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Titolo:
Consistency of atypical antipsychotic superiority to placebo in recent clinical trials
Autore:
Woods, SW; Stolar, M; Sernyak, MJ; Charney, DS;
Indirizzi:
Yale Univ, Sch Med, Dept Psychiat, New Haven, CT 06519 USA Yale Univ New Haven CT USA 06519 , Dept Psychiat, New Haven, CT 06519 USA Yale Univ, Sch Med, Connecticut Mental Hlth Ctr, Treatment Res Program, New Haven, CT 06519 USA Yale Univ New Haven CT USA 06519 ent Res Program, New Haven, CT 06519 USA W Haven Vet Affairs Med Ctr, W Haven, CT USA W Haven Vet Affairs Med Ctr W Haven CT USA airs Med Ctr, W Haven, CT USA
Titolo Testata:
BIOLOGICAL PSYCHIATRY
fascicolo: 1, volume: 49, anno: 2001,
pagine: 64 - 70
SICI:
0006-3223(20010101)49:1<64:COAAST>2.0.ZU;2-T
Fonte:
ISI
Lingua:
ENG
Soggetto:
ACUTE EXACERBATION; DOUBLE-BLIND; SCHIZOAFFECTIVE DISORDER; OLANZAPINE TRIAL; SCHIZOPHRENIA; HALOPERIDOL; RISPERIDONE; EFFICACY; SAFETY; ICI-204,636;
Keywords:
equivalence; atypical antipsychotics; risperidone; olanzapine; quetiapine; meta-analysis;
Tipo documento:
Article
Natura:
Periodico
Settore Disciplinare:
Life Sciences
Citazioni:
37
Recensione:
Indirizzi per estratti:
Indirizzo: Woods, SW Yale Univ, Sch Med, Dept Psychiat, 34 Pk St, New Haven, CT 06519USA Yale Univ 34 Pk St New Haven CT USA 06519 ew Haven, CT 06519 USA
Citazione:
S.W. Woods et al., "Consistency of atypical antipsychotic superiority to placebo in recent clinical trials", BIOL PSYCHI, 49(1), 2001, pp. 64-70

Abstract

Background: The use of control placebos in clinical trials of new antipsychotic medications is increasingly under examination. The active controlled equivalence study could offer a potential alternative design, First, however; it must be clear that any proposed standard control agent has been consistently superior to placebo in previous studies. Methods: Through a Freedom of Information Act request, WE identified nine placebo-controlled trials of risperidone, olanzapine, or quetiapine. Results: Meta-analysis indicated that the pooled estimate of the true population effect size +/- SE was 0.46 +/- 0.06 for categorical response rates and >0.53 +/- 0.07 for the continuous Brief Psychiatric Rating Scale changescore outcome measure. If the desired detectable effect size is set very conservatively at a 95% confidence lower bound for the estimate of true effect size, statistical power fbr random samples of 80 per group drawn from a population of subjects similar to that of the nine meta-analyzed studies is.67 for categorical response rates and >.82 for the continuous measure, based on one-sided alpha =.05Conclusions: These data suggest substantial confidence that a therapeutic dose of an atypical antipsychotic will be statistically superior to placeboin an adequately sized randomized trial, when reporting a continuous measure as the principal outcome. Biol Psychiatry 2001;49. 64-70 (C) 2001 Society of Biological Psychiatry.

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Documento generato il 19/01/20 alle ore 15:15:58