- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT00188981
Dutch Prediction of Psychosis Study
The Dutch Prediction of Psychosis Study (DUPS) is a prospective study of predictors of the transition to psychosis in help-seeking adolescents at high risk for developing a first psychotic episode. The aim of the project is supplemented by a systematic account of the pathways to care, the disabilities and needs and the therapeutic interventions that are currently used in this population.
Multi-level assessment includes behavioral and cognitive variables as well as structural brain imaging and neurophysiological data. Subjects will be followed up at regular intervals during (at least) two years to monitor the development of their (psychotic) symptoms. This will allow us to analyze the predictive validity of the variables.
연구 개요
상태
정황
상세 설명
The Dutch Prediction of Psychosis Study (DUPS) is a collaboration of the Academic Medical Center in Amsterdam (AMC) and the University Medical Center in Utrecht (UMC). The main objectives are:
- Pathways to care: the description of the ways subjects at risk for psychosis get access to the health care system and the detection of obstacles to adequate treatment
- Prediction: the systematic multi-level assessment of predictors of the transition to a first psychotic episode in subjects at risk for psychosis
- Disability: the description of disabilities, deficits and needs in prodromal individuals
- Intervention: the description of the therapeutic and preventive interventions applied to prodromal individuals
While the same fundamental principles (e.g. inclusion criteria) are applied in both centers, additional instruments or paradigms are added in the separate centers according to specific interests, expertise and setting.
Our specific interest is in the social cognition and social functioning of prepsychotic individuals. Therefore, in addition to the subjects that are at high risk for psychosis according to the DUPS inclusion/exclusion criteria we are including another group of subjects that is at elevated risk for psychosis, namely subjects who have a Multiple Complex Developmental Disorder (MCDD) which is a subtype of the pervasive developmental disorders.
The study is a prospective longitudinal field-study with repeated measures to monitor subjects at high risk for psychosis.
The study sample in the UMC consists of adolescents who are already referred to adolescent psychiatric outpatient's clinics because of mental problems. After informed consent they are screened for the following inclusion and exclusion criteria:
- Age between 12 and 18 years
- No previous psychotic episode for more than one week
- Verbal IQ above 75
- Symptoms are not due to an organic mental disorder or substance abuse
Belong to one or more of the following groups:
- Basic symptoms: presence of self-perceived cognitive thought disturbances
- Familial risk plus reduced functioning: having a first- or second degree relative with a history of any psychotic disorder in combination with a deterioration of mental state and/or social functioning in the last year
- Attenuated psychotic symptoms: presence of psychotic symptoms at sub-clinical level
- Brief, limited or intermittent psychotic symptoms: having a history of psychotic symptoms with a duration of less than one week and spontaneous remission
- Multiple Complex Developmental Disorder
Assessment includes:
- basic clinical assessment
- neuropsychological measures (attention, memory, executive functioning)
- social cognitive measures (facial emotion recognition, mentalizing, social attribution)
- measures of social cognition and behavior
- EEG and Event Related Potentials (including smooth pursuit eye movement, auditory mismatch negativity)
- structural MRI
Some data will be collected retrospectively upon inclusion into the study, for example symptom history and pathways to care. Outcome is assessed after 9, 18 and 24 months.
연구 유형
등록
연락처 및 위치
연구 장소
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Utrecht, 네덜란드
- University Medical Center Utrecht, department of Child and Adolescent Psychiatry
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion criteria:
Help-seeking adolescents who belong to one or more of the following groups:
- Basic symptoms: presence of self-perceived cognitive thought disturbances
- Familial risk plus reduced functioning: having a first- or second degree relative with a history of any psychotic disorder in combination with a deterioration of mental state and/or social functioning in the last year
- Attenuated psychotic symptoms: presence of psychotic symptoms at sub-clinical level
- Brief, limited or intermittent psychotic symptoms: having a history of psychotic symptoms with a duration of less than one week and spontaneous remission
- Multiple Complex Developmental disorder
Exclusion criteria:
- A previous psychotic episode for more than one week
- Verbal IQ < 75
- Symptoms are due to an organic mental disorder or substance abuse
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
공동 작업자 및 조사자
스폰서
협력자
수사관
- 수석 연구원: Patricia Schothorst, PhD, University Medical Center Utrecht, department of Child and Adolescent Psychiatry
- 수석 연구원: Herman van Engeland, Professor, University Medical Center Utrecht, department of Child and Adolescent Psychiatry
연구 기록 날짜
연구 주요 날짜
연구 시작
연구 완료 (예상)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- CCMOP02.0441C
- METC02/178
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