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Pooled data from multiple, double-blind clinical trials comparing fluoxetine with either placebo, a tricyclic antidepressant (TCA) or both in patients with major depression were analyzed to assess the efficacy of these treatments in mild, moderate and severe depression. Fluoxetine-treated patients showed statistically significantly higher rates of response and remission than placebo-treated patients within all three severity subgroups. There were no differences in response or remission rates between fluoxetine and TCAs, regardless of symptom severity. Thus, the efficacy of fluoxetine was superior to placebo and similar to TCAs in mild, moderate and severe major depression.

A re-analysis of the profile of adverse events observed in controlled clinical trials in summarized. The data confirm that the side-effects of fluoxetine therapy are different from those of the tricyclic antidepressants (TCAs), both in type and frequency. Moreover, the superior tolerability of fluoxetine compared with the TCAs is confirmed by the significantly lower rate of premature discontinuation in the fluoxetine-treated patients than in the TCA-treated patients.