SchizophreniaNCT03481465
Searching for Early Biomarkers of Long-term Hepatic, Metabolic and Endothelial Dysfunction in Non-affective Psychosis
An observational study of Schizophrenia and Psychosis, run by Fundación Marques de Valdecilla at 1 site in Spain.
Trial summary
This study aims to evaluate, at long-term, the occurrence of liver disease and cardio-vascular risk, in a sample of patients diagnosed with first episode of non-affective psychosis. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Schizophrenia, Psychosis, Metabolic Syndrome
- How many people
- 200 participants
- Where
- 1 siteSpain
- Study dates
- 12 Feb 2018to Dec 2020
- 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 to 60 years
- All sexes
- No healthy volunteers
- Adult
Study population: Individuals included in the Longitudinal Long-term Study of First Episode Psychosis Clinical Program (10-PAFIP) at the University Hospital Marqués de Valdecilla (Santander - Cantabria).
Who may be able to join
- Patients followed in the First Episode Psychosis Clinical Program (PAFIP) from February 2001 to December 2007.
- Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) criteria of brief psychotic disorder, schizophreniform disorder, schizophrenia or schizoaffective disorder.
Who cannot join
- Meeting DSM-IV criteria for drug dependence.
- Meeting DSM-IV criteria for mental retardation.
- Having a history of neurological disease or head injury.
Trial locations and contacts
1 site in 1 country.
Spain1 site
University Hospital Marqués de Valdecilla
Santander, Cantabria, 39008
About this study
Official title: Searching for Early Biomarkers of Long-term Hepatic, Metabolic and Endothelial Dysfunction in Non-affective Psychosis. A 10-year Follow-up Study
This study aims to evaluate, at long-term, the occurrence of liver disease and cardio-vascular risk, in a sample of patients diagnosed with first episode of non-affective psychosis.
Read the detailed description
Schizophrenia is a severe brain disorder with an excess mortality and reduced life expectancy. It has been proposed that around 60% of this excess mortality is due to physical pathology, mostly cardio-metabolic disorders. In addition to the deleterious effects of hypercaloric diet and sedentary lifestyle, the use of antipsychotic medication has itself a significant effect on metabolism. The metabolic disturbances described related to antipsychotic exposure include weight gain and obesity, dyslipemia, and insulin-resistance or new onset diabetes mellitus, representing cardio-metabolic risk factors leading to cardio-vascular events at the long-run. Some of these metabolic disturbances have been described as relevant factors for non-alcoholic fatty liver disease (NAFLD) development. NAFLD is accepted to be the hepatic component of the metabolic syndrome, and it has been described as an independent cardiovascular risk factor. A recent study by our group found a significant increase in the prevalence of hepatic steatosis after 3 years of antipsychotic treatment in a sample of patients with psychosis. Other studies proposed that there is a link between NAFLD and severe cardio-vascular disease that may be early predicted through peripheral microvascular system signs (endothelial dysfunction). Interestingly, recent studies have shown the presence of endothelial dysfunction in psychosis, probably related to antipsychotic-exposure. In summary, the investigators consider of relevance the study of a possible interrelation between metabolic syndrome, NAFLD, and endothelial dysfunction, at long-term, and their probable correlation with antipsychotic exposure.
Based on the available scientific evidence, the investigators hypothesize that the long-term exposure to antipsychotic medication would be related to liver disease and endothelial dysfunction.
The research project would be implemented as part of a larger prospective longitudinal study on first episode non-affective psychosis, in the First Episode Psychosis Clinical Program (PAFIP). In particular, the project would be part of the "10 PAFIP study", in which those patients that had been included in the PAFIP program 10 years ago will be extensively evaluated (e.g.: clinical, neuroimaging, neuro-psychological, and metabolic evaluations) in order to analyse the long-term progress of the psychosis.
Steatosis and fibrosis indexes would be determined for 10-years time point. For those patients with scores predicting hepatic fibrosis, a full hepatic examination, including elastometry assessment (FibroScan®) with controlled attenuation parameter (CAP) and abdominal ultrasound would be carried out. Moreover, endothelial function would be examined, using EndoPAT2000® and carotid ultrasound evaluation, for those patients turning 10 years since their antipsychotic treatment was firstly prescribed.
