Ignite Creation Date:
2024-05-05 @ 11:57 AM
Last Modification Date:
2024-10-26 @ 9:17 AM
Study NCT ID:
NCT00188981
Status:
UNKNOWN
Last Update Posted:
2007-04-20
First Post:
2005-09-09
Brief Title:
Dutch Prediction of Psychosis Study
Sponsor:
UMC Utrecht
Organization:
UMC Utrecht
Study Overview
Official Title:
Dutch Prediction of Psychosis Study
Status:
UNKNOWN
Status Verified Date:
2007-04
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
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
Detailed Description:
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
1 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
2 Prediction the systematic multi-level assessment of predictors of the transition to a first psychotic episode in subjects at risk for psychosis
3 Disability the description of disabilities deficits and needs in prodromal individuals
4 Intervention the description of the therapeutic and preventive interventions applied to prodromal individuals
While the same fundamental principles eg 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 inclusionexclusion 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 outpatients clinics because of mental problems After informed consent they are screened for the following inclusion and exclusion criteria
1 Age between 12 and 18 years
2 No previous psychotic episode for more than one week
3 Verbal IQ above 75
4 Symptoms are not due to an organic mental disorder or substance abuse
5 Belong to one or more of the following groups
1 Basic symptoms presence of self-perceived cognitive thought disturbances
2 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 andor social functioning in the last year
3 Attenuated psychotic symptoms presence of psychotic symptoms at sub-clinical level
4 Brief limited or intermittent psychotic symptoms having a history of psychotic symptoms with a duration of less than one week and spontaneous remission
5 Multiple Complex Developmental Disorder
Assessment includes
1 basic clinical assessment
2 neuropsychological measures attention memory executive functioning
3 social cognitive measures facial emotion recognition mentalizing social attribution
4 measures of social cognition and behavior
5 EEG and Event Related Potentials including smooth pursuit eye movement auditory mismatch negativity
6 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
1 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
2 Prediction the systematic multi-level assessment of predictors of the transition to a first psychotic episode in subjects at risk for psychosis
3 Disability the description of disabilities deficits and needs in prodromal individuals
4 Intervention the description of the therapeutic and preventive interventions applied to prodromal individuals
While the same fundamental principles eg 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 inclusionexclusion 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 outpatients clinics because of mental problems After informed consent they are screened for the following inclusion and exclusion criteria
1 Age between 12 and 18 years
2 No previous psychotic episode for more than one week
3 Verbal IQ above 75
4 Symptoms are not due to an organic mental disorder or substance abuse
5 Belong to one or more of the following groups
1 Basic symptoms presence of self-perceived cognitive thought disturbances
2 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 andor social functioning in the last year
3 Attenuated psychotic symptoms presence of psychotic symptoms at sub-clinical level
4 Brief limited or intermittent psychotic symptoms having a history of psychotic symptoms with a duration of less than one week and spontaneous remission
5 Multiple Complex Developmental Disorder
Assessment includes
1 basic clinical assessment
2 neuropsychological measures attention memory executive functioning
3 social cognitive measures facial emotion recognition mentalizing social attribution
4 measures of social cognition and behavior
5 EEG and Event Related Potentials including smooth pursuit eye movement auditory mismatch negativity
6 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| METC02178 | None | None | None |