@article{ref1,
title="Antidepressant efficacy in relation to item analysis and severity of depression: a placebo-controlled trial of fluvoxamine versus imipramine",
journal="International clinical psychopharmacology",
year="1995",
author="Kasper, S. and Möller, H. J. and Montgomery, S. A. and Zondag, E.",
volume="9 Suppl 4",
number="",
pages="3-12",
abstract="In this investigation, the antidepressant efficacy of fluvoxamine and imipramine was compared in a randomized, double-blind, placebo-controlled study lasting 4 weeks; 338 depressed patients were recruited at five North American centres. For the efficacy analyses an intent-to-treat sample was defined. The global efficacy of the two drugs was assessed by the Hamilton Depression scale (HAM-D) and Clinical Global Impression (CGI) scores. Antidepressant activity was also assessed using the percentage of responders on the CGI &quot;improvement&quot; scale. In addition the time of onset of antidepressant effect was evaluated by weekly analysis of individual HAM-D items. The intent-to-treat sample was stratified retrospectively according to the severity of the depression (mild, moderate or severe). Regarding global efficacy, compared with placebo, only fluvoxamine significantly improved the HAM-D total scores at Week 4 (p < 0.05). There was a suggestion from individual HAM-D item scores (depressed mood, suicide, psychic anxiety) that fluvoxamine had an earlier effect than imipramine. Overall, compared with placebo, more HAM-D items were improved by fluvoxamine than imipramine. Fluvoxamine but not imipramine was significantly superior to placebo in severely depressed patients as shown by improvements in the HAM-D score (p < 0.01) and the CGI &quot;improvement&quot; score (p < 0.05). Side effect profiles for the active agents were typical for their pharmacological category:imipramine was associated with anticholinergic effects, particularly dry mouth, and fluvoxamine was associated with nausea and vomiting.<p /><p>Language: en</p>",
language="en",
issn="0268-1315",
doi="10.1097/00004850-199501004-00001",
url="http://dx.doi.org/10.1097/00004850-199501004-00001"
}