- Conditions
- Schizophrenia, Psychosis, Metabolic Syndrome
- Keywords
- Biomarkers, Hepatic dysfunction, Metabolic dysfunction, Endothelial dysfunction, Antipsychotics, Non-alcoholic fatty liver disease
- Medical subject headings
- Schizophrenia, Psychotic Disorders, Metabolic Syndrome, Liver Diseases, Non-alcoholic Fatty Liver Disease
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence of Non-Alcoholic Fatty Liver Disease (NAFLD) diagnosed by transient elastography (FibroScan®) by spirometry.
Measured: 10 years
Secondary outcomes (1)
The presence of endothelial dysfunction measured by EndoPAT2000®.
Measured: 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2018
- Study start12 Feb 2018
- Primary completion31 Dec 2019
- Study completionDec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for SchizophreniaStudies 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
- Cross-sectional
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fundación Marques de Valdecilla
- Sponsor type
- University, hospital or other
- Collaborators
- Instituto de Investigación Marqués de Valdecilla, Consorcio Centro de Investigación Biomédica en Red (CIBER)
- Responsible party
- Principal investigator, Benedicto Crespo-Facorro, Fundación Marques de Valdecilla
- Investigators
- Javier Vázquez Bourgon, Principal investigator, Instituto de Investigación Marqués de Valdecilla
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03481465
- Sponsor's protocol ID
- HEP_10PAFIP
- Status last verified
- Dec 2020
- First submitted
- 19 Mar 2018
- Last updated
- 16 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Mayoral-van Son J, Juncal-Ruiz M, Ortiz-Garcia de la Foz V, Vazquez-Bourgon J, Setien-Suero E, Tordesillas-Gutierrez D, Gomez-Revuelta M, Ayesa-Arriola R, Crespo-Facorro B; PAFIP Research Group. Long-term clinical and functional outcome after antipsychotic discontinuation in early phases of non-affective psychosis: Results from the PAFIP-10 cohort. Schizophr Res. 2021 Jun;232:28-30. doi: 10.1016/j.schres.2021.04.011. Epub 2021 May 16. No abstract available.
PubMed 34004383Vazquez-Bourgon J, Ortiz-Garcia de la Foz V, Suarez-Pereira I, Iruzubieta P, Arias-Loste MT, Setien-Suero E, Ayesa-Arriola R, Gomez-Revuelta M, Crespo J, Crespo Facorro B. Cannabis consumption and non-alcoholic fatty liver disease. A three years longitudinal study in first episode non-affective psychosis patients. Prog Neuropsychopharmacol Biol Psychiatry. 2019 Dec 20;95:109677. doi: 10.1016/j.pnpbp.2019.109677. Epub 2019 Jun 20.
PubMed 31228640
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Searching for Early Biomarkers of Long-term Hepatic, Metabolic and Endothelial Dysfunction in Non-affective Psychosis. A 10-year Follow-up Study
- ClinicalTrials.gov ID
- NCT03481465
- Acronym / sponsor ID
- HEP_10PAFIP
- Conditions
- Schizophrenia, Psychosis, Metabolic Syndrome
- Keywords
- Biomarkers, Hepatic dysfunction, Metabolic dysfunction, Endothelial dysfunction, Antipsychotics, Non-alcoholic fatty liver disease
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Fundación Marques de ValdecillaUniversity, hospital or other
- Collaborators
- Instituto de Investigación Marqués de Valdecilla, Consorcio Centro de Investigación Biomédica en Red (CIBER)
- Study start
- 12 Feb 2018 (actual)
- Primary completion
- 31 Dec 2019 (actual)
- Study completion
- Dec 2020 (estimated)
- First posted
- 29 Mar 2018 (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.
This study aims to evaluate, at long-term, the occurrence of liver disease and cardio-vascular risk, in a sample of patients diagnosed with first episode of non-affective psychosis.
Detailed description
Schizophrenia is a severe brain disorder with an excess mortality and reduced life expectancy. It has been proposed that around 60% of this excess mortality is due to physical pathology, mostly cardio-metabolic disorders. In addition to the deleterious effects of hypercaloric diet and sedentary lifestyle, the use of antipsychotic medication has itself a significant effect on metabolism. The metabolic disturbances described related to antipsychotic exposure include weight gain and obesity, dyslipemia, and insulin-resistance or new onset diabetes mellitus, representing cardio-metabolic risk factors leading to cardio-vascular events at the long-run. Some of these metabolic disturbances have been described as relevant factors for non-alcoholic fatty liver disease (NAFLD) development. NAFLD is accepted to be the hepatic component of the metabolic syndrome, and it has been described as an independent cardiovascular risk factor. A recent study by our group found a significant increase in the prevalence of hepatic steatosis after 3 years of antipsychotic treatment in a sample of patients with psychosis. Other studies proposed that there is a link between NAFLD and severe cardio-vascular disease that may be early predicted through peripheral microvascular system signs (endothelial dysfunction). Interestingly, recent studies have shown the presence of endothelial dysfunction in psychosis, probably related to antipsychotic-exposure. In summary, the investigators consider of relevance the study of a possible interrelation between metabolic syndrome, NAFLD, and endothelial dysfunction, at long-term, and their probable correlation with antipsychotic exposure.
