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临床试验/NCT02200588
NCT02200588Unknown不适用

A Longitudinal Long-term Study (10 Years) of the Sample of First Episode of Non-affective Psychosis Individuals Included in the First Episode Psychosis Clinical Program (PAFIP)

Fundación Marques de Valdecilla1 个研究点 分布在 1 个国家目标入组 277 人开始时间: 2014年9月最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
277
试验地点
1
主要终点
Functional outcome

研究概览

简要总结

Schizophrenia is a chronic brain disease that is still understood as a condition that limits the development of a normal life for the patient who suffers it and their families. The idea that only one third of patients have a good outcome is still in force, despite the lack of clinical and epidemiological longitudinal studies that have addressed this issue rigorously. Most studies that have established the poor prognosis of the disease have followed a cross-sectional design and are based on samples of patients undergoing treatment in healthcare devices and therefore represents an important bias. Based on clinical, cognitive, functional outcome and biomarkers studies (brain imaging) to medium term (3 years) we can establish that the particular idea of poor prognosis should be reconsidered. The development of longitudinal studies of first-episode patients in representative samples of a population and long-term it is of high value to shed light on the clinical course of the disease. The belief that there are factors determining the disease progression beyond the initial three years brings us to publish this study.

Given this background, our project's main objective is to know the evolution at 10 years of patients followed in the First Episode Psychosis Clinical Program (PAFIP). Our hypothesis is that a higher percentage of expected patients have a favorable outcome of the disease. Factors such as enhancing treatment completion, abstinence from drug use, return to work, the reduction of expressed emotion in families during the early years of the disease (at least 3 years of intensive intervention PAFIP) will have a positive impact on the evolution of patients on long-term (10 years). Our hypothesis defends the existence of certain factors as independent risk factors for poor clinical and functional outcome of patients who should be known for establishing intervention strategies that attempt to mitigate their impact on the quality of life of patients and their families.

研究设计

研究类型
Observational
观察模型
Case Control
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

Functional outcome

时间窗: At 10 years

Measured by Disability Assessment Scale (DAS), Global Assessment Functioning (GAF), Quality of Life Scale (QLS), Subjective Well-being under Neuroleptic Scale (SWN-K) and Strauss-Carpenter Scale.

次要结局

  • Hospital admission(At 10 years)
  • Relapse rate(At 10 years)
  • Change in psychopathology(At 10 years)

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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