Psychiatric IllnessLIVERSPINNCT05213442
Liver Status in Psychiatric Inpatients
A study testing To estimate the prevalence rates of liver disease in psychiatric inpatients and to explore factors associated with the existence of liver disease. in people with Psychiatric Illness, run by Hôpital le Vinatier at 1 site in France.
Trial summary
Adults hospitalized in psychiatry have an increased frequency of somatic disorders, in particular various liver diseases (viral hepatitis, non-alcohol related liver steatosis, alcohol related liver disease). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Psychiatric Illness
- What is being tested?
- To estimate the prevalence rates of liver disease in psychiatric inpatients and to explore factors associated with the existence of liver disease.
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 450 participants
- Where
- 1 siteFrance
- Study dates
- 6 Apr 2022to 15 Dec 2023
- Phase
- Interventional
- 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
Who may be able to join
- Age >18 years old
- Social insurance
- Current hospitalization in any psychiatric unit of the participating center
- Adult or legal representative who has given written and informed consent to participate in the study. By default, the oral consent of the adult will be obtained (as well as the written consent of the legal representative)
- Information given to the curator(for people under curatorship)
Who cannot join
- - Clinical state of the patient which do not allow the collection of study data (according to the investigator)
Trial locations and contacts
1 site in 1 country.
France1 site
Centre Hospitalier Le Vinatier
Bron, Auvergne-Rhône-Alpes, 69678 cedex
About this study
Adults hospitalized in psychiatry have an increased frequency of somatic disorders, in particular various liver diseases (viral hepatitis, non-alcohol related liver steatosis, alcohol related liver disease).
The evaluation of these liver disorders in psychiatric inpatients remains very little explored in France, contributing to the poor overall medical status of psychiatric patients.
The LIVERSPIN study aims to estimate the prevalence rates of liver pathologies in psychiatric inpatients and to explore the factors associated with the existence of a liver pathology
Read the detailed description
The LIVERSPIN study aims to estimate the prevalence rates of liver disease in psychiatric inpatients and to explore factors associated with the existence of liver disease.
All hospitalized patients can potentially be recruited. They will benefit from the usual clinical and paraclinical examinations as part of their hospitalization diagnostic work-up. For the determination of biological analyses, a blood sample will be taken following inclusion as well as a Fibroscan examination.
- Conditions
- Psychiatric Illness
- Being tested
- To estimate the prevalence rates of liver disease in psychiatric inpatients and to explore factors associated with the existence of liver disease.
- Medical subject headings
- Mental Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
To estimate the prevalence rates of liver disease in psychiatric inpatients and to explore factors associated with the existence of liver disease.Diagnostic test
Patients will receive the usual clinical and paraclinical examinations as part of their hospitalization diagnostic workup. For the biological analyses, a blood sample will be taken following inclusion as well as a Fibroscan examination.
Data will be collected from the patient, or if necessary from the health care team, using the medical record (interview and/or self-questionnaires).
| Study group | Role | What they receive |
|---|---|---|
| All inpatients in Vinatier psychiatric Hospital | Other | All hospitalized patients can potentially be recruited. They will benefit from the usual clinical and paraclinical examinations as part of their hospitalization diagnostic work-up. For the determination of biological analyses, a blood sample will be taken following inclusion as well as a Fibroscan examination. Receives: Diagnostic Test: To estimate the prevalence rates of liver disease in psychiatric inpatients and to explore factors associated with the existence of liver disease. |
What is being measured
The primary outcome is the main question the study is designed to answer.
HCV diagnosis
HCV diagnosis defined by positive HCV antibodies in blood
Measured: At inclusion
Secondary outcomes (4)
HBV diagnosis
HBV diagnosis defined by positive HBsAg in blood
Measured: At inclusion
HIV diagnosis
HIV diagnosis defined by positive anti-HIV1 or anti-HIV2 antibodies in blood
Measured: At inclusion
Suspicion of NAFLD
Suspicion of NAFLD on FIB-4 and the interrogation
Measured: At inclusion
Suspicion of alcoholic liver disease
Suspicion of alcoholic liver disease on FIB-4 and the interrogation
Measured: At inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2022
- Study start6 Apr 2022
- Primary completion15 Dec 2023
- Study completion15 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Psychiatric IllnessStudies of the same condition, open and under way.