Based on the available scientific evidence, the investigators hypothesize that the long-term exposure to antipsychotic medication would be related to liver disease and endothelial dysfunction.
The research project would be implemented as part of a larger prospective longitudinal study on first episode non-affective psychosis, in the First Episode Psychosis Clinical Program (PAFIP). In particular, the project would be part of the "10 PAFIP study", in which those patients that had been included in the PAFIP program 10 years ago will be extensively evaluated (e.g.: clinical, neuroimaging, neuro-psychological, and metabolic evaluations) in order to analyse the long-term progress of the psychosis.
Steatosis and fibrosis indexes would be determined for 10-years time point. For those patients with scores predicting hepatic fibrosis, a full hepatic examination, including elastometry assessment (FibroScan®) with controlled attenuation parameter (CAP) and abdominal ultrasound would be carried out. Moreover, endothelial function would be examined, using EndoPAT2000® and carotid ultrasound evaluation, for those patients turning 10 years since their antipsychotic treatment was firstly prescribed.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Individuals included in the Longitudinal Long-term Study of First Episode Psychosis Clinical Program (10-PAFIP) at the University Hospital Marqués de Valdecilla (Santander - Cantabria).
Key inclusion criteria (2 listed)
- Patients followed in the First Episode Psychosis Clinical Program (PAFIP) from February 2001 to December 2007.
- Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) criteria of brief psychotic disorder, schizophreniform disorder, schizophrenia or schizoaffective disorder.
Key exclusion criteria (3 listed)
- Meeting DSM-IV criteria for drug dependence.
- Meeting DSM-IV criteria for mental retardation.
- Having a history of neurological disease or head injury.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The incidence of Non-Alcoholic Fatty Liver Disease (NAFLD) diagnosed by transient elastography (FibroScan®) by spirometry.
Time frame: 10 years
1 secondary outcome
The presence of endothelial dysfunction measured by EndoPAT2000®.
Time frame: 10 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2020.
- Derived from this study: PubMed 34004383Mayoral-van Son J, Juncal-Ruiz M, Ortiz-Garcia de la Foz V, Vazquez-Bourgon J, Setien-Suero E, Tordesillas-Gutierrez D, Gomez-Revuelta M, Ayesa-Arriola R, Crespo-Facorro B; PAFIP Research Group. Long-term clinical and functional outcome after antipsychotic discontinuation in early phases of non-affective psychosis: Results from the PAFIP-10 cohort. Schizophr Res. 2021 Jun;232:28-30. doi: 10.1016/j.schres.2021.04.011. Epub 2021 May 16. No abstract available.
- Derived from this study: PubMed 31228640Vazquez-Bourgon J, Ortiz-Garcia de la Foz V, Suarez-Pereira I, Iruzubieta P, Arias-Loste MT, Setien-Suero E, Ayesa-Arriola R, Gomez-Revuelta M, Crespo J, Crespo Facorro B. Cannabis consumption and non-alcoholic fatty liver disease. A three years longitudinal study in first episode non-affective psychosis patients. Prog Neuropsychopharmacol Biol Psychiatry. 2019 Dec 20;95:109677. doi: 10.1016/j.pnpbp.2019.109677. Epub 2019 Jun 20.
- 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.
Javier Vázquez Bourgon principal investigator
Instituto de Investigación Marqués de Valdecilla
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 Schizophrenia and Psychosis, run by Fundación Marques de Valdecilla at 1 site in Spain.
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 2 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 16 Dec 2020. 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 Spain. 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?
Results are not available in the source record.
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?
The incidence of Non-Alcoholic Fatty Liver Disease (NAFLD) diagnosed by transient elastography (FibroScan®) by spirometry. (time frame: 10 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03481465, which also lists 2 linked publications.
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 16 Dec 2020.