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NIS to Observe Improvement in Global Assessment of Functioning in Patients With Schizophrenia

13. oktober 2011 opdateret af: AstraZeneca

Non-interventional Clinical Study to Observe Improvement in Global Assessment of Functioning in Patients With Schizophrenia, Treated With Atypical Antipsychotics

The purpose of the study is to monitor the general functional changes among patients with schizophrenia, treated with atypical antipsychotics dosed once daily for a period of 6 months.The primary study objective is to compare general functioning of patients with schizophrenia treated with Seroquel SR between baseline and the last study visit. The secondary study objectives are to compare general functioning of patients with schizophrenia treated with other atypical antipsychotic medicinal products administered once daily between baseline and the last study visit, monitoring of other indicators of clinical improvement, evaluation of patient compliance and assessment of occurrence of adverse effects

Studieoversigt

Status

Afsluttet

Betingelser

Skizofreni

Undersøgelsestype

Observationel

Tilmelding (Faktiske)

106

Kontakter og lokationer

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

Studiesteder

Slovenien
- - Begunje, Slovenien
    - Research Site
  - Brezice, Slovenien
    - Research Site
  - Brezovica pri Ljubljani, Slovenien
    - Research Site
  - Idrija, Slovenien
    - Research Site
  - Koper, Slovenien
    - Research Site
  - Ljubljana, Slovenien
    - Research Site
  - Maribor, Slovenien
    - Research Site
  - Nova Gorica, Slovenien
    - Research Site
  - Novo Mesto, Slovenien
    - Research Site
  - Ormoz, Slovenien
    - Research Site
  - Postojna, Slovenien
    - Research Site
  - Radenci, Slovenien
    - Research Site
  - Sezana, Slovenien
    - Research Site
  - Vojnik, Slovenien
    - 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 til 80 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

patients visiting psychiatrist's practice

Beskrivelse

Inclusion Criteria:

patients have a diagnosis of schizophrenia, as defined by DSM-IV-TR
patients' symptoms are controlled with Seroquel SR started up to 1 month before the inclusion
or patients' symptoms are controlled with other atypical antipsychotic in once daily formulation started up to 1 month before the inclusion

Exclusion Criteria:

patients who are treated with Seroquel SR or other antipsychotic more than 1 month
patients with prescribed antipsychotic combinations
pregnant women or women who are breast-feeding
patients who have been treated with antipsychotics in depot formulations for the last two months

Studieplan

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

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Antal grupper/kohorter

Kohorter og interventioner

Gruppe / kohorte
1 Seroquel SR: Patients whose symptoms are controlled with Seroquel SR and started with the therapy up to 1 month before the inclusion
2 Atypical antipsychotics: Patients whose symptoms are controlled with atypical antipsychotic in once daily formulation (excluding Seroquel SR) and started with the therapy up to 1 month before the inclusion

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål	Tidsramme
To compare improvement in global assessment of functioning (using the GAF scale) between the baseline and the final study visit in the Seroquel SR-treated group. Tidsramme: three times: 0, 12 and 24 weeks after inclusion	three times: 0, 12 and 24 weeks after inclusion

Sekundære resultatmål

Resultatmål	Tidsramme
To assess improvement in global assessment of functioning (using the GAF scale) between the baseline and the final study visit in the group of patients treated with other atypical antipsychotics Tidsramme: three times: 0, 12 and 24 weeks after inclusion	three times: 0, 12 and 24 weeks after inclusion

Samarbejdspartnere og efterforskere

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

Sponsor

AstraZeneca

Efterforskere

Ledende efterforsker: Peter Pregelj, MD, PhD, Psihiatricna klinika Ljubljana, Studenec 48, 1260 Ljubljana

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. februar 2009

Primær færdiggørelse (Faktiske)

1. november 2010

Studieafslutning (Faktiske)

1. november 2010

Datoer for studieregistrering

Først indsendt

29. januar 2009

Først indsendt, der opfyldte QC-kriterier