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临床试验/NCT00173069
NCT00173069Unknown不适用

A Study on Psychopathological Progress of Early Schizophrenia-Like Disorder (SOPRES)

National Taiwan University Hospital0 个研究点目标入组 324 人开始时间: 2006年1月最近更新:
适应症

试验速览

阶段
不适用
入组人数
324

研究概览

简要总结

This PPG entitled "A Study on Psychopathological Progress of Early Schizophrenia-like Disorder (SOPRES)" is designed to study the "Progress of Psychopathology" of pre-psychotic state of schizophrenia (SCH) using a prospective follow-up design. Based on the neurodevelopment hypothesis of schizophrenia, the neurobiological dysfunctions, such as cognitive impairment, neurophysiological dysfunction, neuroanatomical pathology, is the core pathology. The pathology may exist prior to onset of psychotic symptoms, and at post psychotic state. It also presents in the first-degree relatives. SCH is mainly with a gradual mode of onset, ranging from pre-schizotypal (or pan-neurotic state), schizotypal, prodromal to frank psychotic SCH (DSM-IV criteria) state.

Up to the present time, there are arbitray criteria for diagnosing schizotypal disorder and frank psychiatric schizophrenia, but the valid clinical assessment method of pre-schizotypal and prodromal state is still controversial. The psychopathological progress from pre-schizotypal to frank psychotic SCH state is still unclear. In this SOPRES, we intend to establish a set of valid clinical assessments for defining the cases of early SCH-like disorder [ESLD], to examine the clinical progression, such as conversion rate of psychosis from non-psychotic state in a prospective longitudinal follow-up; to validate the clinically defined cases of ESLD with different dimensions of neurobiological studies, including niacin skin flush test, neuropsychological, neurophysiological (such as prepulse inhibition [PPI], P50 inhibition [P50I]), and magnetic resonance spectrometry (MRS) and Diffusion Tensor Imaging (TDI); to demonstrate the validity of the ESLD using the family genetic-epidemiological data and to explore the awareness, reaction, coping strategy, social stigma, and help seeking process of the patients and the families of ESLD.

In order to achieve these goals, we designed this PPG of SOPRES, which comprises of 4 inter-locked projects and one core unit. Project No.1 is the "Clinical Phenomenological Follow-up Study of ELSD: Clinical Validity"; Project No. 2 is the "Validity Study of Neurobiological Tests of ELSD"; Project No. 3 is the "Validity Study of Family Genetic Study of ELSD"; and Project No. 4 is the "Awareness and Pathways of Help Seeking of ELSD". The only one core unit is designed for the purposed of monitoring research progress, communication among researchers such managing PPG research meeting, data management, and budget management and other research-related administrative secretary work. These 4 projects are integrated study approaches by means of (1) using the same samples; (2) study different levels of psychopathology, including clinical symptoms, neurobiological impairment, family genetic data, and psychosocial variables; and (3) mutual hypothesis testing.

We expect that this SOPRES research will create a new frontier of SCH research in the fields of early intervention of SCH for preventing the recurrence of frank psychotic state of schizophrenia, and will provide the background for improving treatment outcome and quality of life of SCH.

详细描述

Project No: 1 Title: A Study of Psychopathological Progress of Early Schizophrenia-like Disorder specific aims are 1) To elicit the psychopathology of identified Early Schizophrenia-like Disorder (ESLD) and to categorize into 3 groups of pre-schizotypal, schizotypal, and prodromal ESLD. 2) The reveal the prevalence of different neurobiological impairment (studied in Project No.2) in 3 groups of these identified ESLD subjects. 3) The stability of psychopathology of 3 groups of identified ESLD. 4) The process of conversion and conversion rates of psychotic state from non-psychotic state in a 2-year follow-up

Study procedures:

  1. Recruitment:

The high-risk group of schizophrenia will be recruited by referral from psychiatric outpatient clinics in Northern Taiwan, referral from school counseling room in Taipei City and Taipei County, and subjects with known family history from our previous schizophrenia genetic study, which has a size of 850 families. As we have good collaborative works with several psychiatric hospitals and psychiatric departments of general hospitals, it is expected that 100 subjects could be assessed from the outpatient referral. The increasing needs of psychiatric consultation from school system give us a chance to recruit 50 subjects by school referral (school counseling system). Our previous family genetic studies in schizophrenia have already recruited 850 families. As the relatively risk of schizophrenic spectrum disorders (schizophrenia and schizotypal disorder) is much higher in families with schizophrenic patients, and in our experiences the families of schizophrenic patients often expressed worries about developing the illness themselves, it is expected that 100 subjects could be assessed from this population.

The school surveillance will be conducted in three selected senior high schools and three colleges in Taipei metropolitan aiming at subjects fitting our recruiting indicators, including cognitive decline, affective symptoms, social isolation, and school failure (CASIS). A pilot study will be conducted in initial 5-10 nominated candidate students to cross check the validity and applicability of each screening methods. There are 75,084 senior high school students in Academic Year 2003-2004 in Taipei City. We plan to survey the teachers of 3000 students to from 3 senior high schools (around 1000 students each), representing schools with highly-academic-, vocational-, and mixed-orientation. Another 3000 students will be recruited from 3 colleges by administering freshman self-report questionnaire. It is expected that 100 subjects could be identified as subjects with early schizophrenia-like clinical presentations.

研究设计

研究类型
Observational
观察模型
Defined Population
时间视角
Other

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Schizophrenia
  • one or two schizophrenia sib-paired children, one schizophrenia patient parent and the other one should be normal

排除标准

  • 未提供

研究者

申办方类型
Other

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