FIbrosis and Steatosis in Patients With Psychiatric Illness

NCT05965232 | Completed DMC

• 1 other identifier: 2017-A01998-45
• Study Type: observational
• Target: 385
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Severe Bipolar I Disorder (Diagnosis); Bipolar I Disorder, Most Recent Episode Mixed, in Remission; Depression Psychotic Feature; Mood-Incongruent Delusion

Outcome Measures

Primary Outcomes (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.

  one day

Interventions

Fibroscan DIAGNOSTIC_TEST

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.

Also known as: Blood sample

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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,

You may qualify if:

• 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.

You may not qualify if:

• Short-term life-threatening conditions
• No antipsychotic or antidepressant treatment
• Anti-viral treatment demonstrating infection with hepatitis viruses or the HIV virus (or known positive HIV serology)

Sponsors & Collaborators

• Centre Hospitalier Esquirol: lead

Study Sites (1)

Centre Hospitalier Esquirol

Limoges, 87025, France

Location

Biospecimen

Retention: SAMPLES WITH DNA

1 dry tube to obtain serum (7 mL) and one heparinized tube for whole blood (7 mL) will be collected

MeSH Terms

Conditions

Disease

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Philippe B NUBUKPO, PhD

  Centre Hospitalier Esquirol

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: July 20, 2023
• First Posted: July 28, 2023
• Study Start: October 26, 2017
• Primary Completion: February 8, 2018
• Study Completion: July 12, 2021
• Last Updated: July 28, 2023

Record last verified: 2023-07

Locations

FR (1)