Clinical trial NCT03476473: Early Detection of Respiratory Disorders in Psychosis
Official title: Early Detection of Respiratory Disorders in Psychosis
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Schizophrenia
Psychosis
Chronic Respiratory Disease
Keywords: Asthma
Chronic obstructive pulmonary disease
Spirometry
Lung disease
Smoke
Lead sponsor: Fundación Marques de Valdecilla
Sponsor class: OTHER
Collaborators: name: Instituto de Investigación Marqués de Valdecilla
name: Consorcio Centro de Investigación Biomédica en Red (CIBER)
First posted: 2018-03-26
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
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).

Brief summary: 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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* Meeting DSM-IV criteria for drug dependence.
* Meeting DSM-IV criteria for mental retardation.
* Having a history of neurological disease or head injury.

Primary outcomes:
measure: The incidence of COPD and asthma diagnosed by spirometry.
timeFrame: 10 years
Secondary outcomes:
Other outcomes:
Locations:
city: Santander
country: Spain
facility: University Hospital Marqués de Valdecilla
state: Cantabria
Study officials:
affiliation: Instituto de Investigación Marqués de Valdecilla
name: Ana Viejo Casas
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.