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


METHODS
Three 8-week, double-blind, placebo-controlled trials of nearly identical design were conducted of escitalopram in moderate-to-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 < or = 2), and the mean HAM-A score in the completed 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.


CONCLUSIONS
These results support the long-term tolerability and effectiveness of escitalopram in the treatment of GAD.
Davidson
Jonathan R T
JR
Department of Psychiatry and Behavioral Science, Duke University Medical Center, Box 3812, Durham, N.C. 27710, USA. david011@mc.duke.edu
Bose
Anjana
A
Wang
Qin
Q
D000328:Adult; D000553:Ambulatory Care; D001008:Anxiety Disorders / Q000175:diagnosis / Q000188:drug therapy* / Q000523:psychology; D002908:Chronic Disease; D015283:Citalopram / Q000009:adverse effects / Q000627:therapeutic use*; D039721:Diagnostic and Statistical Manual of Mental Disorders; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D005260:Female; D006801:Humans; D008134:Long-Term Care; D008137:Longitudinal Studies; D008297:Male; D010919:Placebos; D011569:Psychiatric Status Rating Scales / Q000706:statistics & numerical data; D017367:Selective Serotonin Reuptake Inhibitors / Q000009:adverse effects / Q000627:therapeutic use*; D016896:Treatment Outcome
D015283:Citalopram; D010919:Placebos; D017367:Selective Serotonin Reuptake Inhibitors