Duloxetine hydrochloride, a mixed reuptake inhibitor of serotonin and noradrenaline, was studied in a 6 week open-label uncontrolled multicentre design at a dose of 20 mg daily both in in- and outpatients meeting DSM-III-R criteria for unipolar major depressive disorder. Seventy-nine patients took part in the study. The mean score on the 17-item Hamilton Depression Rating Scale at baseline was 24.9 (SD 4.4), decreasing to 8.5 (SD 7.8) after 6 weeks using a last observation carried forward analysis. Clinical response, defined as a 50% reduction in 17-item Hamilton Depression Rating Scale scores, occurred in 78.2% of patients, whereas remission, defined as a 17-item Hamilton Depression Rating Scale score of < or = 6, occurred in 60.3% of patients. Duloxetine hydrochloride was safe and well tolerated in this patient population.