Unraveling the Relation of Patient's Profile and Therapeutical Effects of Atypicals, Including Quetiapine Effect (UPTAQE)
With this observational study we want to examine if the intensity of agitation, the intensity of psychotic symptoms and the presence of sleeping disorder predict the success of the treatment with a atypical antipsychotic after 12 weeks of treatment with patients with a psychotic and/or manic episode. In this study it will be examined what the percentage of patients with a 2-point improvement at the CGI-scale is. Of these group, the responders, retrospective the profile of the responders will be analysed (key-factors and confounders).
PLEASE NOTE: Seroquel SR and Seroquel XR refer to the same formulation. The SR designation was changed to XR after consultation with FDA.
Studieoversigt
Status
Betingelser
Undersøgelsestype
Tilmelding (Faktiske)
Kontakter og lokationer
Studiesteder
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Alkmaar, Holland
- Research Site
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Almelo, Holland
- Research Site
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Alphen aan de Rigjn, Holland
- Research Site
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Amersfoort, Holland
- Research Site
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Amstelveen, Holland
- Research Site
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Amsterdam, Holland
- Research Site
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Prøveudtagningsmetode
Studiebefolkning
Beskrivelse
Inclusion Criteria:
- Patients with a manic episode or patients diagnosed with schizophrenia (psychotic episode)
- Patients who start a treatment with an atypical antipsychotic : quetiapine, olanzapine or risperidone
- Patients who are prepared to consent to make the coded data available to AstraZeneca
- Patients with a CGI ≥ 4
Exclusion Criteria:
- Patients with a serious underlying disease (including renal or hepatic insufficiency, cancer, cardiovascular diseases and suchlike).
- Contra-indications for quetiapine, olanzapine or risperidone according to the SmPC for these products
- Patients unable to give informed consent according to the attending physician
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
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Quetiapin
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Risperidon
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Olanzapin
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Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Studieleder: Medical Director, AstraZeneca
Datoer for undersøgelser
Studer store datoer
Studiestart
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- NIS-NNL-SER-2005/1
- NL 401241 (Registry Identifier: NIS)
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