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.
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
- Conditions the study is for
- Severe Bipolar I Disorder (Diagnosis), Bipolar I Disorder, Most Recent Episode Mixed, in Remission, Depression Psychotic Feature
- 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.
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.
- Conditions
- Severe Bipolar I Disorder (Diagnosis), Bipolar I Disorder, Most Recent Episode Mixed, in Remission, Depression Psychotic Feature, Mood-Incongruent Delusion
- 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.
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.
- First posted28 Jul 2023
- Study start26 Oct 2017
- Primary completion8 Feb 2018
- Study completion12 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Severe Bipolar I Disorder (Diagnosis)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Esquirol
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Philippe Nubukpo, Centre Hospitalier Esquirol
- Investigators
- Philippe B NUBUKPO, PhD, Principal investigator, Centre Hospitalier Esquirol
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
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Screening for Severe Hepatic Fibrosis by FibroScan in a Population Presenting a Severe Psychiatric Disorder Under Treatment for at Least Two Years.
- ClinicalTrials.gov ID
- NCT05965232
- Acronym / sponsor ID
- FibroPsy / 2017-A01998-45
- Conditions
- Severe Bipolar I Disorder (Diagnosis), Bipolar I Disorder, Most Recent Episode Mixed, in Remission, Depression Psychotic Feature, Mood-Incongruent Delusion
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 385 participants (actual)
- Lead sponsor
- Centre Hospitalier EsquirolUniversity, hospital or other
- Study start
- 26 Oct 2017 (actual)
- Primary completion
- 8 Feb 2018 (actual)
- Study completion
- 12 Jul 2021 (actual)
- First posted
- 28 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- 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,
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (4 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FibroscanAlso: Blood samplePerforming 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. | Diagnostic test | – |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Philippe B NUBUKPO, PhD principal investigator
Centre Hospitalier Esquirol
1 site in 1 country: see every site and its status.
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.