Denne siden ble automatisk oversatt og nøyaktigheten av oversettelsen er ikke garantert. Vennligst referer til engelsk versjon for en kildetekst.

Dutch Prediction of Psychosis Study

19. april 2007 oppdatert av: 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.

Studieoversikt

Status

Ukjent

Detaljert 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.

Studietype

Observasjonsmessig

Registrering

120

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

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

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

12 år til 18 år (Barn, Voksen)

Tar imot friske frivillige

Ja

Kjønn som er kvalifisert for studier

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

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Etterforskere

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

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart

1. juni 2003

Studiet fullført (Forventet)

1. juni 2008

Datoer for studieregistrering

Først innsendt

9. september 2005

Først innsendt som oppfylte QC-kriteriene

9. september 2005

Først lagt ut (Anslag)

16. september 2005

Oppdateringer av studieposter

Sist oppdatering lagt ut (Anslag)

20. april 2007

Siste oppdatering sendt inn som oppfylte QC-kriteriene

19. april 2007

Sist bekreftet

1. april 2007

Mer informasjon

Begreper knyttet til denne studien

Andre studie-ID-numre

  • CCMOP02.0441C
  • METC02/178

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

3
Abonnere