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Early Pharmacological and Psychological Intervention for Late Prodromal States of Psychosis

23. december 2014 opdateret af: Stephan Ruhrmann, University of Cologne
The study will provide an empirical basis for a pharmacological treatment option. An open-label, randomized, multi-centre parallel group design is used. An intensified clinical management (CM), which allows needs-based psychological crisis intervention, is compared to a combination of such a CM and the atypical neuroleptic amisulpride. The central hypothesis is that the combination of a clinical management with an atypical neuroleptic is the superior treatment.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

The first diagnosis of schizophrenia is preceded by a long lasting period comprising an untreated psychotic and a prodromal state. The duration of untreated psychosis correlates with a significant worsening of several outcome variables and persons fulfilling criteria of a prodromal state are already suffering from prodromal symptoms and from a significant deterioration of social and vocational functioning. However, a sufficient strategy for early intervention is still lacking. The study will provide an empirical basis for a pharmacological treatment option. An open-label, randomized, multi-centre parallel group design is used. An intensified clinical management (CM), which allows needs-based psychological crisis intervention, is compared to a combination of such a CM and the atypical neuroleptic amisulpride. For analysis 130 patients will be recruited within three years, the treatment period is two years.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

124

Fase

  • Fase 4

Kontakter og lokationer

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

Studiesteder

  • Tyskland
    • North Rhine-Westphalia
      • Cologne, North Rhine-Westphalia, Tyskland, 50924
        • Department of Psychiatry and Psycotherapy University of Cologne

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

14 år til 36 år (Barn, Voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  1. General criteria

    • Age between 14 and 36 years
    • male or female, in- or outpatients
    • written informed consent, for patients below 18 years also signed by parents

  2. Special criteria (present within the last three months prior to the study)

    • Attenuated Positive Symptoms (APS)
    • Presence of at least one of the following symptoms: ideas of reference, odd beliefs or magical thinking, unusual perceptual experiences, odd thinking and speech, suspiciousness or paranoid ideation
    • Symptoms have to appear several times per week for a period of at least one week

AND / OR

  • Brief Limited Intermittent Psychotic Symptoms (BLIPS)
  • Duration of episode less than one week, interval between episodes at least one week
  • Symptoms resolve spontaneously
  • Presence of at least one of the following symptoms: Hallucinations, Delusions, Formal thought disorder, Gross disorganized or catatonic behavior

Exclusion Criteria:

  • Diagnostic and Statistical Manual of Mental Disorders (DSM) IV diagnosis of schizophrenia, schizophreniform,schizoaffective, delusional or bipolar disorder, at any time of life.
  • DSM-IV diagnosis of brief psychotic episode with a duration of more than one week, at any time time of life, or BLIPS within one week before inclusion.
  • DSM-IV diagnosis of delirium, dementia, amnestic and other cognitive disorders, mental retardation, mental disorders due to a general medical condition or mental disturbances due to psychotropic substances.
  • Abuse of alcohol or drugs within the last three months prior to the study; exception: cannabis user have to be drug-free during four weeks prior to the study. In case of drug abuse, it has to be determined, whether present prodromal symptoms appeared before any drug abuse; If not, symptoms have to be still present after a drug-free period of 3 months (hallucinogens, amphetamines), or four weeks (cannabis).

Studieplan

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

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Placebo komparator: supportive management
needs-focused, unspecific supportive management
Adfærdsmæssigt: Supportive management
The needs-focused intervention could include psychoeducation, crisis intervention, family counselling and assistance with education or work-related difficulties, according to need. Regular psychotherapy was not permitted.
Andre navne:
  • Clinical Management
Eksperimentel: amisulpride
24 months amisulpride 50 to 800 mg, needs-focused, unspecific supportive management.
Medicin: Amisulpride
Daily doses could range from 50 to 800 mg, with increments of 50 mg at first step and 100 mg at further steps. As a guideline, it was suggested that the dosage be increased as long as attenuated or brief limited intermittent positive symptoms were present. The interval between such steps should be at least 14 days if brief limited symptoms were absent and the APS score had improved.
Andre navne:
  • Solian

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
improvement of risk related symptoms
Tidsramme: 3, 6, 12, 24 months
Decrease of symptom scores; complete remission of risk related symptoms
3, 6, 12, 24 months

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Global functioning
Tidsramme: 3, 6, 12, 24 months
Increase of Global Assessment of Functioning (GAF) scores
3, 6, 12, 24 months

Samarbejdspartnere og efterforskere

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

Sponsor

University of Cologne

Samarbejdspartnere

German Federal Ministry of Education and Research
Heinrich-Heine University, Duesseldorf
Ludwig-Maximilians - University of Munich
Sanofi-Synthelabo
German Research Network On Schizophrenia
Department of Psychiatry University of Bonn

Efterforskere

  • Studiestol: Joachim Klosterkötter, Professor, Department of Psychiatry and Psycotherapy University of Cologne

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Hjælpsomme links

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. januar 2001

Primær færdiggørelse (Faktiske)

1. juni 2005

Studieafslutning (Faktiske)

1. juni 2005

Datoer for studieregistrering

Først indsendt

12. september 2005

Først indsendt, der opfyldte QC-kriterier

12. september 2005

Først opslået (Skøn)

20. september 2005

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

24. december 2014

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

23. december 2014

Sidst verificeret

1. december 2014

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 01 GI 9935 - P 1.1.3

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 .

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