Analyses of suicidality in double-blind, placebo-controlled trials of pharmacotherapy for weight reduction.
| Autor: | Goldstein DJ; Lilly Research Laboratories, Eli Lilly and Company, Indianapolis, IN 46285., Rampey AH Jr, Potvin JH, Masica DN, Beasley CM Jr |
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| Jazyk: | angličtina |
| Zdroj: | The Journal of clinical psychiatry [J Clin Psychiatry] 1993 Aug; Vol. 54 (8), pp. 309-16. |
| Abstrakt: | Background: The obese who seek therapy may also have depression and thus a risk for suicidality (suicidal acts and ideation). For this reason and because of interest in the potential impact of a medication with antidepressant properties on suicidality in a population without a primary diagnosis of depression, we performed a comprehensive analysis of suicidality data from clinical trials in patients seeking weight-reduction therapy. Method: Suicidality data from 11 double-blind controlled trials in the United States Investigational New Drug fluoxetine obesity clinical trial data base (3819 randomized outpatients) were reviewed. Trials lasted 6 to 60 weeks (continuous and intermittent therapy designs). They included obese men and women (median body mass index, 35.0 kg/m2). Trials excluded patients treated with antidepressants. Incidence of suicidality was analyzed by the incidence difference method. Results: No fatal suicidal acts occurred. One suicide attempt was reported in a patient receiving placebo after prior fluoxetine therapy (intermittent therapy trial). The overall incidence of suicidal ideation among fluoxetine-treated and placebo-treated patients in the obesity clinical trials was 0.24%. The difference in incidence of emergent suicidal ideation in fluoxetine-treated (0.23%) and placebo-treated patients (0.27%) was not statistically significant. Conclusion: Based on these analyses of controlled clinical trials, suicidality occurs but has a low incidence rate in the obese who seek pharmacologic weight-reduction therapy. Fluoxetine-treated and placebo-treated patients did not differ statistically significantly in the incidence of suicidality either during or after discontinuation of therapy. |
| Databáze: | MEDLINE |
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