Analyses of suicidality in double-blind, placebo-controlled trials of pharmacotherapy for weight reduction.
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.


METHODS
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.


CONCLUSIONS
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.
Goldstein
D J
DJ
Lilly Research Laboratories, Eli Lilly and Company, Indianapolis, IN 46285.
Rampey
A H
AH
Potvin
J H
JH
Masica
D N
DN
Beasley
C M
CM
D000293:Adolescent; D000328:Adult; D000368:Aged; D000553:Ambulatory Care; D001589:Benzphetamine / Q000627:therapeutic use; D015992:Body Mass Index; D015897:Comorbidity; D003866:Depressive Disorder / Q000188:drug therapy / Q000453:epidemiology / Q000523:psychology; D004311:Double-Blind Method; D015507:Drugs, Investigational / Q000627:therapeutic use; D005260:Female; D005473:Fluoxetine / Q000627:therapeutic use*; D006801:Humans; D015994:Incidence; D008297:Male; D008875:Middle Aged; D009765:Obesity / Q000188:drug therapy* / Q000453:epidemiology / Q000523:psychology; D010919:Placebos; D013375:Substance Withdrawal Syndrome / Q000175:diagnosis / Q000453:epidemiology; D013405:Suicide / Q000706:statistics & numerical data*
D015507:Drugs, Investigational; D010919:Placebos; D005473:Fluoxetine; D001589:Benzphetamine