A Study on Psychopathological Progress of Early Schizophrenia-Like Disorder (SOPRES)
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|ClinicalTrials.gov Identifier: NCT00173069|
Recruitment Status : Unknown
Verified July 2005 by National Taiwan University Hospital.
Recruitment status was: Not yet recruiting
First Posted : September 15, 2005
Last Update Posted : November 24, 2005
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.
|Condition or disease|
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|Study Type :||Observational|
|Estimated Enrollment :||324 participants|
|Observational Model:||Defined Population|
|Official Title:||A Study on Psychopathological Progress of Early Schizophrenia-Like Disorder (SOPRES)|
|Study Start Date :||January 2006|
|Estimated Study Completion Date :||December 2010|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00173069
|Contact: Hai-Gwo Hwu, Professor||886-2-2312-3456 ext firstname.lastname@example.org|
|Principal Investigator:||Hai-Gwo Hwu, Professor||National Taiwan University|