Efficacy, Adverse Events, and Treatment Discontinuations in Fluoxetine Clinical Studies of Major Depression: A Meta-Analysis of the 20-mg/day Dose
J Clin Psychiatry 2000;61(10):722-728
© Copyright 2017 Physicians Postgraduate Press, Inc.
Purchase This PDF for $40.00
If you are not a paid subscriber, you may purchase the PDF.
(You'll need the free Adobe Acrobat Reader.)
Receive immediate full-text access to JCP. You can subscribe to JCP online-only ($86) or print + online ($156 individual).
With your subscription, receive a free PDF collection of the NCDEU Festschrift articles. Hurry! This offer ends December 31, 2011.
If you are a paid subscriber to JCP and do not yet have a username and password, activate your subscription now.
As a paid subscriber who has activated your subscription, you have access to the HTML and PDF versions of this item.
Click here to login.
Did you forget your password?
Still can't log in? Contact the Circulation Department at 1-800-489-1001 x4 or send email
Background: The efficacy and safety of
fluoxetine in adults with moderate-to-severe major depression are
well established. However, most analyses combined dosages (20-80
mg/day) of the compound. We hypothesized that in patients taking
20 mg/day, efficacy would be maintained but the incidence of
adverse events would be lower. We present a meta-analysis of
efficacy and safety data for fluoxetine, 20 mg/day.
Method: Data were from 3 double-blind studies (N
= 417) that included patients with moderate-to-severe major
depression (DSM-III or DSM-III-R criteria) who received placebo
or fixed-dose 20-mg/day treatment with fluoxetine. Efficacy was
assessed using the Hamilton Rating Scale for Depression (HAM-D;
HAM-D-17 total score and anxiety/somatization, retardation, sleep
disturbance, and cognitive disturbance factors) and response and
remission rates. Safety assessments included treatment-emergent
adverse events, reasons for discontinuation, and adverse events
leading to discontinuation. Adverse events were evaluated to
determine the emergence of activation and/or sedation.
Results: At 20 mg/day, fluoxetine-treated
patients demonstrated significantly greater remission and
response rates and mean changes on HAM-D-17 total score and
anxiety/somatization, retardation, and cognitive disturbance
factor scores than placebo-treated patients (p < .001). The
incidence of specific adverse events leading to discontinuation
and the frequency of study discontinuations due to adverse events
were similar among fluoxetine-treated and placebo-treated
patients (6.1% vs. 5.8%, p = .879). Several adverse events
(insomnia, asthenia, somnolence, gastroenteritis, decreased
libido, chills, and confusion) occurred significantly more
frequently among fluoxetine-treated patients. A significant
change in sedation, but not activation, occurred in patients in
the fluoxetine 20-mg/day group compared with the placebo group.
Conclusion: These data affirm that
fluoxetine at 20 mg/day is efficacious, safe, and of similar
activation potential when compared with placebo in patients with