title: 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.
authors.affiliation: TN Medical College, Mumbai.
authors.forename: Charles
authors.initials: C
authors.lastname: Pinto
authors.forename: J K
authors.initials: JK
authors.lastname: Trivedi
authors.forename: G K
authors.initials: GK
authors.lastname: Vankar
authors.forename: P S V N
authors.initials: PS
authors.lastname: Sharma
authors.forename: Vikram
authors.initials: V
authors.lastname: Narasimha
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D018687:Antidepressive Agents, Second-Generation / Q000009:adverse effects / Q000627:therapeutic use*; D015283:Citalopram / Q000009:adverse effects / Q000627:therapeutic use*; D003865:Major Depressive Disorder / Q000188:drug therapy*; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D011581:Psychological Tests; D011594:Psychometrics
chemical_list: D018687:Antidepressive Agents, Second-Generation; D015283:Citalopram