NEFAZODONE IN THE TREATMENT OF SEVERE, MELANCHOLIC, AND RECURRENT DEPRESSION

The development of a new antidepressant medication is usually accompan ied by a concern as to whether or not the compound will be sufficientl y effective in clinically important subgroups of patients (e.g., depre ssed patients with increased severity of symptomatology, patients with melancholic features, and patients whose illness is recurrent). This paper describes results of a pooled analysis of four placebo-controlle d studies included in the development program of the antidepressant ne fazodone. These studies involved a total of 247 patients receiving nef azodone in a dose of up to 600 mg/day, 251 patients on placebo, and 16 6 patients receiving imipramine. For purposes of the analysis, patient s were defined as being more severely depressed (Clinical Global Impre ssions scale [CGI] psychopathology score of at least markedly ill), ha ving melancholia using DSM-III-R criteria, or having recurrent major d epression (using DSM-III-R criteria). Efficacy was assessed by improve ment in the Hamilton Rating Scale for Depression (17 items; HAM-D-17) Total score and CGI scale. Nefazodone (mean dose at endpoint = 379 mg/ day) was effective in the management of depressed patients with modera te or severe symptomatology, depressed patients with or without melanc holic features, and patients with single or recurrent episodes of depr ession.