Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
120 participants
OBSERVATIONAL
2003-06-30
2008-06-30
Brief Summary
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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
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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 (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:
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 and/or 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.
Conditions
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Study Design
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DEFINED_POPULATION
OTHER
Eligibility Criteria
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Inclusion Criteria
* 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
* Verbal IQ \< 75
* Symptoms are due to an organic mental disorder or substance abuse
12 Years
18 Years
ALL
Yes
Sponsors
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Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
OTHER
ZonMw: The Netherlands Organisation for Health Research and Development
OTHER
UMC Utrecht
OTHER
Principal Investigators
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Patricia Schothorst, PhD
Role: PRINCIPAL_INVESTIGATOR
University Medical Center Utrecht, department of Child and Adolescent Psychiatry
Herman van Engeland, Professor
Role: PRINCIPAL_INVESTIGATOR
University Medical Center Utrecht, department of Child and Adolescent Psychiatry
Locations
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University Medical Center Utrecht, department of Child and Adolescent Psychiatry
Utrecht, Utrecht, Netherlands
Countries
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Other Identifiers
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METC02/178
Identifier Type: -
Identifier Source: secondary_id
CCMOP02.0441C
Identifier Type: -
Identifier Source: org_study_id