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临床试验/NCT03476473
NCT03476473Unknown不适用

Early Detection of Respiratory Disorders in Psychosis

Fundación Marques de Valdecilla1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2018年2月16日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
200
试验地点
1
主要终点
The incidence of COPD and asthma diagnosed by spirometry.

研究概览

简要总结

This study aims to evaluate the presence of lung function impairment in a sample of patients diagnosed with non-affective psychosis.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Cross Sectional

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Patients followed in the First Episode Psychosis Clinical Program (PAFIP) from February 2001 to December
  • Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) criteria of brief psychotic disorder, schizophreniform disorder, schizophrenia or schizoaffective disorder.

排除标准

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

结局指标

主要结局

The incidence of COPD and asthma diagnosed by spirometry.

时间窗: 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.

次要结局

未报告次要终点

研究者

发起方
Fundación Marques de Valdecilla
申办方类型
Other
责任方
Principal Investigator
主要研究者

Benedicto Crespo-Facorro

Associate Professor of Psychiatry

Fundación Marques de Valdecilla

研究点 (1)

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