Escitalopram in clinical practice: results of an open-label trial in a naturalistic setting

Results from randomized, placebo-controlled clinical trials have demonstrated that escitalopram is effective and well tolerated in the treatment of depression and anxiety disorders. Such trials typically employ stringent inclusion criteria that may limit the generalizability of findings to the broader population of patients treated in psychiatric and primary care practices. The objective of the current trial was to assess the effect of escitalopram treatment on depressed outpatients in naturalistic settings. This 8-week open-label trial enrolled 5,453 outpatients aged > or = 18 years with nonpsychotic major depressive disorder from primary care (n = 2,591), psychiatric (n = 2,289), and other specialty (n = 573) practices. Escitalopram was initiated at 10 mg/day, and dose could be increased to a maximum of 20 mg/day. Efficacy measures included the Clinical Global Impressions of Improvement (CGI-I) scale, Patient Global Evaluation (PGE) scale, Hospital Anxiety and Depression Scale, Sheehan Disability Scale, and 12-Item Short Form Health Survey. Overall, 76% of patients completed 8 weeks of treatment. The mean dose of escitalopram was 11.6 mg/day. At endpoint, response rates (defined as a score < or = 2 on the CGI-I or PGE) were 68% on the clinician-assessed CGI-I and 66% on the PGE. Improvement was not related to age or response to prior antidepressant treatment. Overall, 9% of patients discontinued due to adverse events. Escitalopram treatment was well tolerated and associated with robust response rates in a broadly representative population of depressed outpatients.