Research PapersEscitalopram 10 mg/day is effective and well tolerated in a placebo-controlled study in depression in primary careWade, A.a; Michael Lemming, O.b; Bang Hedegaard, K.b Author Information aCPS Limited, Clinical Research Centre, Glasgow, UK bH Lundbeck A/S, International Clinical Research, Copenhagen Valby, Denmark Correspondence to Ole Michael Lemming, H Lundbeck A/S, International Clinical Research, 9 Ottiliavej, DK-2500, Copenhagen Valby, Denmark Tel: +45 36 30 13 11; fax: +45 36 44 07 87; e-mail: [email protected] Received 27 December 2001 accepted 12 February 2002 International Clinical Psychopharmacology: May 2002 - Volume 17 - Issue 3 - p 95-102 Buy Abstract Escitalopram, a selective serotonin reuptake inhibitor (SSRI), was compared to placebo in a study of patients with major depressive disorder (DSM-IV) who had baseline Montgomery–Åsberg Depression Rating Scale (MADRS) total scores ≥22 and ≤40. After a 1-week, single-blind placebo period, patients were randomized to receive escitalopram 10 mg/day (n =191) or placebo (n =189) in an 8-week, double-blind period. The primary efficacy analysis of adjusted mean change in MADRS total score from baseline showed a statistically significantly larger effect for escitalopram than for placebo with a treatment difference at week 8 (last observation carried forward, LOCF) of 2.7 points (SE 0.85;P =0.002). In further by-week efficacy analyses, the effect of escitalopram was consistently larger than that of placebo (P <0.05) beginning at week 1 (Clinical Global Impression–Improvement score), week 2 (MADRS score) or week 3 (Clinical Global Impression–Severity score). Escitalopram was very well tolerated with a low overall withdrawal rate similar to that for placebo. Nausea was the only adverse event reported significantly more in escitalopram-treated patients than in placebo-treated patients, although it was infrequent and transient. Escitalopram 10 mg/day had a statistically significantly better antidepressant effect than placebo as early as week 1, and was safe and very well tolerated. © 2002 Lippincott Williams & Wilkins, Inc.