An open-label multicentric study of the tolerability and response to escitalopram treatment in Indian patients with major depressive disorder.

ABSTRACT

To evaluate the tolerability and response to escitalopram in Indian patients with major depression, over an 8-week open-label multicentric study was carried out among 18-65 years old Indian patients suffering from DSM IV major depressive disorder with Montgomery-Asberg depression rating scale (MADRS) total score> or =22. Patients received a fixed dose of escitalopram 10 mg daily for 2 weeks, followed by flexible dose of 10 to 20 mg daily for 6 weeks. Patients were evaluated for depression and rated on MADRS score and clinical global impressions-severity (CGI-S) and--improvement (CGI-I) scores. They were monitored for treatment-emergent adverse effects. A total of 119 patients were enrolled and 103 completed the trial. There was a decrease from baseline in the MADRS total score after one week of treatment continuing until 8 weeks. By week 8, 76.9% patients had responded to treatment (> or =50% or more reduction of MADRS total score). A similar pattern of improvement to that seen with the MADRS total score was seen with CGI-S and CGI-I scores. Escitalopram was well tolerated, with only 2 patients (1.7%) withdrawing from the study due to adverse events. There were no serious adverse events.