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Titolo:
Symptom reduction and suicide risk in patients treated with placebo in antidepressant clinical trials: a replication analysis of the Food and Drug Administration Database
Autore:
Khan, A; Khan, SR; Leventhal, RM; Brown, WA;
Indirizzi:
NW Clin Res Ctr, Bellevue, WA USA NW Clin Res Ctr Bellevue WA USANW Clin Res Ctr, Bellevue, WA USA Duke Univ, Med Ctr, Dept Psychiat & Behav Sci, Durham, NC USA Duke Univ Durham NC USA d Ctr, Dept Psychiat & Behav Sci, Durham, NC USA Brown Univ, Dept Psychiat, Providence, RI 02912 USA Brown Univ ProvidenceRI USA 02912 ept Psychiat, Providence, RI 02912 USA
Titolo Testata:
INTERNATIONAL JOURNAL OF NEUROPSYCHOPHARMACOLOGY
fascicolo: 2, volume: 4, anno: 2001,
pagine: 113 - 118
SICI:
1461-1457(200106)4:2<113:SRASRI>2.0.ZU;2-P
Fonte:
ISI
Lingua:
ENG
Keywords:
placebo; suicide and antidepressant treatment; placebo problem; placebo-controlled trials; randomized controlled trial;
Tipo documento:
Article
Natura:
Periodico
Settore Disciplinare:
Clinical Medicine
Citazioni:
6
Recensione:
Indirizzi per estratti:
Indirizzo: Khan, A 1900 116th Ave NE 112, Bellevue, WA 98004 USA 1900 116th Ave NE 112 Bellevue WA USA 98004 ellevue, WA 98004 USA
Citazione:
A. Khan et al., "Symptom reduction and suicide risk in patients treated with placebo in antidepressant clinical trials: a replication analysis of the Food and Drug Administration Database", IN J NEUROP, 4(2), 2001, pp. 113-118

Abstract

The assumption that depressed patients who are assigned to placebo in antidepressant clinical trials are exposed to substantial morbidity and mortality has not been based on research data. Because of worldwide concern about placebo use and the implications of our earlier findings of no increased suicide risk in placebo-treated patients, we conducted a replication study ina new patient sample. We assessed suicide risk and symptom reduction amongplacebo-treated patients participating in antidepressant clinical trials for two recently approved antidepressants, venlafaxine ER and citalopram, which were unavailable during our previous study. Among 23 201 participant patients, 32 committed suicide and 172 attempted suicide. Rates of suicide and attempted suicide did not differ significantly among the placebo- and drug-treated groups. Based on patient exposure years, annual rates of suicide and attempted suicide were 0.5 and 6.7% with placebo, 0.9% with active comparator (rates for attempted suicide are unavailable), and 0.6 and 6.3 % with investigational antidepressants. Symptom reduction was 47.9% with investigational drugs (n = 1172), 47.5% with active comparators (n = 161), and 35.5% with placebo (n = 606). These data may inform discussions about the use of placebo in antidepressant clinical trials.

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Documento generato il 19/01/20 alle ore 06:02:25