SchizophreniaNCT03476473
Early Detection of Respiratory Disorders in 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 the presence of lung function impairment in a sample of patients diagnosed with non-affective psychosis. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Schizophrenia, Psychosis, Chronic Respiratory Disease
- How many people
- 200 participants
- Where
- 1 siteSpain
- Study dates
- 16 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
This study aims to evaluate the presence of lung function impairment in a sample of patients diagnosed with non-affective psychosis.
Read the detailed description
Asthma and chronic obstructive pulmonary disease (COPD) are chronic respiratory disorders with high prevalence in the general population. Tobacco smoking is the leading risk factor for COPD, and has been associated with higher risk for uncontrolled asthma. Tobacco smoking is widely extended in the general population and is highly associated with cannabis use, which is the most consumed illicit drug in Spain. Other described risk factors for poor lung function are metabolic alterations such as insulin resistance and diabetes, and even abdominal obesity. Patients with psychosis present remarkably higher prevalence of tobacco and cannabis consumption than the general population and higher risk for developing metabolic alterations such as obesity and diabetes at the long-run.
Despite these premises, the effect of metabolic alterations and tobacco and cannabis smoking on the respiratory health has been poorly studied. Previous studies, mainly based on patients' registers showed an increased risk for COPD and uncontrolled asthma in patients with psychosis. Few studies have analysed this relation using lung function tests (spirometry), reporting reduced spirometry values in patients with schizophrenia compared with healthy controls. But little data is available on the possible causative relation of smoking (tobacco and cannabis) and metabolic alterations of COPD and un-controlled asthma in psychosis.
Based on the available scientific evidence, the investigators hypothesize that patients with psychosis will present differences in prevalence and severity of lung disease and poorer lung function, compared with the general (non-psychiatric) population, probably related to smoking (tobacco and cannabis) and metabolic alterations.
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.
Regarding the present project, a respiratory health status evaluation would be carried out cross-sectionally at this time-point (after 10 years of initiated the psychotic illness). Lung health status would be evaluated through functional test using spirometer. The clinical respiratory status would be evaluated using the following scales: the COPD Assessment Test (CAT) and the modified Medical Research Council (mMRC) Questionnaire.
- Conditions
- Schizophrenia, Psychosis, Chronic Respiratory Disease
- Keywords
- Asthma, Chronic obstructive pulmonary disease, Spirometry, Lung disease, Smoke
- Medical subject headings
- Schizophrenia, Psychotic Disorders, Asthma, Pulmonary Disease, Chronic Obstructive, Lung Diseases
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence of COPD and asthma diagnosed by spirometry.
The spirometer variables will be forced vital capacity (FVC) (i.e. the maximal volume of air, in litres, that can be forcefully expelled from the lungs after maximal inhalation) and forced expiratory volume in 1 s (FEV1) (i.e. the volume of air that can be forcefully expelled from the lungs in the first second after maximal inhalation, in litres). From a minimum of two technically acceptable and consistent efforts, the highest readings of FEV1 and FVC will be recorded and used in the analyses. Spanish reference values will be used to compute the individual FEV1 and FVC values as a percentage of those predicted for corresponding age, gender and height in healthy, non-smoking adults. Based on spirometry results, pulmonary obstruction is defined as a FEV1/FVC <70%; and restriction as a FVC <80% of the predicted value and a FEV1/FVC >70% to exclude obstruction.
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 posted26 Mar 2018
- Study start16 Feb 2018
- Primary completion26 Mar 2018
- Study completionDec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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
- Ana Viejo Casas, Principal investigator, Instituto de Investigación Marqués de Valdecilla
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03476473
- Sponsor's protocol ID
- RESP_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 34004383
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
- Early Detection of Respiratory Disorders in Psychosis
- ClinicalTrials.gov ID
- NCT03476473
- Acronym / sponsor ID
- RESP_10PAFIP
- Conditions
- Schizophrenia, Psychosis, Chronic Respiratory Disease
- Keywords
- Asthma, Chronic obstructive pulmonary disease, Spirometry, Lung disease, Smoke
- 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
- 16 Feb 2018 (actual)
- Primary completion
- 26 Mar 2018 (actual)
- Study completion
- Dec 2020 (estimated)
- First posted
- 26 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 the presence of lung function impairment in a sample of patients diagnosed with non-affective psychosis.
Detailed description
Asthma and chronic obstructive pulmonary disease (COPD) are chronic respiratory disorders with high prevalence in the general population. Tobacco smoking is the leading risk factor for COPD, and has been associated with higher risk for uncontrolled asthma. Tobacco smoking is widely extended in the general population and is highly associated with cannabis use, which is the most consumed illicit drug in Spain. Other described risk factors for poor lung function are metabolic alterations such as insulin resistance and diabetes, and even abdominal obesity. Patients with psychosis present remarkably higher prevalence of tobacco and cannabis consumption than the general population and higher risk for developing metabolic alterations such as obesity and diabetes at the long-run.
Despite these premises, the effect of metabolic alterations and tobacco and cannabis smoking on the respiratory health has been poorly studied. Previous studies, mainly based on patients' registers showed an increased risk for COPD and uncontrolled asthma in patients with psychosis. Few studies have analysed this relation using lung function tests (spirometry), reporting reduced spirometry values in patients with schizophrenia compared with healthy controls. But little data is available on the possible causative relation of smoking (tobacco and cannabis) and metabolic alterations of COPD and un-controlled asthma in psychosis.
Based on the available scientific evidence, the investigators hypothesize that patients with psychosis will present differences in prevalence and severity of lung disease and poorer lung function, compared with the general (non-psychiatric) population, probably related to smoking (tobacco and cannabis) and metabolic alterations.
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.
Regarding the present project, a respiratory health status evaluation would be carried out cross-sectionally at this time-point (after 10 years of initiated the psychotic illness). Lung health status would be evaluated through functional test using spirometer. The clinical respiratory status would be evaluated using the following scales: the COPD Assessment Test (CAT) and the modified Medical Research Council (mMRC) Questionnaire.
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 COPD and asthma diagnosed by spirometry.
Time frame: 10 years
The spirometer variables will be forced vital capacity (FVC) (i.e. the maximal volume of air, in litres, that can be forcefully expelled from the lungs after maximal inhalation) and forced expiratory volume in 1 s (FEV1) (i.e. the volume of air that can be forcefully expelled from the lungs in the first second after maximal inhalation, in litres). From a minimum of two technically acceptable and consistent efforts, the highest readings of FEV1 and FVC will be recorded and used in the analyses. Spanish reference values will be used to compute the individual FEV1 and FVC values as a percentage of those predicted for corresponding age, gender and height in healthy, non-smoking adults. Based on spirometry results, pulmonary obstruction is defined as a FEV1/FVC <70%; and restriction as a FVC <80% of the predicted value and a FEV1/FVC >70% to exclude obstruction.
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.
- 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.
Ana Viejo Casas 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 COPD and asthma diagnosed 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 NCT03476473, which also lists 1 linked publication.
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; AzTrials last refreshed its copy on 8 Nov 2026.