Evaluate the efficacy and tolerability of escitalopram in outpatients with moderate to severe depression in naturalistic settings.

Open label 24 weeks study. Efficacy assessment was based on MADRS, HAM-D, HAM-A, CGI-S and VAS scales. Tolerability was evaluated by spontaneously reported adverse events and treatment discontinuation rates. Statistical analysis was based on an intent-to-treat dataset (ITT - at least one valid post-baseline MADRS measurement, prediction of previous visits using multiple linear regression) and observed cases (OC -MADRS measurements at all 6 visits).

A total of 112 patients between 18 and 65 years old were enrolled. 52 patients (46.4%) suffered from moderate depression (22£ MADRS<30) and 60 (53.6%) from severe depression(MADRS 330). Patients had a significant improvement in their symptoms at the end of the study, as measured by a mean change in MADRS total score of 21.2 ± 7.1 (ITT, multiple linear regression). Change from baseline was bigger in regards to severity of illness (p<0.001). In addition, 89.1% of patients were evaluated as responders (at least 50% decrease in MADRS total score) and 68.2% were evaluated as remitters (MADRS£12) at the end of the study (ITT, multiple linear regression). The results were similar in the OC analysis as well. In total 33 patients (29.5%) withdrew from the study for any reason, -6 of them (5.4%) due to adverse events and 1 (0.9) due to lack of efficacy.

Escitalopram displayed very good efficacy and tolerability in a group of depressed outpatients suffering from moderate to severe illness.