Safety and efficacy of escitalopram in the long-term treatment of generalized anxiety disorder

Introduction: Generalized anxiety disorder (GAD) is a chronic disorder that requires long-term treatment. Escitalopram has previously been shown to be effective and well tolerated in the acute treatment of GAD. Method: Three 8-week, double-blind, placebo-controlled trials of nearly identical design were conducted of escitalopram in moderateto-severe GAD (DSM-IV criteria). Patients completing these trials were given the option of entering a 24-week, open-label, flexible-dose trial of escitalopram (10-20 mg/day). Data were collected from September 20, 2000, to August 15, 2002. Results: Two hundred ninety-nine (56.8%) of 526 patients completed 24 weeks of open-label treatment. The mean Hamilton Rating Scale for Anxiety (HAM-A) score at baseline of open-label treatment was 13.1. Long-term escitalopram treatment led to continuing improvement on all anxiety and quality-of-life (QOL) scores. Of those completing 24 weeks of treatment, 92.0% were responders (Clinical Global impressions-Improvement scale score :5 2), and the mean HAM-A score in the completer analysis was 6.9; using the last observation carried forward (LOCF), 75.9% were responders, and the mean HAM-A score in the LOCF analysis was 9.2 at endpoint. Insufficient therapeutic response and adverse events led to withdrawal of 4.2% and 9.9% of patients, respectively. Mean increase in weight from baseline was 3.0 lb. No clinically notable changes in mean laboratory, vital sign, or electrocardiographic values were observed. Conclusion: These results support the longterm tolerability and effectiveness of escitalopram in the treatment of GAD.