Psychotic DisordersNCT00188981
Dutch Prediction of Psychosis Study
An observational study of Psychotic Disorders, run by UMC Utrecht at 1 site in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Psychotic Disorders
- How many people
- 120 participants
- Where
- 1 siteNetherlands
- Study dates
- Jun 2003to Jun 2008
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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
Who cannot join
- A previous psychotic episode for more than one week
- Verbal IQ < 75
- Symptoms are due to an organic mental disorder or substance abuse
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
University Medical Center Utrecht, department of Child and Adolescent Psychiatry
Utrecht, Utrecht
About this 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.
Read the 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:
- 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.
- Conditions
- Psychotic Disorders
- Keywords
- psychosis, high risk, prodrome, Multiple Complex Developmental Disorder
- Medical subject headings
- Psychotic Disorders
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2005 (estimated)
- Study startJun 2003
- Study completionJun 2008 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Psychotic DisordersStudies of the same condition, open and under way.
- More trials run by UMC UtrechtThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Defined population
- Time perspective
- Other
- Enrolment
- 120 participants
Sponsor and investigators
- Lead sponsor
- UMC Utrecht
- Sponsor type
- University, hospital or other
- Collaborators
- Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA), ZonMw: The Netherlands Organisation for Health Research and Development
- Investigators
- Patricia Schothorst, PhD, Principal investigator, University Medical Center Utrecht, department of Child and Adolescent PsychiatryHerman van Engeland, Professor, Principal investigator, University Medical Center Utrecht, department of Child and Adolescent Psychiatry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00188981
- Sponsor's protocol ID
- CCMOP02.0441C
- Other IDs
- METC02/178
- Status last verified
- Apr 2007
- First submitted
- 9 Sep 2005
- Last updated
- 20 Apr 2007
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dutch Prediction of Psychosis Study
- ClinicalTrials.gov ID
- NCT00188981
- Acronym / sponsor ID
- CCMOP02.0441C
- Conditions
- Psychotic Disorders
- Keywords
- psychosis, high risk, prodrome, Multiple Complex Developmental Disorder
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 120 participants
- Lead sponsor
- UMC UtrechtUniversity, hospital or other
- Collaborators
- Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA), ZonMw: The Netherlands Organisation for Health Research and Development
- Study start
- Jun 2003
- Study completion
- Jun 2008 (estimated)
- First posted
- 16 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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:
- 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.
Study design
- Observational model
- Defined population
- Time perspective
- Other
Who may qualify
- Ages
- 12 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (3 listed)
- A previous psychotic episode for more than one week
- Verbal IQ < 75
- Symptoms are due to an organic mental disorder or substance abuse
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2007.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Patricia Schothorst, PhD principal investigator
University Medical Center Utrecht, department of Child and Adolescent Psychiatry
Herman van Engeland, Professor principal investigator
University Medical Center Utrecht, department of Child and Adolescent Psychiatry
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Psychotic Disorders, run by UMC Utrecht at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Apr 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Apr 2007.