Response of anxiety and agitation symptoms during nefazodone treatment of major depression.

A meta-analysis of six randomized, placebo-controlled, double-blind trials was carried out to evaluate the effectiveness of the new antidepressant nefazodone in relieving symptoms of anxiety and agitation associated with major depression. Nefazodone blocks serotonin2 (5-HT2) receptors and selectively inhibits serotonin (5-HT) reuptake. This pharmacologic profile may confer clinical benefits that differ from those of other antidepressants, such as tricyclics (TCAs) and serotonin selective reuptake inhibitors (SSRIs). The data base included 817 patients with major depression and baseline 17-item Hamilton Rating Scale for Depression (HAM-D-17) scores > or = 18; 345 received placebo, 288 imipramine, and 184 nefazodone. Both nefazodone and imipramine exhibited antidepressant efficacy compared with that of placebo, irrespective of baseline anxiety levels. Statistically significant improvement in Hamilton Rating Scale for Anxiety (HAM-A), HAM-D anxiety factor, HAM-D psychic anxiety item, and HAM-D agitation item scores was observed with both active treatments. Nefazodone-treated patients showed significantly greater improvement in somatic anxiety (HAM-D item 11) ratings than placebo-treated patients from Week 4 through end of treatment (p < or = .01), while imipramine-treated patients did not differ from placebo patients on this item. Nefazodone-treated patients improved more rapidly (as early as Week 1) than imipramine- and placebo-treated patients on agitation (HAM-D item 9) (p < or = .01). Nefazodone was found to have an excellent safety profile and was well tolerated, with 5% of nefazodone patients prematurely discontinuing treatment for adverse experiences compared with 17% for imipramine and 5% for placebo treatment.(ABSTRACT TRUNCATED AT 250 WORDS)

RCT Entities:   Population Interventions Outcomes