To evaluate the effectiveness and tolerability of escitalopram in patients suffering from depression with or without comorbid mental and/or physical disorders in a naturalistic setting.

Open-label 3-month study, conducted in 186 investigational sites in Greece. Efficacy assessment was based on CGI-S, MADRS and CGI-I scales. Tolerability was evaluated by spontaneously reported adverse events and treatment discontinuation rates. Statistical analysis was based on a modified intent-to-treat dataset (at least one valid post-baseline CGI-S measurement) and the per protocol dataset (valid CGI-S measurements at all 3 visits).

The analysis dataset of the study included 3,931 patients (mean age 45.5±10.8, 65.8% women, 37.4% with any comorbidity, and baseline mean MADRS 26.7±8.4). Patients with comorbid mental disorders were more severely ill at baseline (p< 0.001, both MADRS and CGI-S). Patients showed significant improvement (p< 0.001) during the treatment period based on both MADRS and CGI-S scores. There was no significant difference between the four groups (no comorbidity, comorbid mental disorder, comorbid physical disorders, comorbid mental and physical disorders). However, for both scales, the change from baseline increased with the severity of illness. Patients in the comorbidity groups had slightly higher overall discontinuation rates (8.2% to 10%) than patients without comorbidity (6.9%), with a total of 7.8% (n=308) Discontinuation due to adverse events was 2.3% (n=92).

Escitalopram was comparably effective and well tolerated in depressed patients with and without mental and/or somatic comorbidity.