Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT05965232 |
| Other study ID # |
2017-A01998-45 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
October 26, 2017 |
| Est. completion date |
July 12, 2021 |
Study information
| Verified date |
July 2023 |
| Source |
Centre Hospitalier Esquirol |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical 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. 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.
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.
