ObjectivesThe aim of this study was to evaluate the clinical effectiveness and tolerability of nefazodone for the treatment of depression in elderly patients in clinical routine practice.Patients and study designSeventy-nine patients with a mean age of 72.81 years, who had major depression or dysthymia according to DSM-IV criteria, were enrolled into this open label study. Patients were prescribed nefazodone starting at 50 mg/day, increasing every 4 days until a dosage of 200 mg/day was attained, and subsequently upward to 600 mg/day if no dose-limiting adverse effects appeared. Effectiveness was evaluated at the end of weeks 2, 4, 8 and 12 by completion of the Hamilton Depression Rating Scale (HAM-D), the Geriatric Depression Scale (GDS) and the Clinical Global Impressions scale. The Hamilton Anxiety Rating Scale (HAM-A), the sleep satisfaction item of the Oviedo Sleep Questionnaire (OSQ) and the Short Portable Mental Status Questionnaire (SPMSQ) were used to assess the patients at the end of week 12. Primary efficacy analysis was based on an intention-to-treat, last-observation-carried-forward data set.ResultsHAM-D scores decreased progressively from a baseline mean of 22.3 to 14.2 at the study endpoint; although this was a significant reduction, the endpoint score indicates that a significant residual symptomatology remained in the patients. Similarly, the GDS and HAM-A scores had decreased significantly by week 12. Response and remission rates were 47 and 37.5%, respectively. The percentage of patients who were satisfied, much satisfied or very much satisfied with their sleep according to the OSQ increased from 4.2% at baseline up to 62.2% at the study endpoint. A significant reduction in the SPMSQ total score was observed at the study endpoint, although the clinical relevance of this finding is doubtful. Forty-two (53.2%) patients completed the study. The most common reasons for withdrawal from the study were a lack of efficacy and adverse effects. Most adverse reactions were mild to moderate in severity and included dizziness, dry mouth, gastrointestinal distress, sedation, anxiety and malaise.ConclusionOur results suggest that nefazodone may be a well tolerated and effective alternative for treating elderly patients with depression. Although the HAM-D score at study endpoint indicated significant residual symptomatology, a similar finding has been described in several meta-analyses of antidepressant treatment in the elderly. Further research is needed to evaluate a different nefazodone dose regimen, especially a slower dose titration rate, which could result in a reduced discontinuation rate and thus a better treatment outcome.