A Double-Blind Comparison of Fluoxetine, Imipramine and Placebo in Outpatients with Major Depression

Fluoxetine is the first selective serotonin reuptake inhibitor antidepressant to he marketed in the U.S. In this double-blind trial fluoxetine was compared with imipramine and placebo among 198 outpatients with DSM-III major depression, of, whom 145 completed at least 2 weeks of active treatment and were evaluated for efficacy. Significantly fewer patients in each active drug group terminated early due to lack of efficacy compared to placebo. Both imipramine arid fluoxetine were significantly superior to placebo on most measures. There were no consistently significant differences between the two active drugs although a trend favored imipramine on a number of measures. Fluoxetine was generally well tolerated. Significantly more imipramine than placebo patients erminated early due to side-effects while fluoxetine–placebo difference was not significant. The results support previous studies which suggest fluoxetineʼs superior side-effect profile and the approximate antidepressant equivalence of fluoxetine and TCAs.