Double‐blind dose determination study of a new antidepressant—sertraline

Abstract

AbstractAs part of a multicenter dose determination study designed to evaluate the safety and therapeutic activity of four fixed dose levels of sertraline—a new antidepressant with biochemical characteristics different from tricyclics—17 patients with diagnoses of major depressive disorder were treated with active medication under double‐blind conditions for 4 weeks following a 1‐week washout period. Patients receiving the two higher dose levels of sertraline exhibited almost no symptomatic improvement and manifested more adverse events that patients receiving the two lower dose levels. No statistically significant differences between the low‐dose groups and the placebo group were found. Thus, the efficacy of sertraline could not be demonstrated under these design constraints, although differential dose level effects were indicated. Dosage levels up to 100 mg/day would appear to be more clinically appropriate than higher dosage levels.