- More trials run by Hôpital le VinatierThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Monocentric, non randomized, non comparative cross-sectional study
- Masking
- None (open label)
- Enrolment
- 450 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hôpital le Vinatier
- Sponsor type
- University, hospital or other
- Collaborators
- Hospices Civils de Lyon
- Responsible party
- Sponsor
- Investigators
- Benjamin ROLLAND, MD, PhD, Principal investigator, CH LE VINATIER
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05213442
- Sponsor's protocol ID
- 2021-A02796-35
- Acronym
- LIVERSPIN
- Status last verified
- Feb 2024
- First submitted
- 26 Jan 2022
- Last updated
- 14 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Liver Status in Psychiatric Inpatients
- ClinicalTrials.gov ID
- NCT05213442
- Acronym / sponsor ID
- LIVERSPIN / 2021-A02796-35
- Conditions
- Psychiatric Illness
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 450 participants (actual)
- Lead sponsor
- Hôpital le VinatierUniversity, hospital or other
- Collaborators
- Hospices Civils de Lyon
- Study start
- 6 Apr 2022 (actual)
- Primary completion
- 15 Dec 2023 (actual)
- Study completion
- 15 Dec 2023 (actual)
- First posted
- 28 Jan 2022 (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.
Adults hospitalized in psychiatry have an increased frequency of somatic disorders, in particular various liver diseases (viral hepatitis, non-alcohol related liver steatosis, alcohol related liver disease).
The evaluation of these liver disorders in psychiatric inpatients remains very little explored in France, contributing to the poor overall medical status of psychiatric patients.
The LIVERSPIN study aims to estimate the prevalence rates of liver pathologies in psychiatric inpatients and to explore the factors associated with the existence of a liver pathology
Detailed description
The LIVERSPIN study aims to estimate the prevalence rates of liver disease in psychiatric inpatients and to explore factors associated with the existence of liver disease.
All hospitalized patients can potentially be recruited. They will benefit from the usual clinical and paraclinical examinations as part of their hospitalization diagnostic work-up. For the determination of biological analyses, a blood sample will be taken following inclusion as well as a Fibroscan examination.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Monocentric, non randomized, non comparative cross-sectional study
| Arm | Type | Receives |
|---|---|---|
| All inpatients in Vinatier psychiatric Hospital | Other | Diagnostic Test: To estimate the prevalence rates of liver disease in psychiatric inpatients and to explore factors associated with the existence of liver disease.All hospitalized patients can potentially be recruited. They will benefit from the usual clinical and paraclinical examinations as part of their hospitalization diagnostic work-up. For the determination of biological analyses, a blood sample will be taken following inclusion as well as a Fibroscan examination. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age >18 years old
- Social insurance
- Current hospitalization in any psychiatric unit of the participating center
- Adult or legal representative who has given written and informed consent to participate in the study. By default, the oral consent of the adult will be obtained (as well as the written consent of the legal representative)
- Information given to the curator(for people under curatorship)
Key exclusion criteria (1 listed)
- - Clinical state of the patient which do not allow the collection of study data (according to the investigator)
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 |
|---|---|---|
| To estimate the prevalence rates of liver disease in psychiatric inpatients and to explore factors associated with the existence of liver disease.Patients will receive the usual clinical and paraclinical examinations as part of their hospitalization diagnostic workup. For the biological analyses, a blood sample will be taken following inclusion as well as a Fibroscan examination. Data will be collected from the patient, or if necessary from the health care team, using the medical record (interview and/or self-questionnaires). | Diagnostic test | All inpatients in Vinatier psychiatric Hospital |
Primary outcome
HCV diagnosis
Time frame: At inclusion
HCV diagnosis defined by positive HCV antibodies in blood
4 secondary outcomes
HBV diagnosis
Time frame: At inclusion
HIV diagnosis
Time frame: At inclusion
Suspicion of NAFLD
Time frame: At inclusion
Suspicion of alcoholic liver disease
Time frame: At inclusion
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 14 Feb 2024.
- Individual participant dataSharing planned: No
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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.
Benjamin ROLLAND, MD, PhD principal investigator
CH LE VINATIER
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing To estimate the prevalence rates of liver disease in psychiatric inpatients and to explore factors associated with the existence of liver disease. in people with Psychiatric Illness, run by Hôpital le Vinatier 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 5 inclusion and 1 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 14 Feb 2024. 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?
HCV diagnosis (time frame: At inclusion). 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 14 Feb 2024.