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Severe Bipolar I Disorder (Diagnosis)FibroPsyNCT05965232

FIbrosis and Steatosis in Patients With Psychiatric Illness

An observational study of Severe Bipolar I Disorder (Diagnosis) and Bipolar I Disorder, Most Recent Episode Mixed, in Remission, run by Centre Hospitalier Esquirol at 1 site in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Fibroscan
How many people
385 participants
Where
1 siteFrance
Study dates
26 Oct 2017to 12 Jul 2021
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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,

Who may be able to join

  • 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.

Who cannot join

  • 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)

Trial locations and contacts

1 site in 1 country.

France1 site
  • Centre Hospitalier Esquirol

    Limoges, 87025

Other trials in France

About this study

Official title: 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.

Read the 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.

Being tested
Fibroscan
Medical subject headings
Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • FibroscanDiagnostic test

    Also called Blood sample

    Performing FibroScan :

    The patient is positioned supine, with the right arm in maximum abduction to clear the intercostal spaces.The measurement itself is performed on the right lobe of the liver via the intercostal (intersection of the mid-axillary line and the xiphoid process) using a dedicated probe (3.5 MHz) after application of a conduction gel to the skin. FibroScan® examinations are carried out by personnel trained in the use of the device.This training is specific and validated by the device's manufacturer manufacturer, EchosensTM (Paris). Ten valid measurements at the same measurement point in the right liver must be be performed, with an interquartile range/median ratio ≤ 30 (required only if the elastometry value is > 7.1 KPa.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    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.

    Measured: one day

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Jul 2023
  2. Study start26 Oct 2017
  3. Primary completion8 Feb 2018
  4. Study completion12 Jul 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
385 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05965232
Sponsor's protocol ID
2017-A01998-45
Acronym
FibroPsy
Status last verified
Jul 2023
First submitted
20 Jul 2023
Last updated
28 Jul 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

An observational study of Severe Bipolar I Disorder (Diagnosis) and Bipolar I Disorder, Most Recent Episode Mixed, in Remission, run by Centre Hospitalier Esquirol at 1 site in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jul 2023.

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