Subject selection for placebo- and comparator-controlled trials of neuroleptics in schizophrenia

Kód výsledku v IS VaVaI

<a href="https://www.isvavai.cz/riv?ss=detail&h=RIV%2F00023752%3A_____%2F00%3A00000054" target="_blank" >RIV/00023752:_____/00:00000054 - isvavai.cz</a>

Výsledek na webu

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DOI - Digital Object Identifier

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Jazyk výsledku

angličtina

Název v původním jazyce

Subject selection for placebo- and comparator-controlled trials of neuroleptics in schizophrenia

Popis výsledku v původním jazyce

It has been suggested that inclusion of a placebo treatment arm in controlled clinical trials might bias selection of study subjects. Presumably, patients in the placebo-controlled studies are more stable but there are no data available to support such an assumption. We tested the hypothesis in a set of randomized trials of neuroleptics in schizophrenia by comparing placebo-controlled (PCT) and comparator-controlled (CCT) trials in terms of basic patients' characteristics. The results based on a total of 296 studies showed that the patients in PCT, as compared to CCT, were older (p<0.002), had a longer duration of illness (p<0.001) and a lower initial symptom severity (p<0.02). No difference was found in the number of subjects per treatment arm or in the proportion of females. However, investigation of studies which used same-gender study subjects revealed that female-only populations were more likely to be tested in PCT (p<0.03) than in CCT. In order to investigate current trends in p

Název v anglickém jazyce

Subject selection for placebo- and comparator-controlled trials of neuroleptics in schizophrenia

Popis výsledku anglicky

It has been suggested that inclusion of a placebo treatment arm in controlled clinical trials might bias selection of study subjects. Presumably, patients in the placebo-controlled studies are more stable but there are no data available to support such an assumption. We tested the hypothesis in a set of randomized trials of neuroleptics in schizophrenia by comparing placebo-controlled (PCT) and comparator-controlled (CCT) trials in terms of basic patients' characteristics. The results based on a total of 296 studies showed that the patients in PCT, as compared to CCT, were older (p<0.002), had a longer duration of illness (p<0.001) and a lower initial symptom severity (p<0.02). No difference was found in the number of subjects per treatment arm or in the proportion of females. However, investigation of studies which used same-gender study subjects revealed that female-only populations were more likely to be tested in PCT (p<0.03) than in CCT. In order to investigate current trends in p

Druh

J_x - Nezařazeno - Článek v odborném periodiku (Jimp, Jsc a Jost)

CEP obor

FL - Psychiatrie, sexuologie

OECD FORD obor

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Projekt

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Návaznosti

Z - Vyzkumny zamer (s odkazem do CEZ)

Rok uplatnění

2000

Kód důvěrnosti údajů

S - Úplné a pravdivé údaje o projektu nepodléhají ochraně podle zvláštních právních předpisů

Název periodika

Journal of Clinical Psychopharmacology

ISSN

0271-0749

e-ISSN

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Svazek periodika

20

Číslo periodika v rámci svazku

2

Stát vydavatele periodika

US - Spojené státy americké

Počet stran výsledku

6

Strana od-do

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Kód UT WoS článku

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EID výsledku v databázi Scopus

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