To assess the effects of treatment on symptoms of anxiety and agitation associated with depression, a data base of 2963 paroxetine treated patients was compared with 554 who received placebo and 1151 on active control. Paroxetine and active control both reduced baseline psychic anxiety more effectively than placebo. Both pharmacological treatments were effective in treating somatic anxiety with active control demonstrating an earlier onset of activity. Neither paroxetine nor active control induced new anxiety symptoms. Paroxetine was superior to placebo in the treatment of agitation at Weeks 4 and 6 and to active control at Week 4 only. Both paroxetine and active control were more protective against emergent (new) agitation than placebo. There was no difference between the three groups in the incidence of spontaneously reported adverse events indicative of anxiety.

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