A multicentre, double‐blind, clomipramine‐controlled efficacy and safety study of org 3770

Abstract

AbstractThe efficacy and tolerability of the new antidepressant Org 3770 were evaluated in a multicentre, double‐blind, clomipramine‐controlled trial. In total, 174 patients (126 women and 48 men), aged 18‐75 years, who were suffering from a moderate or severe major depressive episode, were randomly assigned to 6 weeks of treatment with either Org 3770, 20–80 mg/day, or clomipramine, 50–200 mg/day. All patients were hospitalized at the time of the trial. Depressive symptoms, assessed by 21‐item HPRSD, MADRS, BPRS and GAS, improved significantly in both groups of patients after 6 weeks of treatment. Org 3770 was comparable to clomipramine with respect to improvements assessed by all the primary efficacy variables, both in moderately and severely depressed patients. Adverse clinical experiences, such as dry mouth, constipation, tremor, vertigo/dizziness, faintness on rising, and nausea, were reported by fewer patients in the Org 3770‐treated group than in the clomipramine‐treated group. These differences were particularly pronounced during the first 3 weeks of treatment. With respect to tremor, the difference between the two groups was statistically significant (p2‐sided = 0.03) after both 3 and 6 weeks of treatment. This study shows that Org 3770 is as effective as clomipramine in treating moderate or severe depression, while being better tolerated.