H-J Möller1, S Langer, M Schmauss. 1. Klinikum der Ludwig-Maximilians-Universität München, D-80336 München, Germany. Hans-Juergen.Moeller@med.uni-muenchen.de
Abstract
INTRODUCTION: An open, multi-center, study was designed to address the efficacy and tolerability profile of treatment with escitalopram under naturalistic conditions in outpatients with depression. METHODS: A total of 11,760 patients were treated with escitalopram and followed for 8 weeks. Rating scales included the Clinical Global Impression-Severity (CGI-S), the Clinical Global Impression-Improvement (CGI-I), and a short version of the Montgomery-Asberg Depression Rating Scale (svMADRS) for assessment of various clinical parameters. RESULTS: During the course of the study, patients showed a clear pattern of improvement in their general state of health (CGI-S) and a decrease in the severity of their depression. The majority (82.8%) of patients initially received 10 mg/day escitalopram. By the end of the trial period, 32.5% of the patients were treated with 20 mg/day escitalopram compared to 64.0% receiving 10 mg/day escitalopram. After 2 weeks, 40.7% of patients were much or very much improved (CGI-I < or =2), increasing to 82.5% at the last assessment. There were no significant differences in response to treatment between women and men, with regard to treatment by specialists versus GPs, or with regard to age (< or =65 versus >65 years of age). Adverse reactions were similar to those found in controlled trials, and no new reactions were noted. The most common adverse reactions were nausea, anxiety, and vertigo. CONCLUSIONS: This observational study corroborates the high therapeutic efficacy of escitalopram treatment, while confirming the tolerability profile, in a naturalistic treatment setting.
INTRODUCTION: An open, multi-center, study was designed to address the efficacy and tolerability profile of treatment with escitalopram under naturalistic conditions in outpatients with depression. METHODS: A total of 11,760 patients were treated with escitalopram and followed for 8 weeks. Rating scales included the Clinical Global Impression-Severity (CGI-S), the Clinical Global Impression-Improvement (CGI-I), and a short version of the Montgomery-Asberg Depression Rating Scale (svMADRS) for assessment of various clinical parameters. RESULTS: During the course of the study, patients showed a clear pattern of improvement in their general state of health (CGI-S) and a decrease in the severity of their depression. The majority (82.8%) of patients initially received 10 mg/day escitalopram. By the end of the trial period, 32.5% of the patients were treated with 20 mg/day escitalopram compared to 64.0% receiving 10 mg/day escitalopram. After 2 weeks, 40.7% of patients were much or very much improved (CGI-I < or =2), increasing to 82.5% at the last assessment. There were no significant differences in response to treatment between women and men, with regard to treatment by specialists versus GPs, or with regard to age (< or =65 versus >65 years of age). Adverse reactions were similar to those found in controlled trials, and no new reactions were noted. The most common adverse reactions were nausea, anxiety, and vertigo. CONCLUSIONS: This observational study corroborates the high therapeutic efficacy of escitalopram treatment, while confirming the tolerability profile, in a naturalistic treatment setting.