Double-blind comparison of venlafaxine and amitriptyline in outpatients with major depression with or without melancholia

The purpose of this study was to compare the efficacy and tolerability of v enlafaxine and amitriptyline in outpatients with major depression with or w ithout melancholia. This was an 8-week, multicentre, randomized, double-bli nd, parallel-group comparison of venlafaxine and amitriptyline. Outpatients with DSM-IV major depression, a minimum score of 20 on the al-item Hamilto n Depression Rating Scale (HAM D), and depressive symptoms for at least 1 m onth were eligible. Patients were randomly assigned to venlafaxine or amitr iptyline, both drugs titrated to a maximum of 150 mg/day until study day 15 . The primary efficacy variables were the final on-therapy scores on the HA M-D, Montgomery-Asberg Depression Rating Scale and Clinical Global Impressi on severity scales. Data were evaluated on an intent-to-treat basis using t he LOCF method. One hundred and 16 patients were randomized, and 115 were e valuated for efficacy. Both drugs showed efficacy in the treatment of depre ssion with or without melancholia. No significant differences were noted be tween treatments for any efficacy parameter. However, significantly (p < 0. 05) more patients in the amitriptyline group had at least one adverse event . These results should support the efficacy and tolerability of venlafaxine in comparison with amitriptyline for treating major depression with or wit hout melancholia.