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Psychotic DisordersNCT00188981

Dutch Prediction of Psychosis Study

An observational study of Psychotic Disorders, run by UMC Utrecht at 1 site in Netherlands.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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

Other trials in Netherlands

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:

  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:
  6. Basic symptoms: presence of self-perceived cognitive thought disturbances
  7. 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
  8. Attenuated psychotic symptoms: presence of psychotic symptoms at sub-clinical level
  9. Brief, limited or intermittent psychotic symptoms: having a history of psychotic symptoms with a duration of less than one week and spontaneous remission
  10. 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.

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.

  1. First posted16 Sep 2005 (estimated)
  2. Study startJun 2003
  3. Study completionJun 2008 (estimated)

Resources

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
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

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.

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