A double-blind comparison of paroxetine, imipramine, and placebo in major depression.

Results from a single-center, 6-week, double-blind, randomized prospective study of paroxetine, a selective serotonin reuptake inhibitor; imipramine; and placebo are reported. One hundred twenty outpatients with a moderate-to-severe DSM-III diagnosis of major depression were randomly assigned to one of the three treatments following a 4- to 10-day single-blind placebo washout period. Significant differences favoring paroxetine over placebo were present at endpoint on most major efficacy measures. Paroxetine was also well tolerated; 5 (15%) paroxetine and 5 (14%) placebo patients dropped out of the study due to adverse effects. Imipramine, however, was comparatively poorly tolerated. Forty-five percent of imipramine-treated patients (N = 17) dropped out of the study due to adverse effects. None of the efficacy measures showed a significant difference between imipramine and placebo. This finding was probably due to the high number of imipramine patients who discontinued before they could improve. These results support the efficacy of paroxetine in the treatment of major depression and underline its favorable side effect profile compared with tricyclic antidepressants.