To evaluate the efficacy and tolerability of escitalopram in adult outpatients suffering from major depressive disorder, with or without comorbid anxiety in naturalistic settings.

Escitalopram has shown significant antidepressant and anxiolytic effects in placebo-controlled clinical trials of major depressive disorder and anxiety disorders.

A large, observational study was conducted in 106 investigative sites in Greece, including outpatient clinics of psychiatric hospitals participated in this 3-month, open-label, surveillance study. Efficacy assessments included the Clinical Global Impressions - Improvement scale (CGI-I) and - Severity of Illness scale (CGI-S). Tolerability assessment was based on spontaneous reported adverse events and treatment discontinuation rates.

5153 patients were enrolled (66% women) with a mean age of 46.6±11.6 years. At baseline, the mean score on the CGI-S scale was 4.4±0.9. At the end of treatment, the mean CGI-S score was 2.3±1.1 (LOCF), with 61% of patients rated as ‘normal’ (CGI-S=1) or ‘borderline ill’ (CGI-S=2). 5.1% of patients discontinued due to adverse events. The most common adverse events were gastrointestinal symptoms (5.6% of patients), anxiety (2.3%), sleep disturbance (2%), and dizziness (2%).

Escitalopram was effective for the treatment of major depressive disorder in real life clinical practice with a good tolerability profile.