Denne side blev automatisk oversat, og nøjagtigheden af ​​oversættelsen er ikke garanteret. Der henvises til engelsk version for en kildetekst.

Dutch Prediction of Psychosis Study

19. april 2007 opdateret af: UMC Utrecht

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.

Studieoversigt

Status

Ukendt

Betingelser

Detaljeret beskrivelse

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:

    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.

Undersøgelsestype

Observationel

Tilmelding

120

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

      • Utrecht, Holland
        • University Medical Center Utrecht, department of Child and Adolescent Psychiatry

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

12 år til 18 år (Barn, Voksen)

Tager imod sunde frivillige

Ja

Køn, der er berettiget til at studere

Alle

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Efterforskere

  • Ledende efterforsker: Patricia Schothorst, PhD, University Medical Center Utrecht, department of Child and Adolescent Psychiatry
  • Ledende efterforsker: Herman van Engeland, Professor, University Medical Center Utrecht, department of Child and Adolescent Psychiatry

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. juni 2003

Studieafslutning (Forventet)

1. juni 2008

Datoer for studieregistrering

Først indsendt

9. september 2005

Først indsendt, der opfyldte QC-kriterier

9. september 2005

Først opslået (Skøn)

16. september 2005

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

20. april 2007

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

19. april 2007

Sidst verificeret

1. april 2007

Mere information

Begreber relateret til denne undersøgelse

Andre undersøgelses-id-numre

  • CCMOP02.0441C
  • METC02/178

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

3
Abonner