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Non-interventional Study: Real-life Use of Atypical Antipsychotics in Acute Inpatient Management of Schizophrenia

29. november 2012 opdateret af: AstraZeneca

RECONNECT-S GAMMA : A Non-interventional Study to Observe Real-life Usage of Atypical Antipsychotics in the Acute Inpatient Management of Schizophrenia

This is an observational study describing the real-life antipsychotic treatment during the hospitalisation of the patients due to acute psychotic episode.

In this NIS subject's data will be collected at one visit at the moment of discharge from the hospital.

The results of the study would help to characterise the discrepancy between current clinical practice and treatment guidelines, indicating that atypical antipsychotics are preferable and should be used in monotherapy during acute psychotic episodes in subjects with schizophrenia. Available evidence have revealed a frequent use of first-generation antipsychotics, polypharmacy, intramuscular route of administration and use of atypical antipsychotics in doses lower than recommended in registered summary of product characteristics.

Studieoversigt

Status

Afsluttet

Betingelser

Detaljeret beskrivelse

RECONNECT-S GAMMA : A non-interventional study to observe real-life usage of atypical antipsychotics in the acute inpatient management of schizophrenia.

Undersøgelsestype

Observationel

Tilmelding (Faktiske)

503

Kontakter og lokationer

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

Studiesteder

  • Letland
      • Daugavpils, Letland
        • Research Site
      • Jelgava, Letland
        • Research Site
      • Liepaja, Letland
        • Research Site
      • Riga, Letland
        • Research Site
      • Strenci, Letland
        • Research Site
  • Rumænien
      • Bucharest, Rumænien
        • Research Site
      • Iasi, Rumænien
        • Research Site
  • Ungarn
      • Budapest, Ungarn
        • Research Site
      • Debrecen, Ungarn
        • Research Site
      • Gyor, Ungarn
        • Research Site
      • Kerepestarcsa, Ungarn
        • Research Site
      • Nyiregyhaza, Ungarn
        • Research Site
      • Szekesfehervar, Ungarn
        • Research Site
      • Szekszard, Ungarn
        • Research Site

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

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

Subjects suffering from schizophrenia being discharged from the hospital following hospitalisation due to acute psychotic episode

Beskrivelse

Inclusion Criteria:

  • Written Informed Consent has been obtained from the Subject and/or his/her legal representative (as per local regulatory requirements).
  • Meet the diagnostic criteria for schizophrenia stated in The Diagnostic and Statistical Manual of Mental Disorders, 4th edition (DSM-IV) criteria
  • Subject is hospitalised due to an acute psychotic episode

Exclusion Criteria:

  • Current participation in any clinical trial.
  • Previous enrolment in the present NIS (in case of recurrence occurred during the enrolment period)

Studieplan

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

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Kohorter og interventioner

Gruppe / kohorte
Acute psychotic episode in schizophrenia
Subjects suffering from schizophrenia being discharged from the hospital following hospitalisation due to acute psychotic episode

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Description of used atypical antipsychotic(s) during hospitalisation
Tidsramme: hospitalisation period, an expected average of 2 weeks (variable per patient)
The data will be collected at one visit at the moment of discharge from the hospital.
hospitalisation period, an expected average of 2 weeks (variable per patient)
Description of the daily dosage of atypical antipsychotic(s) during hospitalisation
Tidsramme: hospitalisation period, an expected average of 2 weeks (variable per patient)
The data will be collected at one visit at the moment of discharge from the hospital.
hospitalisation period, an expected average of 2 weeks (variable per patient)
Description of mode of administration of atypical antipsychotic(s) during hospitalisation
Tidsramme: hospitalisation period, an expected average of 2 weeks (variable per patient)
The data will be collected at one visit at the moment of discharge from the hospital.
hospitalisation period, an expected average of 2 weeks (variable per patient)

Sekundære resultatmål

Resultatmål
Tidsramme
Percent of patients with atypical antipsychotic as monotherapy
Tidsramme: hospitalisation period, an expected average of 2 weeks (variable per patient)
hospitalisation period, an expected average of 2 weeks (variable per patient)
Percent of patients with combinations of antipsychotics.
Tidsramme: hospitalisation period, an expected average of 2 weeks (variable per patient)
hospitalisation period, an expected average of 2 weeks (variable per patient)
Description of main criteria used for selection of an antipsychotic during hospitalisation.
Tidsramme: hospitalisation period, an expected average of 2 weeks (variable per patient)
hospitalisation period, an expected average of 2 weeks (variable per patient)
Description of the usage of psychometric scales in day to day practice, to evaluate the disease symptoms and thus the efficacy of treatment.
Tidsramme: hospitalisation period, an expected average of 2 weeks (variable per patient)
hospitalisation period, an expected average of 2 weeks (variable per patient)
Description of used concomitant psychiatric medication (other than atypical antipsychotic) during the hospitalization
Tidsramme: hospitalisation period, an expected average of 2 weeks (variable per patient)
hospitalisation period, an expected average of 2 weeks (variable per patient)
Description of the relationship between medication used during the hospitalization and maintenance therapy recommended upon discharge
Tidsramme: hospitalisation period, an expected average of 2 weeks (variable per patient)
hospitalisation period, an expected average of 2 weeks (variable per patient)
Description of the study population by collecting the following exploratory variables: demographic, educational, economical, social data, psychiatric and somatic health.
Tidsramme: hospitalisation period, an expected average of 2 weeks (variable per patient)
hospitalisation period, an expected average of 2 weeks (variable per patient)

Samarbejdspartnere og efterforskere

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

Sponsor

AstraZeneca

Efterforskere

  • Ledende efterforsker: Radu TEODORESCU, Prof., Spitalul Clinic of Psychiatry named after Prof. Dr. Alexandru Obregia, Romania

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. december 2011

Studieafslutning (Faktiske)

1. maj 2012

Datoer for studieregistrering

Først indsendt

9. december 2011

Først indsendt, der opfyldte QC-kriterier

13. december 2011

Først opslået (Skøn)

14. december 2011

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

30. november 2012

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

29. november 2012

Sidst verificeret

1. november 2012

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • NIS-NME-SER-2011/1

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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