarkers have emerged, such as FibroMeterVCTE, and FAST.

In the psychiatric field, NAFLD screening may be important to help to identify patients at liver risk and also at a potential metabolic risk especially since a specific management is available.

Even if the association between NAFLD and psychiatric disorders has been described, its exact prevalence and impact are not well identified.

This is why we aimed to explore the prevalence of liver fibrosis and steatosis in patients with chronic psychiatric illnesses. We led a prospective descriptive single-center study in the Esquirol psychiatric hospital in Limoges.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
385

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Limoges, France, 87025
        • Centre Hospitalier Esquirol

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Subjects hospitalised in a psychiatric hospital for schizophrenia, bipolar disorder, depression or anxiety-depression disorder and receiving psychotropic treatment for at least 2 years,

Description

Inclusion Criteria:

  • Patients with a severe psychiatric disorder (psychotic disorder, mood disorder, anxiety or anxiety disorder), and under psychotropic treatment (neuroleptic and/or antidepressant) for at least two years.

and/or antidepressant) for at least two years, and hospitalized in units treating these disorders in the investigating centers.

- Subjects or their legal representatives who have given informed consent, with social insurance, aged over 18 years of age.

Exclusion Criteria:

  • Short-term life-threatening conditions
  • Liver disease already diagnosed at inclusion: cancer, cirrhosis, chronic or acute or acute liver disease
  • No antipsychotic or antidepressant treatment
  • Anti-viral treatment demonstrating infection with hepatitis viruses or the HIV virus (or known positive HIV serology)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Severe fibrosis assessed by FibroScan® in the population of subjects with a severe psychiatric disorder who have been on psychotropic medication for more than than two years
Time Frame: one day
The cut-off selected for FibroScan® ≥ 8.7 kPa is that published for the diagnosis of severe fibrosis. It is considered clinically relevant associated with a poorer prognosis.
one day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Centre Hospitalier Esquirol

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Philippe B NUBUKPO, PhD, Centre Hospitalier Esquirol

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 26, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 8, 2018

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 12, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 20, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 20, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 28, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 28, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 20, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2017-A01998-45

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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